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Collegian
25
(2018)
385–394
Contents
lists
available
at
ScienceDirect
Collegian
j
o
ur
nal
ho
mepage:
www.elsevier.com/locate/coll
Behaviour
change
interventions
to
improve
medication
adherence
in
patients
with
cardiac
disease:
Protocol
for
a
mixed
methods
study
including
a
pilot
randomised
controlled
trial
Ali
Hussein
Alek
Al-Ganmia,b,∗,
Lin
Perrya,c,
Leila
Gholizadeha,
Abdulellah
Modhi
Alotaibia,d
aUniversity
of
Technology
Sydney,
Faculty
of
Health,
UTS
Building
10,
Level
7,
235-253
Jones
Street,
Ultimo,
Sydney,
NSW,
2007,
Australia
bUniversity
of
Baghdad,
College
of
Nursing,
Bab
Al-Muadahm
Square,
Baghdad,
Iraq
cPrince
of
Wales
Hospital,
G74,
East
Wing,
Edmund
Blacket
Building,
Barker
Street,
Randwick,
NSW,
2031,
Australia
dShqra
University,
Faculty
of
Applied
Health
Sciences,
Shqra,
Saudi
Arabia
a
r
t
i
c
l
e
i
n
f
o
Article
history:
Received
28
July
2017
Received
in
revised
form
1
October
2017
Accepted
6
October
2017
Keywords:
Cardiac
disease
Medication
adherence
Pilot
randomised
controlled
trial
Motivational
interviewing
Text
messaging
Nursing
a
b
s
t
r
a
c
t
Background:
Suboptimal
adherence
to
medication
increases
mortality
and
morbidity;
individually
tai-
lored
supportive
interventions
can
improve
patients’
adherence
to
their
medication
regimens.
Aims:
The
study
aims
to
use
a
pilot
randomised
controlled
trial
(RCT)
to
test
the
hypothesis
that
a
theory-
based,
nurse-led,
multi-faceted
intervention
comprising
motivational
interviewing
techniques
and
text
message
reminders
in
addition
to
standard
care
will
better
promote
medication
adherence
in
cardiac
patients
compared
to
standard
care
alone.
The
pilot
study
will
assess
self-reported
adherence
or
non-
adherence
to
cardiovascular
medication
in
patients
referred
to
a
cardiac
rehabilitation
program
following
hospital
admission
for
an
acute
cardiac
event
and
test
the
feasibility
of
the
intervention.
The
study
will
examine
the
role
of
individual,
behavioural
and
environmental
factors
in
predicting
medication
non-
adherence
in
patients
with
CVD.
Methods:
This
is
a
mixed-
methods
study
including
a
nested
pilot
RCT.
Twenty-eight
cardiac
patients
will
be
recruited;
an
estimated
sample
of
nine
patients
in
each
group
will
be
required
for
the
pilot
RCT
with
80%
power
to
detect
a
moderate
effect
size
at
5%
significance,
and
assuming
50%
loss
to
follow-up
over
the
six
month
intervention.
Participants
will
complete
a
paper-based
survey
(Phase
one),
followed
by
a
brief
semi-structured
interview
(Phase
two)
to
identify
their
level
of
adherence
to
medication
and
determine
factors
predictive
of
non-adherence.
Participants
identified
as
‘non-adherent’
will
be
eligible
for
the
pilot
randomised
trial,
where
they
will
be
randomly
allocated
to
receive
either
the
motivational
interview
plus
text
message
reminders
and
standard
care,
or
standard
care
alone.
Discussion:
Nurse-led
multi-faceted
interventions
have
the
potential
to
enhance
adherence
to
cardiac
medications.
The
results
of
this
study
may
have
relevance
for
cardiac
patients
in
other
settings,
and
for
long-term
medication
users
with
other
chronic
diseases.
©
2017
Australian
College
of
Nursing
Ltd.
Published
by
Elsevier
Ltd.
1.
Introduction
World-wide,
the
prevalence
of
cardiovascular
disease
(CVD)
is
increasing
rapidly
because
of
changes
in
population
lifestyles
(Hauptman,
2008),
resulting
in
major
concerns
for
community
health
(Zhu,
Wang,
Zhu,
Zhou,
&
Wang,
2015).
Cardiovascular
disease
has
emerged
as
a
leading
cause
of
death
and
disability
∗Corresponding
author
at:
University
of
Technology
Sydney,
Faculty
of
Health,
UTS
Building
10,
Level
7,
235-253
Jones
Street,
Ultimo,
Sydney,
NSW,
2007,
Australia.
E-mail
addresses:
alihalek@yahoo.com,
ali.h.al-ganmi@student.uts.edu.au
(A.H.A.
Al-Ganmi).
in
Australia
(Nichols,
Peterson,
Alston,
&
Allender,
2014),
affect-
ing
one
in
six
people
and
responsible
for
16%
of
the
nations’
total
disease
burden.
It
is
the
main
reason
for
rehospitalisation
(Australian
Institute
of
Health
and
Welfare,
2014);
costs
in
2004–5
of
AU$5.94
billion
accounted
for
11%
of
Australia’s
total
health
expenditure
(Australian
Institute
of
Health
and
Welfare,
2010).
Quality
of
life
has
been
shown
7to
improve
for
patients
with
CVD
referred
to
a
comprehensive
cardiac
rehabilitation
and
secondary
prevention
program
(Shepherd
&
While,
2012).
These
programs
comprise
recovery
and
preventative
activities
aimed
at
modifying
cardiac
risk
factors
and
enhancing
physico-psycho-social
function
to
reduce
the
risk
of
subsequent
cardiac
events
(Woodruffe
et
al.,
2014).
Cardiac
rehabilitation
enables
changes
in
patient
lifestyles
https://doi.org/10.1016/j.colegn.2017.10.003
1322-7696/©
2017
Australian
College
of
Nursing
Ltd.
Published
by
Elsevier
Ltd.
386
A.H.A.
Al-Ganmi
et
al.
/
Collegian
25
(2018)
385–394
Summary
of
Relevance
Problem
Cardiovascular
disease
remains
one
of
the
leading
causes
of
morbidity
and
mortality
in
Australia
and
worldwide.
What
is
already
known
Adherence
to
cardiovascular
medication
is
suboptimal,
increasing
the
risk
of
mortality
and
morbidity.
What
this
paper
adds
This
is
the
first
multi-method
pilot
randomised
controlled
trial
of
an
intervention
comprising
motivational
interviewing
techniques
and
text
reminders
delivered
by
nurses
to
pro-
mote
adherence
to
medication.
Outcomes
will
support
the
development
of
a
full-scale
trial
of
the
intervention
in
cardiac
rehabilitation
and
other
health
care
areas,
and
to
patients
with
other
chronic
conditions
who
take
long-term
medications.
by
providing
education
and
development
of
skills
to
reduce
car-
diovascular
risk
factors,
and
to
promote
adherence
to
prescribed
medications.
Prescription
medications,
an
important
form
of
secondary
pre-
vention
for
CVD,
have
been
a
key
factor
in
the
20%
reduction
seen
in
mortality
rates
within
one
year
of
diagnosis
of
acute
myocar-
dial
infarction
(AMI)
(Chase,
Bogener,
Ruppar,
&
Conn,
2016);
and
the
28%
reduction
within
three
months
of
AMI
between
2006
and
2007
(Kolandaivelu,
Leiden,
Gara,
&
Bhatt,
2014).
While
cardiac
medications
have
been
shown
to
be
effective
for
symptom
manage-
ment
and
slowing
the
progression
of
CVD,
consistent
adherence
to
prescribed
medication
regimes
is
required
to
achieve
these
effects
(Hunt
et
al.,
2009).
The
World
Health
Organisation
(WHO)
defines
adherence
as
‘the
extent
to
which
a
person’s
behaviour
(taking
medications,
fol-
lowing
a
recommended
diet
and/or
executing
lifestyle
changes)
corresponds
with
the
agreed
recommendations
of
a
healthcare
provider’
(Sabaté,
2003,
p.
3).
Adherence
to
medications
is
a
chal-
lenge,
particularly
for
patients
with
cardiac
disease
who
often
require
multiple
medications
for
prolonged
periods
(World
Health
Organisation,
2003).
The
risk
of
mortality
and
morbidity
in
such
patients
increases
if
adherence
to
prescribed
medication
is
subop-
timal
(Hope,
Wu,
Tu,
Young,
&
Murray,
2004);
yet
reported
rates
of
non-adherence
vary
from
33%
to
more
than
50%
(Li,
Kuo,
Hwang,
&
Hsu,
2012;
Munger,
Van
Tassell,
&
LaFleur,
2007;
Shah,
Desai,
Gajjar,
&
Shah,
2013),
contributing
to
increased
numbers
of
CVD-related
Emergency
Department
visits,
hospitalisation,
reduced
health
and
well-being,
augmented
healthcare
costs
and
risk
of
death
(Mukhtar,
Weinman,
&
Jackson,
2014;
Whittle
et
al.,
2016).
It
is
therefore
important
to
identify
the
factors
that
influence
medication
adher-
ence
(Munger
et
al.,
2007)
and
provide
tailored
interventions
to
improve
patients’
medication-taking
behaviours
(Santo
et
al.,
2016).
2.
Background
Medication
adherence
is
linked
to
better
clinical
outcomes
among
patients
with
heart
disease,
reducing
the
risk
of
hospi-
tal
readmission
and
death
(Ruppar,
Cooper,
Mehr,
Delgado,
&
Dunbar-Jacob,
2016).
Suboptimal
medication
adherence
is
a
mul-
tidimensional
issue.
Socio-economic
and
patient-related
factors
include
low
educational
levels,
inadequate
knowledge
about
dis-
ease
and
medications,
beliefs
about
medications
and
patients’
motivation
to
manage
their
illness
and
improve
their
overall
health
(Broekmans,
Dobbels,
Milisen,
Morlion,
&
Vanderschueren,
2010).
Lack
of
social
support
and
psychological,
cognitive
or
medical
vul-
nerability
can
also
play
a
part
(Kronish
&
Ye,
2013).
Factors
shown
to
predict
medication
non-adherence
include
low
self-efficacy,
atti-
tudes
and
beliefs
about
medications,
low
perceived
behavioural
control,
and
lack
of
social
support
(Morrison
et
al.,
2015).
Patients
with
concerns
about
their
medications
are
more
likely
to
report
for-
getting
to
take
them
or
intentionally
skipping
doses
(World
Health
Organisation,
2003).
Older
people
and
people
in
poor
health
or
with
co-morbidities
are
less
likely
to
successfully
self-administer
(Krueger
et
al.,
2015).
Medication
self-efficacy
and
beliefs
about
medications
may
also
influence
the
adoption
and
maintenance
of
medication
adherence
behaviours
(Bane,
Hughe,
&
McElnay,
2006),
and
these
factors
can
be
affected
by
psycho-social
factors
such
as
the
perceived
level
of
social
support
and
mood
(Cha,
Erlen,
Kim,
Sereika,
&
Caruthers,
2008).
Exploring
patients’
emotions
and
beliefs
while
helping
to
strengthen
their
self-efficacy
may
minimise
barriers
to
behavioural
change
and
motivate
them
to
adhere
to
their
medications
(Riegel,
Masterson
Creber,
Hill,
Chittams,
&
Hoke,
2016).
It
is
important
to
promote
behavioural
change
by
exploring
what
drives
an
individ-
ual
patient
to
make
changes
or
to
maintain
the
status
quo.
This
can
be
achieved
by
applying
motivational
interviewing
techniques
that
have
been
found
to
be
effective
in
assessing
a
patient’s
readiness
to
change
and
subsequently
moving
toward
change
at
an
appropri-
ate
time
(Dart,
2010).
Motivational
interviewing
has
been
shown
to
be
effective
in
increasing
medication
adherence
in
cardiac
patients
(Ogedegbe
et
al.,
2008).
Also,
text
messages
have
been
effective
in
improving
the
use
of
prescribed
cardiac
medications
among
65%
of
patients
at
six
months
(Wald,
Bestwick,
Raiman,
Brendell,
&
Wald,
2014).
Understanding
the
reasons
for
poor
adherence
may
suggest
approaches
to
novel
interventions.
3.
Theoretical
framework
guiding
the
study
This
study
will
use
Bandura’s
social
cognitive
theory
to
enhance
the
refinement
of
self-efficacy
(Bandura,
1977)
and
to
examine
the
effects
of
individual,
behavioural
and
environmental
factors
on
medication
adherence.
According
to
the
theory,
self-efficacy
is
the
pivotal
determinant
in
influencing
a
person’s
particu-
lar
behaviour,
directly
affecting
one’s
actions
and
impacting
on
other
determinants
(Bandura,
1977,
2004).
Bandura
(2004)
notes
that
self-efficacy
determines
the
expected
outcomes
of
people’s
behaviours.
Reciprocal
determinism
is
the
basic
organising
prin-
ciple
of
behaviour
change
proposed
by
this
social
cognitive
theory,
with
continuous,
functional
interaction
between
the
environment,
the
individual
and
behaviour
(Bandura,
1998)
(Fig.
1).
It
assumes
that
a
change
in
knowledge
of
health
risk
and
benefits
is
essen-
tial,
but
requires
additional
impacts
for
change
to
occur
(Munro,
Lewin,
Swart,
&
Volmink,
2007).
Other
determinants
of
behaviour
change
include
behaviours,
outcome
expectations,
expected
ben-
efits,
beliefs
and
goals,
and
perceived
facilitators
and
barriers.
The
theory
proposes
that
if
people
perceive
that
they
have
outcome
control,
appropriate
behaviour
will
follow,
with
sufficiently
high
self-confidence
to
overcome
otherwise
insurmountable
barriers
(Armitage
&
Conner,
2000).
Using
a
theoretical
basis
to
explain
relationships
between
study
variables
is
important
when
designing
effective
behavioural
change
studies
(Short
et
al.,
2013).
Appropriately
designed
interventions
that
employ
multiple
strategies,
such
as
motivational
interview-
ing
to
encourage
behaviour
changes
and
text
messaging
strategies
to
reinforce
behaviours,
are
likely
to
achieve
significant
increases
in
medication
adherence
in
cardiac
patients
(Al-Ganmi,
Perry,
Gholizadeh,
&
Alotaibi,
2016).
4.
Methods
4.1.
Aim
and
hypothesis
The
study
aims
to
use
a
pilot
randomised
controlled
trial
(RCT)
to
test
the
hypothesis
that
a
theory
based,
nurse-led,
multi-faceted
A.H.A.
Al-Ganmi
et
al.
/
Collegian
25
(2018)
385–394
387
Fig.
1.
Synthesized
*social-cognitive
and
**self-efficacy
models
(Bandura,
1998)
guiding
the
intervention
of
this
protocol.
intervention
comprising
motivational
interviewing
techniques
and
text
message
reminders
in
addition
to
standard
care
will
better
promote
medication
adherence
in
cardiac
patients
compared
to
standard
care
alone.
Underpinning
evidence
and
assumptions
of
the
hypothesis
are
that:
1)
A
high
proportion
of
patients
fail
to
adhere
to
their
cardiovascu-
lar
medication
regimens.
2)
Medication
adherence
self-efficacy,
patient
beliefs,
and
lack
of
social
support
are
predictive
factors
associated
with
non-
adher-
ence
to
medication.
3)
High
quality
evidence
supports
the
use
of
multi-faceted
inter-
ventions
comprising
of
motivational
interviewing
counselling
combined
with
text
messaging
reminders
to
promote
med-
ication
adherence.
The
pilot
study
will
assess
self-reported
adherence
or
non-adherence
to
cardiovascular
medication
in
patients
referred
to
a
cardiac
rehabilitation
program
following
hospital
admission
for
an
acute
cardiac
event
and
test
the
fea-
sibility
of
the
intervention.
Medication
non-adherence
has
been
defined
as
‘taking
less
than
80%
of
prescribed
doses
and
can
also
include
taking
too
many
doses’
and
it
is
associated
with
an
increased
risk
of
poor
health,
adverse
clinical
events
and
death
(Nieuwlaat
et
al.,
2014).
The
study
will
examine
the
role
of
individual,
behavioural
and
environmental
factors
in
predicting
medication
non-adherence
in
patients
with
CVD.
4.2.
Study
design
This
is
a
mixed
methods
study
which
includes
a
nested,
pilot
RCT.
Both
qualitative
and
quantitative
methods
are
required
to
address
the
study’s
aims
and
hypothesis.
The
use
of
mixed
methods
is
valuable
to
provide
a
fuller
picture
of
the
topic
and
to
transcend
the
limitations
of
each
of
the
methods
used
singly
(Borkan,
2004;
Creswell,
Fetters,
&
Ivankova,
2004).
In
this
study,
data
collection
will
occur
sequentially:
quanti-
tative
data
collection
followed
by
qualitative
data
collection
will
occur
for
the
exploratory
phases
that
will
provide
the
explana-
tory
power
in
support
of
the
final
(RCT)
intervention
testing
phase:
(QUAN
+
qual)
→
QUAN.
Results
from
the
exploratory
phases
(sur-
vey
design
and
semi-structured
interviews)
will
inform
the
fine
tuning
of
the
intervention
in
the
third
phase.
This
multi-method
study
will
entail
three
interrelated
phases:
Phase
one:
The
survey
is
designed
to
identify
cardiac
patients’
patterns
of
medication
adherence
and
their
associated
degree
of
adherence.
The
purpose
of
the
survey
is
to
gather
quantitative
data
about
medication
adherence,
patient
behaviours,
beliefs
and
other
associated
factors,
including
demographic
data
which
will
inform
intervention
and
form
baseline
data.
Phase
two:
A
descriptive
qualitative
study
will
explore
the
phe-
nomena
of
cardiac
patients’
adherence
to
medications
and
how
they
respond
to
factors
that
affect
medication
adherence.
Using
semi-structured
interviews,
patients’
views
of
their
cardiac
medi-
cations
will
be
explored
as
well
as
the
factors
that
influence
their
medication
adherence.
A
semi-structured
interview
format
was
chosen
because
of
its
flexibility
in
collecting
self-reporting
data
(Cohen
&
Crabtree,
2006),
enabling
participants
to
talk
freely
about
issues
related
to
their
medication
adherence
and
telling
stories
in
their
own
words.
Semi-
structured
in-depth
interviews
will
involve
open-ended
questions
to
elicit
detailed
narratives
and
stories
(Whiting,
2008).
This
will
provide
in-depth
understanding
to
supplement
and
explain
quan-
titative
results
from
Phase
one.
388
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385–394
Fig.
2.
CONSORT
Schematic
of
steps
in
this
protocol.
Details
of
Phase
one
and
Phase
two
data
will
be
used
to
inform
motivational
interviewing
techniques
and
to
tailor
the
interven-
tions
to
individual
patients’
needs
to
better
support
their
adherence
to
cardiac
medications.
Phase
three,
a
pilot
RCT:
Participants
identified
as
non-
adherent
to
their
medications
in
Phase
one
(based
on
Medication
Adherence
Questionnaire
[MAQ]
scores)
and
Phase
two
data
(themes
and
patterns
of
medication
adherence/non-adherence)
will
be
invited
to
take
part
in
this
pilot
trial.
This
will
pilot
test
the
feasibility
and
effectiveness
of
a
multi-faceted
inter-
vention
strategy,
including
motivational
interviews
plus
text
message
reminders,
to
influence
adherence
to
their
cardiac
med-
ication
regimes.
The
RCT
will
test
and
compare
differences
in
outcomes
between
the
standard
care
delivered
by
a
cardiac
reha-
bilitation
program
and
the
same
program
augmented
by
this
multi-faceted
intervention.
The
feasibility
of
conducting
a
multi-
faceted
behavioural
intervention
in
a
busy
cardiac
rehabilitation
setting
will
be
investigated.
We
also
sought
data
to
determine
the
effect
size
for
sample-size
calculation
as
we
could
only
extrapo-
late
an
estimated
effect
size
from
a
somewhat
similar
trial
for
the
sample
size
calculation
of
this
pilot
study.
Data
are
currently
lack-
ing
for
full-scale
trial
of
this
approach
among
cardiac
rehabilitation
patients.
4.3.
Study
setting
and
participants
The
study
will
be
carried
out
in
the
cardiac
rehabilitation
centre
of
a
tertiary
referral
hospital
(Prince
of
Wales
Hospital)
in
Sydney,
Australia.
Participants
will
be
cardiac
patients
referred
to
a
car-
diac
rehabilitation
program
following
their
admission
for
an
acute
cardiac
event;
those
participating
in
the
pilot
trial
will
be
ran-
domly
allocated
to
receive
either
the
intervention
plus
standard
care
or
standard
care
only.
Inclusion
criteria
are:
18
years
of
age
or
older;
diagnosed
with
cardiac
disease
and
referred
to
the
hospital
cardiac
rehabilitation
program;
currently
taking
at
least
one
cardio-
protective
medication,
and
having
primary
responsibility
for
taking
their
own
medications
(i.e.
not
reliant
on
a
carer).
Participants
must
be
able
to
read,
speak
and
understand
English,
have
a
personal
mobile
phone,
and
be
able
to
receive
and
reply
to
phone
calls
and
text
messages.
Patients
who
are
blind,
deaf
or
unable
to
consent
to
receiving
text
messages
will
be
excluded.
Those
clinically
judged
to
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(2018)
385–394
389
have
cognitive
impairment
that
limits
their
ability
to
understand
and
answer
the
study
questions
will
also
be
excluded.
4.4.
Sample
size
determination
The
sample
size
for
the
pilot
RCT
was
based
on
data
from
Ma,
Zhou,
Zhou,
and
Huang
(2014).
Using
a
two-sided
test,
moderate
effect
size
with
␣
=
0.05,
and
power
=
0.80,
nine
participants
are
required
in
each
group.
Allowing
for
50%
loss,
a
total
of
28
cardiac
patients
will
be
needed
for
the
pilot
RCT.
Around
350
patients
per
year
(30
per
month)
are
estimated
to
attend
the
cardiac
rehabilitation
centre.
Pilot
data
indicate
around
one
third
are
considered
non-adherent
to
medications.
If
50%
of
eli-
gible
patients
agree
to
participate,
recruitment
will
progress
at
five
participants
per
month
(a
rate
o
Aims
f
recruitment
easily
man-
ageable
for
the
researcher):
it
will
take
six
months
to
enrol
28
participants,
so
the
study
will
take
approximately
six
months
for
recruitment
and
six
more
months
for
intervention
and
follow-up.
4.5.
Study
procedures
and
data
collection
Data
collection
will
take
place
at
baseline
and
at
six
months,
and
changes
in
medication
adherence
will
be
compared
within
and
between
groups
to
determine
any
intervention
effect.
The
Consolidated
Standard
of
Reporting
Trials
(CONSORT)
diagram
of
study
processes
is
presented
in
Fig.
2.
Baseline
survey
and
inter-
view
data
will
be
collected
during
patients’
hospital
attendance
for
a
cardiac
rehabilitation
session.
Pilot
RCT
participants
will
repeat
the
Phase
one
survey
via
telephone
interview
at
six
months
post-randomisation
to
collect
the
follow-up
data;
three
additional
open-ended
questions
(see
Appendix
A)
will
explore
participants’
experiences
of
the
motivational
interview
and
the
text
messaging,
and
enquire
whether
anything
else
might
have
helped
adherence.
In
Phase
two
each
interview
will
involve
a
face-to-face
meet-
ing
for
an
interview
guided
by
a
set
of
questions
or
topics
(Polit
&
Beck,
2004).
Interviews
will
be
arranged
with
participants
using
preferred
communication
methods
with
reminders
two
days
beforehand.
The
guide
for
the
individual
semi-structured
inter-
views
can
be
found
in
Appendix
B.
Data
collection,
transcription
and
analysis
will
be
conducted,
with
questions
modified
in
light
of
responses
and
emergent
themes
(Braun
&
Clarke,
2006).
4.6.
Recruitment,
enrolment
and
consent
Recruitment
will
occur
under
the
supervision
of
the
clinical
nurse
consultant
for
cardiac
rehabilitation,
with
the
agreement
of
the
director
of
nursing
and
the
cardiology
consultant.
Patients
referred
to
the
cardiac
rehabilitation
program
will
be
screened
using
the
study
inclusion/exclusion
criteria
by
the
clinical
nurse
consultant
at
their
first
session.
Eligible
members
of
a
consecu-
tive
cohort
of
patients
who
express
interest
in
the
project
will
be
referred
to
the
researcher,
who
will
explain
the
study
phases
and
provide
an
information
statement
and
consent
form.
Completion
of
the
survey
will
identify
patients
who
are
non-adherent
with
at
least
one
cardiac
medication,
based
on
their
answers
to
the
MAQ
with
their
non-adherence
confirmed
and
detailed
at
Phase
two
by
semi-
structured
interview.
At
the
conclusion
of
the
semi-structured
interview
(Phase
two),
eligible
participants
will
be
informed
about
Phase
three,
the
pilot
RCT,
and
invited
to
participate.
The
researcher
will
obtain
written
informed
consent
from
par-
ticipants
for
Phases
one
and
two;
similar
consent
to
participate
in
the
pilot
trial
will
be
obtained
separately.
Participants
will
receive
a
folder
at
enrolment,
including
written
information
about
the
study
and
a
copy
of
their
consent
form,
to
supplement
the
face-to-face
explanation
of
the
study.
4.7.
Randomisation
and
blinding
processes
In
the
pilot
RCT,
participants
will
be
randomly
assigned
to
either
intervention
or
control
group
after
they
have
consented
to
the
trial
phase.
A
computerised
random
number
generator
will
be
used
to
generate
the
random
sequence.
Using
permutated
blocks
equal
numbers
of
participants
will
be
assigned
to
each
group.
Sequentially
numbered
sealed
envelopes
will
be
used
to
conceal
the
sequence
until
participants
are
assigned.
Neither
the
participants
nor
the
researcher
can
be
blinded
to
the
group
allocation
because
of
the
nature
of
the
behavioural
intervention.
A
behavioural
inter-
vention
such
as
motivational
interviewing
is
not
easily
delivered
blinded,
and
it
is
unlikely
that
cardiac
patients
in
a
cardiac
reha-
bilitation
program
would
not
know
which
intervention
they
are
receiving
(Page
&
Persch,
2013).
Outcome
data
are
self-reported,
but
the
assessor
who
will
collect
the
outcome
data
will
be
blinded
to
study
allocation
to
reduce
potential
bias.
4.8.
The
study
intervention
Approaches
such
as
motivational
interviewing
aim
to
encour-
age
behaviour
change
through
influencing
individual’s
feelings,
thoughts,
and
confidence
to
change
their
behaviours,
for
exam-
ple:
adhere
to
a
recommended
medical
regimen.
The
technique
facilitates
behaviour
change
by
resolving
patients’
ambivalence
to
change
(Miller
&
Rollnick,
2002).
Motivational
interviewing
has
been
incorporated
into
several
successful
medication
adherence
interventions
(Solomon
et
al.,
2009).
Using
this
technique,
a
wide
variety
of
medication
non-adherence
factors
are
targeted,
enabling
patients
to
reflect
on
perceived
barriers
and
search
for
solutions
(Easthall,
Song,
&
Bhattacharya,
2013).
The
interviewing
‘elicits
a
range
of
possible
actions
and
affirms
the
patient’s
autonomy
to
make
informed
choices’
(Riegel
et
al.,
2016,
p.
3).
Self-efficacy,
one
of
the
targeted
factors,
predicts
adherence
to
medications,
and
this
may
be
mediated
by
patients’
beliefs
about
their
ability
to
cope,
to
locate
optimistic
changes
in
their
social
relations
and
to
improve
their
individual
confidence
(Luszczynska,
Sarkar,
&
Knoll,
2007).
Social
cognitive
theory
has
previously
been
applied
to
examine
medication
adherence
among
CVD
patients
(Haskell
et
al.,
1994),
to
foster
individuals’
medication
adherence
by
setting
goals
and
creating
firm
commitments
to
them,
thereby
encouraging
patients
to
exercise
more
control
over
behaviours.
In
turn
patients
can
come
to
believe
they
have
a
higher
ability
to
adhere
to
their
medications
(Smith,
Rublein,
Marcus,
Brock,
&
Chesney,
2003).
Text
messaging
has
been
widely
used
to
improve
health
behaviours
across
multiple
diseases
(Spoelstra
et
al.,
2015).
It
has
been
used
to
improve
medication
adherence
by
affecting
differ-
ent
elements
of
cognition
and
evoking
attention
and
an
automatic
response
(Yiend,
2010).
Text
Messaging
is
widely
available
low-
cost,
patient
friendly,
requires
low
technological
expertise
and
is
applicable
in
a
diverse
range
of
health
behaviours,
acting
as
a
safety-net
for
medication
reminders
(Cole-Lewis
&
Kershaw,
2010;
Zallman,
Bearse,
West,
Bor,
&
McCormick,
2016).
4.9.
Intervention
arm
Participants
in
the
intervention
group
will
receive
current
standard
care
through
the
cardiac
rehabilitation
program
plus
behavioural
counselling
about
medication
adherence
using
moti-
vational
interviewing
and
text
reminders.
The
current
cardiac
rehabilitation
program
includes
a
single
one-hour
information
ses-
sion
on
cardiac
medication.
The
content
received
by
both
group
participants
will
be
recorded
and
compared
to
check
for
equiva-
lence
between
the
groups.
Each
patient
in
the
intervention
group
will
receive
approx-
imately
30–40
min
of
a
single
motivational
interview-style
390
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(2018)
385–394
Table
1
Examples
of
text
message
reminders.
Example
1
‘Hello
Mr/Mrs.
.
..
.
..
.
..
.
..
Have
you
refilled
your
heart
medication?
Please
text
Y
if
you
refilled
your
medication
before
receiving
this
text,
text
R
if
your
answer
is
the
message
has
reminded
you
and
you
will
refill
your
medication;
text
N
if
your
answer
is
No.
Thank
you.
Example
2
Hello
Mr/Mrs.
.
..
.
..
.
..
.
..
Have
you
taken
your
heart
medication
today?
Please
text
Y
if
you
took
your
medication
before
receiving
this
text,
text
R
if
your
answer
is
the
message
has
reminded
you,
and
you
will
take
your
medication;
text
N
if
your
answer
is
No.
Thank
you.
Example
3
Hello
Mr/Mrs.
.
..
.
..
.
..
.
..
Have
you
arranged
to
take
your
heart
medication
more
than
once
today?
Please
text
Y
if
your
answer
is
you
have
arranged
to
take
your
heart
medication
twice
a
day
before
receiving
this
text;
text
R
if
your
answer
is
the
message
has
reminded
you;
text
N
if
your
answer
is
No.
Thank
you.
counselling
session
(Ma
et
al.,
2014).
The
essence
of
motivational
interviewing
is
for
the
counsellor
to
be
simultaneously
sympa-
thetic
and
supportive,
as
well
as
directive
in
moving
patients
toward
behaviour
change
by
strengthening
their
reasons
to
change
(Levensky,
Forcehimes,
O’Donohue,
&
Beitz,
2007).
As
part
of
the
counselling,
the
researcher
will
provide
information
that
the
patient
may
need,
and
explore
barriers
that
keep
the
patient
from
adhering
to
the
medication
regimen
(Dart,
2010).
A
structured
counselling
script
will
be
designed
that
can
be
tailored
to
medica-
tion
adherence
characteristics
of
individual
patients
(Dart,
2010).
Examples
of
the
content
of
the
session
are
available
in
Appendix
C.
The
sessions
will
be
audiotaped
and
reviewed
by
a
clinician
quali-
fied
in
motivational
interviewing
to
ensure
fidelity
(Ma
et
al.,
2014).
Text
message
reminders
will
be
sent
daily
for
the
first
two
weeks,
then
on
alternate
days
for
fortnight,
then
once
a
week
for
the
next
five
months,
for
a
total
of
six
months
(Wald
et
al.,
2014).
The
content
will
vary
according
to
each
patient’s
non-adherence
factors.
Examples
are
supplied
in
Table
1.
4.10.
Control
arm
For
the
period
of
the
study,
patients
in
the
control
arm
will
be
provided
only
with
current
standard
care,
which
includes
the
pro-
vision
of
cardiac
care
knowledge
and
recommendations
to
enhance
medication
adherence
and
to
promote
healthy
lifestyles;
they
will
complete
the
same
surveys
as
the
intervention
arm
at
baseline
and
at
six
months.
4.11.
Outcomes
The
primary
outcome
is
medication
adherence/non-adherence
at
six
months.
Medication
adherence
will
be
determined
based
on
participants’
responses
to
the
MAQ
(Morisky,
Green,
&
Levine,
1986).
Patients
with
a
sum
score
of
1–2
will
be
considered
‘adher-
ent’;
those
with
a
score
of
3–4
as
‘non-adherent’
(Morisky
et
al.,
1986).
Secondary
outcomes
include
identification
of
those
factors
exerting
a
significant
influence
on
medication
adherence,
such
as
behaviour
(self-regulation),
beliefs
(general
harm;
general
overuse;
specific
necessity;
and
specific
concerns),
social
support
and
self-
efficacy
using
a
combination
of
instruments,
outlined
below.
To
assess
the
acceptability
of
the
intervention
at
six
months,
the
researcher
will
telephone
each
member
of
the
intervention
group
to
evaluate
their
experience
of
the
interview
and
text
messages
(see
Appendix
A).
4.12.
Study
instruments
The
survey
will
include
a
set
of
questionnaires
designed
to
gather
data
about
medication
adherence
and
patient
behaviours,
beliefs
and
other
factors
associated
with
adherence/non-
adherence.
The
survey
will
be
paper
based,
self-administered,
and
suitable
for
participants
with
low
literacy
skills.
Sociode-
mographic
and
health
data
will
be
collected:
age,
gender,
living
arrangement,
level
of
education,
ethnicity;
co-morbidities.
The
use
of
different
instruments
in
this
study
will
enable
comprehensive
study
of
factors
contributing
to
medication
non-
adherence
in
patients
with
CVD,
including
behavioural
and
psychological
factors.
Motivational
interviews
in
the
RCT
phase
will
focus
on
the
identified
non-adherence
factors
for
each
individual
patient.
Medication
non-adherence
will
be
assessed
by
the
Medication
Adherence
Questionnaire
(MAQ)
(Morisky
et
al.,
1986),
which
is
designed
to
measure
medication
adherence
behaviour
and
barriers
such
as
forgetfulness,
carelessness,
adverse
effects
and
efficacy.
It
includes
four
simple
dichotomous
questions,
assigning
one
point
for
each
yes
response;
total
scores
are
categorised
as:
0
=
high;
1–2
=
medium,
and
3–4
=
low
medication
adherence
behaviours
(Morisky
et
al.,
1986).
The
Adherence
to
Refills
and
Medications
Scale
(ARMS)
(Kripalani,
Risser,
Gatti,
&
Jacobson,
2009)
will
be
used
to
determine
medication
adherence
behaviour
in
terms
of
self-regulation.
The
ARMS
is
a
12-item
scale:
an
eight-item
medication-taking
subscale
assessing
correct
self-administration
for
the
prescribed
medica-
tions;
and
a
four-item
prescription
refill
subscale
evaluating
the
patient’s
ability
to
replenish
medications
on
schedule.
Each
item
is
scored
on
a
four-point
scale
ranging
from
l
=
none
of
the
time
to
4
=
all
the
time
on
a
four-point
Likert
scale,
with
higher
num-
bers
demonstrating
better
refill
ability
for
medications
on
schedule
(Kripalani
et
al.,
2009).
The
Belief
about
Medicine
Questionnaire
(BaMQ)
(Horne,
Weinman,
&
Hankins,
1999)
elicits
information
on
patients’
beliefs
about
medications
which
may
be
adherence-related.
It
identifies
whether
the
patient
believes
in
the
necessity
of
their
medicines
or
has
concerns
about
them.
The
study
will
use
the
short
(eight-item)
version
of
the
BaMQ
developed
by
Horne
et
al.
(1999),
composed
of
four
subscales
of
two
items
each,
assessing:
specific
necessity,
spe-
cific
concerns,
general
overuse
and
general
harm.
Answers
range
from
l
=
strongly
disagree
to
5
=
strongly
agree
on
a
five-point
Lik-
ert
scale;
scores
are
summed
to
derive
a
total
score,
with
higher
scores
indicating
more
positive
beliefs.
The
Medication
Adherence
Self-Efficacy
Scale-Revised
(MASESE-R)
(Fernandez,
Chaplin,
Schoenthaler,
&
Ogedegbe,
2008)
consists
of
13
items
that
evaluate
an
individual’s
ability
to
adhere
to
medications
under
various
challenging
circumstances.
Twelve
items
examine
patients’
confidence
in
taking
medications
in
specific
circumstances
(e.g.
with
family,
in
public
places,
feeling
well),
and
one
assess
the
ability
to
take
medications
as
part
of
the
everyday
routine.
Each
item
is
scored
on
a
four-point
Likert
scale,
ranging
from
0
=
not
at
all
sure
to
3
=
extremely
sure.
A
single
score
is
derived
from
the
mean
of
all
items,
with
greater
self-efficacy
indicated
by
high
scores
(Fernandez
et
al.,
2008).
The
Medication
Specific
Social
Support
(MSSS)
scale
(Lehavot
et
al.,
2011)
is
an
eight-item
survey
of
medication-specific
social
support
to
identify
how
often
others
help
patients
with
their
medi-
cation,
scored
for
each
item
ranging
from
0
=
never
to
4
=
very
often.
A
single
mean
score
is
presented
as
a
medication-specific
index
of
support
(Lehavot
et
al.,
2011).
4.13.
Validity
and
reliability
The
MAQ
is
a
validated
four-item
tool
suitable
for
a
wide
range
of
conditions
involving
cardiac
diseases
(Nguyen,
Caze,
&
Cottrell,
2014).
Its
validity
and
reliability
has
been
determined
in
patients
with
hypertension,
with
a
reported
acceptable
internal
consistency
of
␣
=
0.61,
sensitivity
0.81
and
specificity
0.44
(Lavsa,
Holzworth,