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S T U D Y P R O T O C O L Open Access
Lifestyle Matters for maintenance of health and
wellbeing in people aged 65 years and over:
study protocol for a randomised controlled trial
Kirsty Sprange
1*
, Gail A Mountain
1
, John Brazier
1
, Sarah P Cook
2
, Claire Craig
2
, Daniel Hind
1
, Stephen J Walters
1
,
Gill Windle
3
, Robert Woods
3
, Anju D Keetharuth
1
, Tim Chater
1
and Kath Horner
4
Abstract
Background: Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent
mental illness. However, more investment has been made into research into interventions to prevent mental illness
than into those designed to improve mental wellbeing. This applied research programme will provide high quality
evidence for an intervention designed to improve and sustain mental wellbeing in older adults.
Methods/Design: This study was a multi-centre, pragmatic, two-arm, parallel group, individually randomised
controlled trial to determine the population benefit of an occupational therapy based intervention for community
living people aged 65 years or older. Participants (n = 268) will be identified in one city in the North of England and in
North Wales through GP mail-outs, signposting by local authority, primary care staff and voluntary sector organisations
and through community engagement. Participants will be randomised to one of two treatment arms: an intervention
(Lifestyle Matters programme); or control (routine access to health and social care). All participants will be assessed at
baseline, 6 and 24 months post-randomisation. The primary outcome, which is a person reported outcome, is the
SF-36 Mental Health dimension at six months post randomisation. Secondary outcome measures have been selected
to measure psychosocial, physical and mental health outcomes. They include other dimensions of the SF36, EQ-5D-3L,
Brief Resilience Scale, General Perceived Self Efficacy Scale, PHQ-9, de Jong Gierveld Loneliness Scale, Health and Social
Care Resource Use and the wellbeing question of the Integrated Household Survey 2011. A cost effectiveness analysis
will investigate the incremental cost per Quality Adjusted Life Years (QALYs) of the Lifestyle Matters intervention
compared with treatment as usual.
Discussion: The questions being posed through this research are important given the increasing numbers of older
people, pressure on the public purse and the associated need to support good health in the extended lifespan. The
proposed trial will determine the clinical and cost effectiveness of the intervention delivered in a UK context. The
results will support commissioners and providers with decisions about implementation.
Trial registration: Current Controlled Trials ISRCTN67209155
Keywords: Lifestyle Matters, Psychosocial Intervention, Prevention, Older adults, Quality of life, Wellbeing, Mental
health, Mental wellbeing
* Correspondence: k.sprange@sheffield.ac.uk
1
School of Health and Related Research (ScHARR), University of Sheffield,
Regent Court, Regent Street, Sheffield S1 4DA, England, UK
Full list of author information is available at the end of the article
TRIALS
© 2013 Sprange et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Sprange et al. Trials 2013, 14:302
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Background
Mental wellbeing in later life is strongly associated with
healthy, active ageing, which, in turn, helps to prevent
mental illness [1-3]. It has been established that mental
wellbeing can be promoted by participation in meaningful
activities/occupations and by active engagement with life
[4-6]. Life changing events in later years, such as diagnosis
of a long term health problem or bereavement, can lead to
reduction in engagement with life which can result in
eventual decline in mental wellbeing. Prevention of this
decline could lead to reduced need for health and social
care services and promote the re-engagement of people
with their local communities. Far more investment,
however, has been made into research into interventions
to prevent mental illness than into those designed to
improve mental wellbeing [7]. This programme will pro-
vide high quality evidence for an intervention designed
to improve and sustain wellbeing, thereby contributing
towards redressing the imbalance.
The Health and Social Care Act 2012 introduced radical
changes to improve care provision in England, including
the abolition of Primary Care Trusts and the introduc-
tion of clinical commissioning groups and an NHS
Commissioning Board referred to as NHS England [8].
Further legislative change through the proposed Care
Bill (2013) in England, currently awaiting parliamentary
approval, and the draft Social Services and Well-Being
(Wales) Bill will also help drive co-ordination of health
and social care services, promote health and wellbeing
and support independent community living [9,10]. This
new integrated approach to health and social care service
provision over the lifespan could be harnessed to garner
greater investment in community based social interven-
tions to prevent decline in health and mental wellbeing
and isolation in older people.
A systematic review of evidence to support UK National
Institute for Health and Care Excellence (NICE) guidance
on interventions to promote good health and wellbeing in
older people confirmed that a US health promoting inter-
vention (Lifestyle Redesign® The American Occupational
Therapy Association, AOTA Press, USA) provided robust
effectiveness and cost effectiveness evidence [11,12]. The
intervention was able to significantly enhance the physical
and mental health, occupational functioning and life
satisfaction of community-living older adults [13,14].
Approximately 90% of the post intervention therapeutic
gain was retained at follow-up six months later [15].
Furthermore, Clarke et al. (2011) found the base case
cost per quality adjusted life year (QALY) was within
the range considered cost effective by NICE [16]. A
feasibility study conducted in Sheffield with older adults
aged 60 to 92 years tailored the intervention to a UK
context and determined that delivery was possible [17].
The result of this initial work was the Lifestyle Matters
intervention. The success of the intervention (which is a
mix of facilitated group and individual sessions) is based
on positioning the older person as the expert, thereby
facilitating improved confidence, and associated positive
behaviours. The intervention focuses on enabling partici-
pants to undertake new or neglected activities in the com-
munity, make lifestyle choices, undertake personal goal
setting and be active in their own personal development.
The overall goal is to promote long term change and
associated psychological benefit. The feasibility study
was found to harness the resources of older people and
use of community facilities rather than fostering reliance
upon statutory services [18].
Lifestyle Matters is currently recommended for imple-
mentation within UK NICE guidance (2008) and can be
located on the NHS evidence site for Quality, Productivity
and Prevention (QIPP) where it is stated that ‘results of
replication are not yet determined’[19]. The systematic
review which underpinned the NICE Guidance rated the
pilot study as being ‘sound qualitatively’but we remain re-
liant upon the results of a US randomised controlled trial
to provide population-based evidence for an intervention
that is highly dependent upon cultural context [12]. Despite
support with implementation and the extensive need that
exists amongst older people, the UK response to the NICE
Guidance has been inconsistent. The Lifestyle Matters
intervention can be delivered by either health or social care
and by the statutory or third sector and, therefore, ‘falls’be-
tween different providers, tending not to be prioritised.
Also the only evidence to support implementation of a
UK based programme (for example, the skills and compe-
tencies of service providers and UK costs for commis-
sioners of services) is limited to that identified through
the feasibility study.
The proposed research provides the opportunity to de-
termine the clinical and cost effectiveness of the Lifestyle
Matters intervention in a UK context, thereby also
adding to the national and international evidence base.
We aim to establish how mental wellbeing, self-efficacy
and resilience can be supported in community living
people aged 65 years and older. We will examine the
underlying mechanisms that can promote healthy ageing
and determine the long term sustainability of the inter-
vention. Incremental cost effectiveness will be explored
using cost effectiveness analysis and cost utility analysis in
terms of cost per QALY of the Lifestyle Matters interven-
tion compared to usual care. The results will support com-
missioners and providers with information to underpin
decisions about implementation.
Methods/Design
Trial design
The study is a multi-centre pragmatic, two-arm, parallel
group, individually randomised controlled trial, to
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investigate the implementation of a psychosocial inter-
vention, Lifestyle Matters, which aims to promote mental
wellbeing in people aged 65 years or older. Participants
recruited to the study will be randomly allocated to receive
either the Lifestyle Matters programme intervention in
addition to usual care or to usual care only which is defined
as routine access to health and social care resources. All
participants will complete the same battery of outcome
measures at baseline, 6 months and 24 months to ascertain
the benefits that might be derived from participation imme-
diately after cessation of involvement and over time. The
trial will be delivered at two study sites, one city in the
North of England and in North Wales. The trial will ad-
here to the Medical Research Council (MRC) frame-
work for the evaluation of complex interventions [20]. A
CONSORT-style flow diagram is provided in Figure 1 [21].
The study has been approved by the South Yorkshire Re-
search Ethics Committee, the National Institute for So-
cial Care and Health Research (NISCHR) Permissions
Co-ordinating Unit in Wales, Sheffield Health and So-
cial Care NHS Foundation Trust, NHS Sheffield, Shef-
field Teaching Hospitals NHS Foundation Trust, Betsi
Cadwalador University Health Board (BCUHB) and
Sheffield City Council. The trial is registered with
Current Controlled Trials, reference number
ISRCTN67209155.
Aims and objectives
The primary aim of the study is to identify how mental
wellbeing, self-efficacy and resilience can be supported
in people aged 65 years or older by:
1. Evaluating the clinical and cost effectiveness of a
psycho-social intervention to promote healthy
ageing (Lifestyle Matters) compared to usual care.
2. Examining the nature of the underlying mechanisms
that might promote self-efficacy and resilience.
3. Determining the long term sustainability of the
intervention and any associated treatment effects.
Intervention
Groups of 8 to 16 participants will attend 16 weekly
facilitated sessions over four successive months at a
local community venue. During these sessions partici-
pants will undertake activities as agreed between group
members, which may take place at the weekly venue or
within the wider community setting. Didactic sessions
relevant to the needs of specific members will also be
woven into the programme to enhance participants’
knowledge of how to overcome barriers to active en-
gagement. Each participant will be offered four individ-
ual sessions (one approximately every four weeks) with
one of the facilitators for the purposes of pursuing per-
sonal goals. The content of the intervention includes
(but is not limited to) the following themes which are
fully documented in the published manual [22].
a) Beginnings - a celebration of achievements
(mandatory)
b) Activity and Health (mandatory)
c) Growing older - changing patterns of activity goal
setting (mandatory)
d) Maintaining and improving mental wellbeing
e) Maintaining physical wellbeing
f) Occupation in the home and community
g) Safety in and around the home
h) Personal circumstances
i) Endings
Mountain et al. (2008) found that the Lifestyle Matters
programme could be delivered by non-occupational ther-
apy trained staff. Intervention facilitation will, therefore, be
conducted by equivalent NHS Agenda for Change (AfC)
Band 4 staff, for example, health trainers, health champions
or occupational therapy support workers who are specific-
ally recruited to the study. Two facilitators will deliver each
group with weekly supervision of their work being provided
by trained occupational therapists. All facilitators and su-
pervisors will receive the same two day training programme
delivered by the original author of the Lifestyle Matters
manual and receive an accompanying CD-Rom. This will
support intervention fidelitybyenablingthosedelivering
the complex intervention to learn about the programme
and work together prior to commencement. The training
will have components of group work, didactic teaching,
reflective exercises, role playing and use of scenarios.
Control arm
Participants randomised to the control arm will be asked
to continue with usual care defined as accessing health
and social care acute and community services as appropri-
ate to meet their needs. Those allocated to the control arm
will receive a Lifestyle Matters information leaflet at the
end of the study period (24 months post randomisation), to
try and prevent ‘resentful demoralisation’as a consequence
of non-involvement. The information leaflet will be derived
from the published manual and will include signposting to
local groups and services.
Welsh speakers
Groups will be offered in English, Welsh or bi-lingual,
where agreed by the group. The recruitment of Welsh
speakers will investigate population differences, accept-
ability and adherence to the intervention across national-
ities. Essential study documentation will, therefore, be
translated into Welsh by Bangor University. To ensure
standardisation across sites, all documents, including any
validated and non-validated questionnaires, not already
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6 month follow-up n = 268
Completion of Researcher and Participant Booklets
24 month follow-up n = 268
Completion of Researcher and Participant Booklets
Intervention Group n = 134
16 weekly group occupational therapy
sessions and 4 one-to-one sessions
Control Group n = 134
Usual care
Recruitment:
Community-dwelling people aged 65+ notified of study via:
Letter from GP; with, Brief study description and Response Card or,
Brief study description with Response Card; distributed via third party referrers
Study promotion text (on posters, leaflet or advert)
Expected number of approaches n = 10,000
Informed consent obtained
Baseline assessment
n = 268
Randomisation
n = 268
Randomisation triggers contact call from facilitators to
participants allocated to the intervention
Interviews
Participants - Post Intervention n = 12
(minimum across both sites and all cycles)
Facilitators - Post intervention delivery of
Cycle 1 and Cycle 3 Facilitators n = 4
(across both sites)
Cycle1 / 4 Groups / Area 1 n = 45
Cycle 2 / 4 Groups / Area 2 n = 45
Cycle 3 / 4 Groups / Areas 3 n = 44
Figure 1 Lifestyle Matters CONSORT diagram.
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available in Welsh will also be forward-back translated
(English-Welsh-English) with the back translation being
compared to the original English for harmonisation and to
clarify anomalies. A number of the patient reported out-
come measures are already available in Welsh, includ-
ingtheSF-36,EQ-5D-3L,BRSanddeJongGierveld
Loneliness scale.
Participant recruitment
A number of geographical areas will be identified in a
city in the North of England and in North Wales for re-
cruitment and subsequent intervention delivery. Recruit-
ment and intervention delivery will be in three cycles,
each cycle being cited in a community location where
the recruited participants reside. The intention is to
recruit enough participants to hold two groups of 6 to
18 participants in each location. Older adults aged 65
years and over who are living in their own home or with
others will be identified through targeted General Practi-
tioner (GP) mail-outs; signposting by health and social
care staff who are likely to come into contact with older
people in their work; community based voluntary sector
organisations for older people and through community
engagement and advertisements. A range of marketing
materials will be used to advertise the study and will be
made available in English and Welsh.
The main risk to recruitment is the GP mail-outs
where there is little control over who responds, leading
to two issues. Firstly, those who have self-identified a
need or are already confident enough to attend an inter-
vention like Lifestyle Matters and, secondly, attracting
only individuals who are already active in their personal
life and within their community. To reduce these risks,
advice will be sought from local authorities and primary
care on potential areas at both sites which currently have
limited or less access to community services and other
research-based opportunities. It is also anticipated
that regardless of individual circumstances, those who
register an interest in the study will have a personal
reason for doing so.
It is anticipated that the number and availability of
GPs will differ in each geographical location and may
introduce risk to recruitment. This will pose a greater
challenge in North Wales, which predominantly consists
of smaller, rural community GPs. In the North of England
site, which is a large city, there is anticipated to be enough
GP surgeries to conduct recruitment for two groups in
each cycle. Assistance with recruitment will, therefore, be
sought from the Primary Care Research Network (PCRN)
in England and the National NISCHR in North Wales
both of which regularly work with research active GPs.
Part of the Lifestyle Matters programme is to encourage
and support participants in arranging their own transporta-
tion to and from the weekly meetings; therefore, challenges
may arise regarding accessibility of venues. This is par-
ticularly relevant for participants living in rural areas
with limited access to public transportation. Community
venues will therefore be selected for their centrality in a
geographical area and accessibility by local public trans-
port, including buses and trams where possible, and have
adequate parking facilities. In North Wales it is antici-
pated that although some participants will be expected to
live in rural or remote areas, these individuals will already
be managing their transport needs; for example, many of
these individuals will be car owners. However, requests
by participants for support with transportation will be
managed on a case-by-case basis.
Participant eligibility
All participants will need to display reasonable cognitive
function to be able to participate in this group-based inter-
vention as evidenced by a score of 0 to 7 on the Six Item
Cognitive Impairment Test (6CIT) [23]. The 6CIT is a sim-
ple test of cognition, which shows greater sensitivity for
milder dementia than, for example, the Mini Mental State
Examination (MMSE) [24]. They will also need to be living
independently or in sheltered accommodation, alone or
with others and be able to converse in English or Welsh.
Participant screening
Participants will register an interest in the study by
returning, to the Research Team, a pre-paid response card
which is enclosed in the GP mail-out or given to the par-
ticipant by the direct referrer. Participant screening will
then be undertaken in two stages. Stage 1 is First Contact
Screening, which will be conducted when a response card
is received by the research team who then telephone the
participant and ask them to confirm their age, accommo-
dation status and establish whether they are able to con-
verse in English or Welsh. If they are eligible to proceed,
an eligibility assessment/baseline interview is arranged
which is Stage 2 of the screening process.
The participant will be sent a copy of the participant infor-
mation sheet approximately one week prior to the Eligibility
Interview. During this face-to-face assessment they will be
asked to complete the 6CIT [23]. If the individual is eligible,
they will have three options. Option one involves the as-
sessor working through the participant information sheet,
taking consent and delivering the baseline assessment
consisting of a battery of questionnaires. Informed consent
will be obtained from each participant. The participant is
then randomised to the study and notified of their study
arm allocation by a member of the research team (not the
assessor). Option 2 will allow the participant further time to
consider their decision with the researcher agreeing to future
contact with the participant. Option 3 allows the participant
to withdraw their interest in taking part in the study.
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Participant safety
If a potential participant is found not eligible during
Stage 2 of screening, based on a significant score of 8 or
more on the 6CIT, the interview will be suspended. A
significant score is an indicator of mild cognitive impair-
ment. The assessor will inform a designated member of
the research team (a registered heath professional), who
will telephone the participanttodiscussthe6CITscore,its
implications and to signpost the individual to appropriate
services. If telephone contact is not possible within one
week of the Eligibility Interview, the participant will be
sent a letter including the details outlined for the above
telephone contact. Individuals found to have a significant
score on the PHQ-9 depression scale or those whose gen-
eral behaviour raises concerns during baseline assessment,
or 6 and 24 month follow-up, will also be referred to the
designated health professional for review and potential
further contact.
As part of the recruitment process, participants will be
asked to state any current medical conditions which may
affect their ability to take part in activities undertaken as
part of the intervention. Although the facilitators will
conduct on-going monitoring of participants and their
involvement in group activities, the participants are
ultimately responsible to make independent decisions
about their level of involvement in activities. Locations
for intervention delivery will be assessed for health and
safety, including appropriate access, and warm, appro-
priate facilities including kitchen and accessible toilets.
Withdrawal
Participants will be free to withdraw at any time without giv-
ing a reason. However, where possible the reason for discon-
tinuation will be recorded. If a participant withdraws during
the study period, data already collected prior to withdrawal
will be retained and used for the purposes of the study.
Outcome measures
Participants in both the intervention and control arms will
be asked to complete the same series of patient reported
outcome measures at the same time points. The measures
will be presented in the form of two booklets at baseline, 6
month and 24 month follow-up. The first is the Assessor
Booklet, which the researcher will complete on behalf of the
participant and will consist of the following questionnaires:
SF-36 is a widely used validated reliable measure of
quality of life, functional health and wellbeing [25].
Health and Social Care Resource use questionnaire.
The second is the Participant Booklet which will be
self-completed where possible and will consist of the
following questionnaires:
Wellbeing Question from the Integrated Household
Survey 2011 is a life satisfaction measure developed
by the Office of National Statistics (ONS) [26].
EQ-5D-3L is a widely used validated measure of
health outcomes preferred by NICE in its reference
case, with UK specific preference weights [27-29].
Brief Resilience Scale is a reliable measure for
assessing resilience and ability to bounce back or
recover from stress [30].
De Jong Gierveld Loneliness Scale is a validated
instrument and reliable for measurement of overall,
emotional and social loneliness [31].
General perceived Efficacy Scale (GSE) assesses self-
beliefs used to cope with a variety of demands in
life, that is, the belief that one’s actions are
responsible for successful outcomes [32].
PHQ-9 is a validated measure of mood and anxiety,
and is widely used in primary care in the UK [33].
Participants will also be asked to complete a socio-
demographics questionnaire at baseline.
All six month follow-ups will be completed face-to-face
with participants by a blinded assessor. It is anticipated that
due to the nature of the intervention that participants,
although asked not to reveal the study arm allocation,
may inadvertently unblind assessors. Any knowledge of
study arm allocation for each participant will, there-
fore, be recorded at 6 and 24 month follow-up by the
blinded assessor. At 24 month follow-up the blinded
assessor will deliver and complete the Assessor Booklet
by telephone. The Participant Booklet will be sent by
post to the participant for self-completion, including a
return pre-paid envelope. Assistance will be provided
to participants where a need is identified, for example,
large print versions of questionnaires, telephone assistance
or a home visit.
Due to the length of time between baseline and final
assessment, a significant risk will be the potential for deteri-
oration in general health and, in particular, cognitive cap-
acity for some participants. If the accommodation needs of
a participant have changed during this time, for example, a
need to enter a residential home, this will not prevent
follow-up;however,amovetoanursinghomewillbeman-
aged on a case by case basis. Although there is no intention
to conduct the 6 Item Cognitive Impairment Test with par-
ticipants before the 24 month follow-up, the 6CIT may be
repeated to record any changes in cognitive function.
Randomisation
The Sheffield Clinical Trials Research Unit (CTRU) and
Bangor University will oversee randomisation. To ensure
that assessors are blinded to group allocation, other
designated members of the research team will complete
randomisation. This will be via a secure remote web-based
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system which will allocate each participant a unique
identification number. Details entered into the system
will include confirmation of signed consent. Participants
will then be randomly allocated to either the intervention
(n = 134) or usual care (n = 134) arm of the trial. In the
event of a couple both consenting to take part, the pair
will be randomised as a couple and not separately, that is,
to either get the intervention, or to both get usual care.
The randomisation schedule will be computer generated,
stratified by site and random permuted blocks of variable
size will be used to ensure enough participants are allocated
evenly to each arm of the trial at each site. The participant’s
GP will be notified of their involvement in the study.
Participants randomised to the control arm of the trial will
be informed by telephone and sent a letter confirming
their allocation to keep as a record. Participants allocated
to the intervention arm of the trial will first be sent a letter
confirming their allocation and including contact details
of the group facilitator(s). The participant will then be
contacted by one of the facilitators by telephone to discuss
their future involvement in the trial.
Sample size
The primary outcome for the study is the mean SF-36
Mental Health (MH) score six months post randomisation
[25]. The SF-36 MH dimension is scored on a 0 (poor) to
100 (good health) score. A previous general population
survey of 3,085 Sheffield community residents aged 75 or
more has demonstrated that the SF-36 can successfully be
used as an outcome measure in older adults living in the
community and the indications were that it was appropri-
ate and sensitive [34]. From this general population sur-
vey, the mean SF-36 MH score was 68.3 with a standard
deviation of 19.9 [34]. Differences between groups of
between 5 and 10 points on the SF-36 MH score can be
regarded as “clinically and socially relevant”[35]. The
Lifestyle Matters feasibility study suggested that improve-
ments of 7 to 14 points on the MH dimension are achiev-
able depending on baseline functioning [36]. Assuming a
standard deviation of 20 points for the SF-36 MH score at
six months post randomisation, and a mean difference in
MH scores between the two groups of eight or more points
is clinically and practically important, then to have an 80%
power of detecting this difference or more as statistically
significant at the 5% (two-sided) level will require 99 partic-
ipants per study arm (200 in total). However, the Lifestyle
Matters intervention is a group- or facilitator led interven-
tion. Therefore, the success of the intervention may depend
on the facilitator delivering it so that the outcomes of the
participants in the same group with the same facilitator
may be clustered. If an average cluster size of 10 subjects
per Lifestyle Matters facilitator group is assumed and an
intra cluster correlation of 0.01,thenthesamplesizemust
be inflated by a design effect of 1.09 to allow for this
clustering giving a revised sample size estimate of 107 par-
ticipants per group. Couples will be included in the trial
and will count as one participant. If 20% of participants
leave the study prematurely and are lost to follow-up,
then it will be necessary to recruit and randomise 134
per arm (n = 268 individuals or couples (since a couple
will count as one participant) in total).
Statistical analysis
As the trial is a pragmatic parallel group randomised
with a usual (control) treatment arm, data will be reported
and presented according to a revised CONSORT statement
[37]. Statistical analysis will beperformedonanintention-
to-treat-basis. All exploratory tests will be two-tailed with
alpha = 0.05. Baseline demographic (for example, age,
gender, number and proportion of sample who are couples)
and health related quality of life data (SF-36) will be
assessed for comparability between groups. The out-
come data to be collected are hierarchical or multi-level
in nature with individual participants nested or clustered
within couples; who are nested or clustered within the
Lifestyle Matters facilitation group who are then nested
within a treatment group. The statistical analysis, of the
outcome data, will take into account the hierarchical or
clustered nature of the data by using a multi-level mixed
effects linear regression model. Mixed effects models are
characterised by containing both fixed and random effects.
We shall assume a fixed effect for the randomised treat-
ment group but random effects for the couple and Lifestyle
Matters facilitation group. Individual participants who are
not part of a couple will be treated as clusters of size one;
similarly, participants randomised to the control usual care
group will be treated as clusters of size one (or two if they
areacouple).
To avoid bias, the independent Trial Steering Committee
(TSC), the study statisticians, health economists and the re-
search assistants collecting data at 6 and 24 months will be
blinded to treatment allocation whilst the trial is ongoing.
To remain blinded, assessors will not be made aware of
participants’allocation in the study and participants will be
asked not to inform the assessor whether they took part in
the groups when visited at 6 and 24 month follow-up. The
Trial Manager, Chief Investigator, Principal Investigators,
Fidelity assessment Lead, Trial Support Officer and partici-
pants will not be blinded.
Analysis of primary outcome
The primary analysis will compare mean SF-36 Mental
Health dimension (MH) scores at six months post ran-
domisation between the intervention group and control
arms using a random-effects or multi-level mixed effects
linear regression model to allow for the clustering of the
outcomes within couples and Lifestyle Matters facilita-
tion groups with baseline MH score as a covariate
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[38,39]. A 95% confidence interval (CI) for the mean dif-
ference SF-36 mental health dimension scores between
the intervention and control arms will also be calculated.
For the primary outcome, the SF-36 MH score at six
months follow-up, missing data will be imputed using
multiple imputations with age, gender and baseline MH
scores as predictors.
Analysis of secondary outcomes
Secondary outcomes, such as the other dimensions of the
SF-36, EQ-5D-3L, BRS, GSE, de Jong Gierveld Loneliness
Scale at six months’follow-up, will be compared between
the intervention and control arm using a multi-level mixed
effects linear regression model with baseline score as a co-
variate. A 95% CI for the mean difference in this parameter
between the treatment groups will also be calculated.
Participants will be followed up at 24 months post random-
isation. Mean SF-36 (MH), other SF-36 dimensions, BRS,
GSE, PHQ-9, EQ-5D-3L, de Jong Gierveld Loneliness Scale
dimensionscoresat24months’follow-up will be compared
again using multi-level mixed effects linear regression
model with baseline score as a covariate. A 95% CI for the
mean difference in this parameter between the treatment
groups will also be calculated.
Cost effectiveness analysis
A trial based economic evaluation will be undertaken of
an intention-to-treat comparison of the costs and out-
comes of the two trial arms. A cost effectiveness analysis
will be undertaken of the incremental cost per QALYs of
the Lifestyle Matters intervention compared with treat-
ment as usual [40]. QALYs will be calculated using the
SF-6D preference-based index derived from the SF-36
administered at baseline, 6 and 24 months [41]. The
QALY gain from the intervention will be estimated using
a standard area under the curve calculation. A sensitivity
analysis will be undertaken using utility values from the
EQ-5D, also collected in the trial [27]. The total cost
consequences of the intervention will be estimated at
the individual participant level and will include the costs
of providing the four month Lifestyle Matters intervention
and the subsequent consequences for the use of routine
health and social care services. A detailed costing of the
weekly facilitated sessions will be undertaken, including
recruitment (though postal invitation), administration, hire
of local community venues, facilitator salaries, refresh-
ments participant travel if required and any materials used.
Care will be undertaken to exclude all research costs.
Resources will be costed using local price data to estimate a
total cost per session. The number of participants attending
each session will be recorded and an average level of
capacity used to estimate an average cost per attendance.
Finally, this estimate will be applied to the actual number
of sessions each participant attended.
A potentially important benefit of the intervention is
that it may result in important cost savings to the NHS.
The use of services by trial participants will be collected
in detail using a Health and Social Care Service Use
Questionnaire that will be administered by telephone or
face to face. Interviewer administration is essential in
order to obtain accurate and useable data on the use of all
NHS and Personal and Social Services. Service use will be
costed using most recent National Reference Cost Data and
Unit Costs of Health and Social Care [42,43]. Missing data
will be dealt with using multiple imputation for SF-6D and
resource use data [44]. The central analysis of mean incre-
mental costs per QALY will be subjected to a full sensitivity
analysis of key parameters including the measure used
to estimate QALYs and number participants at the weekly
sessions. A full probabilistic sensitivity analysis will be
performed to examine the probability of cost effectiveness
of the intervention for the NHS for different levels of costs
and QALY gains [45]. There will also be a supplementary
cost consequences analysis that will include the other out-
come measures [40].
Maintaining participant involvement
Due to the long study period (24 months), two strategies
will be employed to keep participants engaged with the
trial. Firstly, a newsletter will be sent by post at approxi-
mately 7, 14 and 21 months providing information and
an update on study progress. Secondly, a prize draw will
take place at the end of the 6 and 24 month follow-ups
for each of the three cycles at each site. Participants will
only be entered into the prize draw on return of their
completed questionnaires. Participants will be informed
of the prize draw when they are notified of their group
allocation post randomisation.
Fidelity assessment
We will conduct a fidelity assessment to explore the
appropriateness of the facilitator training, supervision
and subsequent intervention adherence. Fidelity checks
will assess how well the Lifestyle Matters programme is
delivered according to the intervention protocol and the
published manual. Checks will adhere to an intervention
fidelity framework based on that identified by the Behaviour
Change Consortium and NICE guidance on behaviour
change [46,47]. Table 1 provides an overview of the fidelity
assessment and quality assurance parameters described by
Bellg et al. (2004), including intervention design, training,
delivery, receipt and enactment [46].
The efficacy of facilitator training and supervision will
be evaluated using a number of methods. All facilitators
and supervisors will receive the same two day training
delivered by the same trainer. The training will be ob-
served by two participant researchers and an observation
checklist will be used to evaluate delivery and receipt of
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the training. A purposive selection of intervention group
meetings will be video recorded at each site by the facilita-
tors. Two researchers will then assess intervention delivery
using an observation checklist based on the contents of
the manualised programme and two day training. Findings
from the checklists will be used to identify any areas of
concern regarding failure to deliver the intervention as
per the intervention protocol and manualised programme.
This study recognises the complexities of balancing con-
ducting high quality research with that of delivering an
intervention in a real world setting. It is appreciated,
therefore, that to maintain intervention fidelity, a level of
feedback is required to help develop facilitator under-
standing and skills during delivery of the programme
based on the findings of the fidelity assessment. One of
the purposes of high level research is to highlight such
inadequacies, for example, in training provision that may
affect intervention fidelity, but also to ensure that study
fidelity is not lost. Facilitators will be asked to complete
reflective diaries and a supervisor protocol will be pro-
vided as a guidance document for those involved in super-
vising facilitators.
Table 1 Lifestyle Matters RCT fidelity assessment strategy (adapted from Bellg et al. [46])
Goal Description Fidelity
Trial Design Comparable treatment All participants have received the
same programme tailored to the
needs of the group/setting.
•16 weekly meetings will be offered to all participants
with delivery of a minimum of 8.
•Four, one-to-one meetings will be offered to all participants.
Uptake and attendance recorded by the facilitator.
Risk to implementation Plan for potential issues that could
affect the delivery of the Lifestyle
Matters programme.
•A range of recruitment strategies will be implemented
including GP mail-outs for each geographical area, referrals
from health and social care, referrals from third sector and
posters/leaflets.
•A pre-arranged set of days and times for weekly meetings
will be offered from which participants can choose.
•Undertake three recruitment cycles in three geographically
separate areas, one per cycle, to prevent saturation.
Monitoring
provider
training
Standardised training and
facilitator skill acquisition
All facilitators receive the same
training programme tailored to
the group/setting.
•Observation of the training session by two researchers
using a content checklist (evidence of skill transference as
demonstrated through, for example, role playing activities
and reflective exercises).
All facilitators understand and engage
with the intervention programme
training in a similar way.
•Training delivered by the same trainer.
•Manual and CD-Rom provided to all trainees.
•Completion of training exercises by facilitators.
Monitoring
intervention
delivery
Standardised delivery All facilitators use the same techniques
and content from the programme.
•Observation using a content checklist by two researchers.
•75% of opportunities for completing goal setting are
recorded (both for individual and group).
•Range of materials from the Lifestyle Matters programme
received by all participants.
•Facilitators maintain reflective diaries.
•Weekly facilitator record from group meetings.
•Participant and facilitator semi-structured interviews.
•All participants receive certificate of attendance/
achievement.
•Facilitators meet the NHS Band 4 equivalent job description.
Minimise drift in
skills/delivery
Adherence to training content and
delivery over the three cycles of the
intervention.
•Observation using a content checklist by two researchers
•OT supervisor protocol.
•Each facilitator will attend between 8 and 16 sessions in
total of which half should be delivered face-to face.
Monitoring receipt
of intervention
Participant attendance
and engagement
Record the numbers of participants
attending the programme each week
•Registers completed by facilitators for weekly meetings
and one-to-one sessions where arranged.
All participants take part in the group
meetings and activities
•75% of opportunities for completing goal setting are
recorded (both for individual and group).
Impact of intervention on participant
in terms of well-being
•Participant and facilitator semi-structured interviews.
•Patient Reported Outcome Measures (PROMS).
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A number of tools will be used to monitor participant
engagement and adherence to the Lifestyle Matters
programme, including attendance registers for weekly
meetings and individual one-to-one sessions. Receipt of the
intervention will be monitored using participant semi-
structured interviews to explore perceptions and attitudes
towards the programme. We will also interview at least one
intervention facilitator at bothsitesduringthefirstand
third cycle of the intervention to elicit their experience of
the training and subsequent programme delivery.
Process evaluation
A qualitative sub-study will evaluate the impact of the
Lifestyle Matters programme upon older people’s health
and wellbeing and to identify factors which may mediate
or moderate the effectiveness of the intervention. This
will include identifying the mechanisms perceived to
promote self-efficacy and resilience, evaluating the imple-
mentation of the intervention and eliciting participants’
experiences of the intervention. Semi-structured interviews
will be undertaken with both participants and facilitators
to explore their experience of the Lifestyle Matters inter-
vention. Interview themes will include:
How older people experience the programme and its
delivery;
What issues promote the effectiveness of
intervention facilitation;
The skills and competencies required to facilitate the
programme;
The barriers and facilitators to its uptake and
continued use;
The effect of the Lifestyle Matters programme on
the social behaviours of older people.
All interviews lasting approximately 60 minutes will be
conducted in a convenient location for the participant
and audio recorded with consent. Transcripts of inter-
views will undergo respondent validation. This will be
achieved by asking participants and facilitators to read
through the transcript of their interview and comment on
its accuracy. For the purposes of reporting, confidentiality
will be assured by removing all identifiable or recognisable
information.
Participant interviews will be conducted with a pur-
posive sample of around 10% of participants allocated to
the intervention across both sites and from all three cycles
to elicit the range and nature of issues that influence their
experiences of the interventions and perceived advantages
and disadvantages. A sample frame will be used to identify
the purposive sample which will be based on a range of
characteristics, including sex, age, nationality, ethnicity,
resident status, marital status, education, occupation and
current levels of social and community based activity.
Interviews will be conducted where possible within two
weeks of attending their last group meeting.
Facilitator interviews will be conducted with at least
one facilitator at each site. Because the facilitators will
ideally remain the same throughout the whole study, the
interviews will be conducted at the end of cycle one and
cycle three. These will identify any changes in the facilita-
tor’s experience of delivering the intervention between cycle
one when they first receive and implement their training
through to the third cycle when a more practiced and profi-
cient delivery would be expected. Should there be a need
for a replacement facilitator to take over a group, they will
also be included in the interviews.
The following patient reported outcome measures, the
Brief Resilience Scale, de Jong Gierveld Loneliness scale
and the General Perceived Self Efficacy (GSE) Scale, will
be used to evaluate the impact of the Lifestyle Matters
programme upon resilience, self-efficacy and loneliness.
Analysis
Analysis of the semi-structured interviews will commence
at the end of each data collection period (intervention
cycle). The same methods of analysis will be applied to
both the participant and facilitator interviews. Transcripts
of interviews will be entered into NVivo and Framework
Analysis used to examine each respondent’sdatawithin
an overall framework that is related to the intervention
process. The thematic framework will be identified by two
researchers and an index developed which will then be
used to recode the transcripts and the data will then be
charted and mapped for interpretations to develop
explanations to understand the processes underlying the
programme. Results will also be used to explore potential
explanations for the quantitative findings and identify
whether there are other emerging factors influencing
uptake and impact of the intervention.
Trial monitoring
Trial set-up and monitoring have been agreed upon
with the study sponsor, the University of Sheffield. A
Data Management and Monitoring Plan (DMMP) will
be implemented at both sites (Sheffield and Bangor),
including periodic assessment during recruitment, 6
and 24 month follow-up and study closure. Monitoring
visits will include source data verification checks, data
completeness checks and individual staff interviews to
discuss study procedures. Additional assessments will
be performed if a need is identified.
Data management
The CTRU will undertake data management and ensure
the trial is conducted according to Good Clinical Practice
(GCP) Guidelines and local standard operating procedures.
Data will be collected and retained in accordance with the
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Data Protection Act 1998. Anonymised trial data will be
entered into a secure validated web based database system
(Prospect) developed and hosted by the CTRU. The trial
will allocate a unique screening and participant identi-
fication number to each participant. Any information
provided by a participant will be handled in confidence,
except where there is an issue of safety, in which the par-
ticipants GP will be notified with their consent. Research
participants will be protected by the removal of any recog-
nisable, personal, confidential or sensitive data.
A requirement of the MRC LLHWB Cross-Council
Programme is that primary outcome data resulting from
the trial are shared with the wider research community
through the UK Data Archive. Consent to share these
data will be sought from participants. We will also obtain
permission to share participants’personal information
with the Data Linkage Service (NHS IC), including name,
address and date of birth in order to obtain regular health
status reports during the period of follow-up, the purpose
being, to prevent unnecessary contact with participants
who may have died during this time.
Trial oversight committees
The conduct of the trial will be overseen by three commit-
tees according to the CTRU standard operating procedures.
The committees will include a Trial Management group
(TMG), a Trial Steering Committee (TSC) and a Data
Monitoring and Ethics Committee (DMEC). The TMG will
consist of key individuals directly involved in the develop-
ment and delivery of the trial including the PI, CI, Study
Manager and collaborators. There will also be lay represen-
tation from an older person. The TMG will design and
deliver all aspects of the trial and act on recommendations
of the TSC and DMEC. The TSC will be composed of
an independent chair and members with expertise in
delivering RCTs and trial monitoring. The TSC will advise
the CI on aspects of trial implementation, provide supervi-
sion of the trial protocol and statistical analysis plan,
monitor trial progress and provide advice and consider
recommendations from the DMEC. The DMEC will be
composed of an independent Chair, Statistician and content
expert. The DMEC is responsible for monitoring participant
safety, monitoring trial results in accordance with the
statistical analysis plan and providing recommendations
to the TSC regarding trial continuation due to issues of
ethics, safety and serious adverse events.
Discussion
Robust and high quality research, in particular pragmatic
trials in a UK setting, is required to help support service
providers, health and social care managers and clinicians
when making decisions about implementing evidence-based
psycho-social interventions. Although Lifestyle Matters is
already an established manualised programme and is being
implemented sporadically in the UK by health and social
care services, evidence from high level research of improved
health and mental wellbeing outcomes in older people will
be required before improvements in implementation will
become visible. The proposed research will determine the
clinical and cost effectiveness of an occupational therapy
based psychosocial intervention (Lifestyle Matters) for
people aged 65 years and older in a UK context, in-
cluding any long term effects of sustainability.
Trial status
Recruitment commenced on the 14 August 2012.
Abbreviations
6CIT: Six Item Cognitive Impairment Test; AfC: Agenda for Change;
BCUHB: Betsi Cadwalador University Health Board; CTRU: Sheffield Clinical
Trials Research Unit; GCP: Good Clinical Practice; DMMP: Data Management
and Monitoring Plan; MH: Mental health; MMSE: Mini Mental State
Examination; MRC: Medical Research Council; NHS: National health service;
NICE: National Institute for Health and Care Excellence; NISCHR: National
Institute for Social Care and Health Research; PCRN: Primary Care Research
Network; PROMs: Patient Reported Outcome Measures; QALYs: Quality
Adjusted Life Years; QIPP: Quality, Productivity and Prevention; TSC: Trial
Steering Committee.
Competing interests
GM and CC are the original authors of the published Lifestyle Matters
manualised programme. No other authors have any competing interests.
Authors’contributions
KS contributed to study design, development of trial protocol, development
and preparation of supporting documents, and development of the
manuscript. GM contributed to the study concept, study design,
development and review of trial protocol, and the review of supporting
documents. JB contributed to the study design, development and review of
trial protocol, and the review of supporting documents. SC contributed to
the study design, development and review of trial protocol, and the
development and review of supporting documents. CC contributed to the
study concept, study design, review of trial protocol and the review of
supporting documents. DH contributed to the study design, development
and review of trial protocol, and the development and review of supporting
documents. SW contributed to the study design, development and review of
trial protocol, development and review of supporting documents, and the
statistical analysis plan. GW contributed to the study design, review of trial
protocol, and the development and review of supporting documents. RW
contributed to the study design, review of trial protocol, and the review of
supporting documents. ADK contributed to the study design, development
and review of trial protocol, and the review of supporting documents. TC
contributed to the study design, review of trial protocol, and development
and review of supporting documents. KH contributed to the review of trial
protocol, and the development and review of supporting documents. All
authors read and approved the final manuscript.
Acknowledgements
The trial is funded through the Medical Research Council (MRC) Lifelong
Health and Wellbeing (LLHW) programme, grant number G1001406, ISRCTN
is 67209155. The grantholders are Professors Mountain (Sheffield), Brazier
(Sheffield), Walters (Sheffield), Woods (Bangor) and Drs Hind (Sheffield),
Windle (Bangor) and Cook (Sheffield Hallam) and Mrs Craig (Sheffield
Hallam). The views and opinions expressed in this paper are those of the
authors and do not necessarily reflect those of the MRC. Primary Care
Research Network (PCRN) funding was accessed to support recruitment
activity in GP surgeries in Sheffield and NISCHR provided support in North
Wales. The funder has reviewed and approved the study design including
methods of data collection, analysis and interpretation of data. Dr Pip Logan,
Dr Jennifer Wenborn, Dr Linda Sheppard, Dr Fiona Goudie of the Trial
Steering Committee (TSC) and Dr Mona Kanaan, Prof Avril Drummond and
Dr Claire Ballinger of the Data Monitoring and Ethics Committee (DMEC)
Sprange et al. Trials 2013, 14:302 Page 11 of 13
http://www.trialsjournal.com/content/14/1/302
advised on and critically reviewed the trial protocol. Ms Maggie Spencer
reviewed the trial protocol and supporting documents as an invaluable older
person representative.
Author details
1
School of Health and Related Research (ScHARR), University of Sheffield,
Regent Court, Regent Street, Sheffield S1 4DA, England, UK.
2
Centre for
Health and Social Care Research, Montgomery House, 32 Collegiate Crescent,
Collegiate Campus, Sheffield Hallam University, Sheffield S10 2BP, England,
UK.
3
Dementia Services Development Centre, Institute of Medical and Social
Care Research, Prifysgol Bangor University, 45 College Road, Bangor,
Gwynedd, Wales, UK.
4
NHS Sheffield, 722 Prince of Wales Road, Sheffield S9
4EU, England, UK.
Received: 23 April 2013 Accepted: 4 September 2013
Published: 21 September 2013
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doi:10.1186/1745-6215-14-302
Cite this article as: Sprange et al.:Lifestyle Matters for maintenance of
health and wellbeing in people aged 65 years and over: study protocol
for a randomised controlled trial. Trials 2013 14:302.
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