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Nadolnyetal. Trials (2023) 24:136
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Trials
Case management andcare expertise
asaprevention approach foradults
withintellectual disabilities (FaPP-MgB): study
protocol forarandomized-controlled trial
Stephan Nadolny1,2* , Dirk Bruland1 , Marie Grunwald1,3, Annika Gröndahl1, Jessica Grammatico1,
Miriam Tariba Richter4, Christian Grebe1† and Änne‑Dörte Latteck1†
Abstract
Background Adults with intellectual disabilities have a higher prevalence of unhealthy eating habits, stress, low lev‑
els of mobility, and comparable drug consumption as the general population. Consequently, they suffer from several
chronic diseases earlier and more often, but there are fewer prevention and health promotion services including this
population. The goal of this study is to determine if an advanced practice nursing approach in the community with
home visits is an effective way to improve the health status of adults with intellectual disabilities.
Methods We will conduct a randomized‑controlled trial with waiting list design in Hamburg, Germany. Inclusion
criteria are diagnosis ICD F70‑F79 and exclusion criteria are care level > 3 according to the German Social Code XI or
being at the end‑of‑life. Participants will be block randomized. The intervention consists of advanced practice nurses
performing case management, social space analysis, prevention planning, and counseling through four outreach
home visits on nutrition, mobility, addiction, and stress. Comparison is usual care. The primary outcome is health sta‑
tus (WHODAS) after 12 months. Secondary outcomes are health‑related quality of life (EQ‑5D) and resilience (RS‑11)
after 6 and 12 months. The calculated sample size is 256 with an estimated dropout of 30%. Raters and analysts will be
blinded. Analysis will be performed using ANCOVAs.
Discussion By providing case management and utilizing their nursing expertise, advanced practice nurses will pro‑
vide valuable input and guidance on prevention and health promotion for people with intellectual disabilities. They
will close the gap between health and social care, which is prominent in Germany, through cooperation between the
existing care sectors.
The findings will be disseminated in peer‑reviewed journals and presented at national and international conferences.
Trial registration German Clinical Trials Register, DRKS0 00287 71, registered 4 July 2022, Universal Trial Number:
U1111‑1277–0595.
Keywords Advanced nursing practice, Nursing, Case management, Prevention, Health promotion, Intellectual
disabilities, Randomized‑controlled trial, Germany
†Christian Grebe and Änne‑Dörte Latteck contributed equally to this work.
*Correspondence:
Stephan Nadolny
stephan.nadolny1@fh‑bielefeld.de
Full list of author information is available at the end of the article
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Page 2 of 9
Nadolnyetal. Trials (2023) 24:136
Introduction
People with intellectual disabilities1 account for approxi-
mately 1% of the population depending on method of
measurement and context [1, 2]. ey have higher risk
of certain (chronic) diseases depending on context, e.g.
asthma, diabetes, epilepsy, obesity, and osteoporosis as
compared to the general population [3, 4, 5]. ey seem
to show high levels of sedentary behavior [6] and low
levels of physical activity [7]. Additionally, people with
intellectual disabilities are more susceptible to unhealthy
eating habits [8] as well as stress [9] throughout their life
and show similar levels of tobacco and alcohol consump-
tion as the general population [10]. However, they seem
to be more vulnerable to the side effects of drug con-
sumption [11]. erefore, they have an elevated mortality
which could have been mitigated by healthcare interven-
tions [12, 13, 14, 15].
As any other group, people with intellectual disabili-
ties could make use of more health services with regard
to prevention and health promotion. However, there are
several factors that, among others, result in lower rates
of received prevention and health promotion interven-
tions [16]. First, programs enrolling people with intellec-
tual disabilities are rare (in Germany) since professionals
often do not have the competence to deal with these cli-
ents. Second, people with intellectual disabilities may
have different communication patterns [17]. ird, due
to a lack of data, we assume that a considerable amount
of people has a lower health literacy like the general
population [18, 19], and therefore, identifying suitable
information regarding the topic of prevention and health
promotion is difficult [20]. Fourth, the presented infor-
mation (written or verbal) is often not understandable
[20]. Fifth, people with intellectual disabilities might also
have lower resilience [21] while facing more adversity
throughout their life than the general population [22].
To address these issues, specialized care and sup-
port systems need to be established, which focus on the
(social) environment as well as individual aspects [23,
24]. is implicates that some form of case management
could be helpful improving the situation for people with
intellectual disabilities. However, the German nursing
context differs from most other countries in terms of
graduation and roles.
e education of the majority of nurses takes place at
vocational (nursing) schools. e opportunity to study
for a primary qualification in nursing only exists for about
18years with a considerable increase around 2010 due
to an initiative for model study programs [25]. eaca-
demic qualification in nursing management, science, and
education exists since the early 1990s [26]. Overall, about
2–3.2% of nurses have an academic qualification, most of
them on a bachelor’s level [27]. Additionally, the German
healthcare system is very physician-centered, especially
with regard to prescriptions of medication and medical
aids or referral to other healthcare practitioners. Conse-
quently, Germany lags significantly behind the interna-
tional developments of nursing care of other countries.
erefore, advanced nursing practice (ANP) is only sel-
domly implemented in Germany. ere are several hospi-
tals using advanced practice nurses (APN) expertise, but
no systematic approach exists in Germany [28]. In the
community setting, it is even more rare. Pilot projects in
Germany most recently successfully implemented school
nurses [29].
In Germany, the profession of nursing does not have
a longstanding tradition in caring for people with intel-
lectual disabilities. is field has mostly been worked by
practitioners from curative education, social work, or
social pedagogy. Only in recent years, in the course of the
reform of the German Teilhabegesetz (Participation Act),
it has been advocated to bring more health profession-
als into this field, as the health problems of this popula-
tion group have not been given sufficient attention. We
believe that APNs will be able to combine the elements
of case management, prevention, health promotion, and
working on the (social) environment to improve the care
and health of people with intellectual disabilities as indi-
cated by a recent systematic review on the role and key
activities of APNs [30]. e project “Case management
and care expertise as a prevention approach for adults
with intellectual disabilities” takes up this demand and
develops a prevention offer for people with intellectual
disabilities from the APN understanding.
Regarding the effectiveness of case management, up
to this date, there still remains only limited evidence
[31, 32, 33, 34, 35, 36]. e effects of case management
are not that easily measured with quantitative studies
alone, because it is a complex intervention often work-
ing between the different sectors of care. Especially the
impact on health outcomes might often be mitigated by
other factors [37]. Nonetheless, it might help to reduce
hospital admissions [31, 33, 34, 35], although there also
exists contrasting evidence [36, 38]. Moreover, it can also
possibly have an impact on self-care and self-manage-
ment as well as the communication between healthcare
professionals and the patients and the caregivers [31].
1 We acknowledge that there are cultural differences in “labeling” the target
population. We chose to call thepopulation people with intellectual disabili-
ties for this study because this comes closest to the term used in the German
Social Code. We are also aware that people from the target population in Ger-
many rather want to be called “people with learning difficulties” However, due
to the adherence to the German Social Code and our funding, we use people
with intellectual disabilities throughout this publication, while using “people
with learning difficulties” in the day-to-day interactions.
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Page 3 of 9
Nadolnyetal. Trials (2023) 24:136
is strongly varies between populations and contexts.
On the other hand, qualitative studies highlight, among
other things, the improvement of access to healthcare as
a door opener through coordination as well as advocacy,
improved understanding of health, continuous care due
to individualized care plans, networking, and emotional
support [39, 40]. Considerable barriers for case manage-
ment are time constraints, lack of willingness to work
interdisciplinary by other health professionals, lack of
training, and confusion regarding the case manager’s role
[40, 41].
With respect to people with intellectual disabilities,
only very few studies have been conducted on case man-
agement itself as an intervention so far [42, 43]. However,
case management is usually a part of nursing itself and
is included in interventions regarding prevention and
health promotion for this population. e existing evi-
dence on the effects of prevention and health promotion
on adults with intellectual disabilities is sparse, although
there are 17 reviews on the topic. Most of them include
only a few studies. e biggest body of evidence exists for
weight management and lifestyle changes with 61 studies
overall [5].
Studies focusing specifically on the population at hand
identified the effectiveness of physical activity interven-
tions on maintaining and improving physical activity.
Additionally, specific exercises might improve the peo-
ple’s gait. However, the effect of interventions of activ-
ity and weight management alone on for example the
BMI or food intake are mixed [5, 44]. e combination
of interventions focusing on activity and nutrition seem
to be more promising [5]. e impact of specific inter-
ventions to reduce substance use in any form or improve
stress levels do not show conclusive results [5, 11, 45].
Our study will provide further insight into nurse-led
case management regarding people with intellectual dis-
abilities and ANP in Germany.
Methods
Objectives
e goal of the study is to (a) test the effectiveness of the
ANP intervention on the health status, resilience, and
quality of life of people with intellectual disabilities, (b)
evaluate the process of the intervention, and (c) perform
a health economic evaluation. Here, we will report on (a)
and (b) only.
Design
e study design is a randomized-controlled trial (RCT)
with waiting list and superiority framework. People being
in the control group (CG) will receive the intervention
after completion of data collection after 12months. It will
be conducted from January 2022 to December 2024. e
study is accompanied by a mixed-methods process evalu-
ation consisting of quantitative structured interviews as
well as qualitative interviews focusing on the process as
well as experiences of different stakeholders (APNs, cli-
ents, caregivers, care providers in the community) as
well as an inclusive research group. In the latter, people
with intellectual disabilities will act as co-researchers and
conceptualize their own part in the evaluation. We will
report on the RCT only, because the conceptualization is
finalized. e flow of participants and data collection is
shown in Table1.
Participants andrandomization
e study will be conducted in all seven districts of Ham-
burg, Germany. erefore, participants can live in the
community setting as well as in more residential care
settings. A list of our cooperation partners can be found
in the trial register. Inclusion criteria are a diagnosis of
ICD-11 F70-F79 and being ≥ 18 years. Exclusion crite-
ria are having a care level > 3 according to the German
Social Code XI (which corresponds to severe impair-
ments of independence or abilities), as well as being at
the end-of-life.
Recruitment started in July 2022. Study participants
are recruited through (a) local information events with a
presentation and room for questions in various contexts,
e.g., in residential institutions caring for people with
intellectual disabilities, residential living groups, hous-
ing associations, cultural street festivals, and (b) mailings
by the German health insurance funds AOK Rheinland/
Hamburg and Mobilkrankenkasse which includes adver-
tisements and a statement of support for the study as well
as contact details of the coordinator for the APNsat the
Evangelische Stiftung Alsterdorf (ESA).
Randomization is going to be conducted with the
R-Package randomizeR [46] with randomly permuted
blocks in size of two, four, or six [47]. e person ran-
domizing the participants at the Bielefeld University of
Applied Sciences (BUAS) is also responsible for schedul-
ing the raters for data collection. She is going to send the
list of randomized pseudonyms to the person doing the
appointment coordination for the APNs at ESA. After-
wards, BUAS will inform the participants and if appli-
cable their legal guardians in the CG and intervention
group (IG) about the result of the randomization and will
make appointments for data collection, while the ESA is
doing calls for scheduling the APN visits. e person at
BUAS is the only person that has access to the randomi-
zation procedure and keeps the list of randomizations
password protected.
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Nadolnyetal. Trials (2023) 24:136
Group assignment will be blinded for raters as well as
the analyst. Participants as well as the APNs cannot be
blinded due to the nature of the intervention. e clients
as well as their caregivers are instructed not to talk about
the intervention before each data collection; however,
it can be expected that some clients may tell the raters
about the APNs visits.
Intervention
Nurses on a master’s level (APN) are supposed to work
as case managers and utilize their advanced nursing
expertise. ey are employed at the ESA for this study.
ey will take on all basic functions of case management:
gatekeeping, brokering, and advocacy [48]. e interven-
tion focuses on prevention and healthcare promotion for
people with intellectual disabilities. It targets four areas
of prevention, because the legally determined guideline
for prevention in Germany identifies these as aspects to
be dealt with in the foreground. Additionally, problems
in this area are quite prevalent in people with intellectual
disabilities:
• Mobility
• Nutrition
• Stress
• Addiction
We do not emphasize the differentiation between pri-
mary, secondary, or tertiary prevention, as the bounda-
ries are sometimes blurred [49].
e intervention consists of four home visits over the
span of 1year by APNs. Prior to the visits, a social space
analysis [50] is carried out for each of the seven Ham-
burg districts by the APNs to map out the existing service
structure and identify gaps or accumulations. is will
serve as a starting point for networking with the service
providers as well as an orientation point for being able to
refer the clients to suitable service providers with regard
to the brokering and gatekeeping element of case man-
agement. Additionally, the analysis shows the need to
conceptualize further consultation interventions, which
have to be offered by the APNs themselves. For each dis-
trict 1–2 APNs will be employed depending on the size of
the population in the respective district.
e first home visits consist of the building of a profes-
sional relationship between the clients, their caregivers,
and the APNs as well as a first screening of existing and
potential health problems and resources. ey are going
to employ biographic interviews to explore important
contextual information [51]. e language level will vary
from basic to advanced depending on the client’s abili-
ties. Rules of cooperation are agreed upon, and organi-
zational and time-related issues are resolved. is is
especially important from a study operations perspective.
Table 1 SPIRIT ‑ Phases of trial and data collection
IG Intervention Group, CGControl Group, HQOLHealth-related quality of life
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Page 5 of 9
Nadolnyetal. Trials (2023) 24:136
Participants in studies can sometimes get confused with
the evaluation part of the study and the interventional
part. It is helpful to explain the different parties and their
roles in the study.
e second visit also takes place within the first month
of participation and consists of a detailed assessment of
health problems based on the InterRAI intellectual dis-
ability assessment [52]. A network map will be drawn to
illustrate the social network of the participants. Further
differentiated assessments will be used on a case-by-case
level. In the aftermath,nursing problems and goals will
be structured according to the ABEDL-model [53], and a
case description will be prepared.
e third visit takes place in the second month and
aims for the development of a prevention plan. In the
prevention plan individual goals, (possible) health prob-
lems, preventive interventions, and actions to improve
health as well as suitable outcomes to measure for eval-
uation will be formulated on the basis of the aforemen-
tioned assessments. e plan will be developed in a joint
work between the client, the primary caregivers, and
the APN. e fourth visit will happen after 1year and is
supposed to serve for the evaluation of the actions from
the prevention plan. Moreover, overarching goals for
the client’s health beyond the project should be defined
together with the clients and their caregivers.
Between the home visits the APNs hold liaison with the
clients via their preferred ways, e.g., telephone, e-mail, or
video conference. Every 2months, the prevention plan
is going to be reviewed and updated if necessary. Since
it is common that people with intellectual disabilities
have problems with enrolling in healthcare programs,
the APNs will exercise brokering and advocacy to sup-
port them in getting the care they need. ey will also
gatekeep on certain interventions, if those interventions
are not primarily needed. e APNs will perform single
person interventions in form of counseling regarding the
four areas of prevention by themselves, e.g., counseling
on stress reduction if there are no suitable interventions
available but will of course focus on brokering to keep it
manageable. After 6months, an individual video will be
sent to the client, which focuses on motivation and resil-
ience to keep the clients on track of their prevention plan
or prompt contacts, if something is not going according
to plan.
e APNs document their work in a standardized doc-
umentation system.
e CG will receive usual care. e topic of preven-
tion and health promotion is not well covered by the
existing practice and therefore we opted not to offer an
active intervention. e APNs will not initiate any inter-
action with participants from the CG. However, because
the APNs are situated right within the seven districts
in offices open to the public, it cannot be excluded that
control patients could receive advice or counseling on
healthcare problems.
To improve adherence to the intervention, detailed
intervention descriptions were developed for each home
visit. However, due to the nature of this communicative,
educational, coordinating complex intervention, a degree
of flexibility is needed to tailor the intervention to the
needs of individuals in this diverse population.
Outcomes anddata collection
Overall, the study consists of six time points (t0 to t5) and
is illustrated in Table1. e outcome evaluation will take
place from t0 to t2 after 12months. e process evalua-
tion will take place at t3 after 13months in the IG. We
chose the additional timepoint, because simultaneous
collection of outcome and process data would have com-
promised the rater’s blinding. e process evaluation in
the waiting list group will take place at t4 after 18months
(6months after receiving the intervention) and t5 after
24months (12months after receiving the intervention).
e process evaluation is conducted with all participants
and their primary caregivers.
e primary outcome of the study is the health status
after 12months (t2) measured with the 36-item WHO-
DAS 2.0 interviewer version [54] (proxy). Secondary out-
comes are:
• Health status after 6 months (t1) measured with
36-item WHODAS 2.0 (proxy)
• Resilience after 6 (t1) and 12 (t2) months measured
with RS-11 [55] (self-assessed)
• Health-related quality of life after 6 (t1) and 12 (t2)
months measured with the EQ5D-VAS [56] (proxy
and self-assessed)
We will use the German version for all outcome
measures.
e raters all have a background in nursing or social
pedagogy. ey will be trained in structured interview-
ing of people with intellectual disabilities as well as
the respective assessments used. A pretest has been
performed.
Data collection for outcome evaluation is planned as
face-to-face interviews based on a questionnaire con-
sisting of the aforementioned outcome measures as well
as date of birth and data collection, sex, living situation,
support through formal or informal care, and the rater’s
assessment of the potential study group assignment of
the participants including justification to check the blind-
ing procedure. Data collection will be conducted in the
participants’ homes or a place of their choice. is can
be, for example, their own flat, a residential living group,
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Page 6 of 9
Nadolnyetal. Trials (2023) 24:136
or a residential facility. A primary caregiver (legal rep-
resentative, family member or professional caregiver) is
going to be present for the evaluation of the health status
as well as the quality of life. is usually has the benefi-
cial side effect that many participants feel more comfort-
able with their caregivers present and they can help them
in clarifying questions, because they are familiar with
their context, e.g., if you want to know whether the per-
son is able to walk one kilometer the concept of 1km is
sometimes difficult to grasp. It is easier, if a caregiver can
give an example of something that is as far away, e.g., a
supermarket.
Data collection for the process evaluation is also
planned as face-to-face interviews and is directed
towards the clients as well as their primary caregivers.
e questionnaire comprises of questions on the num-
ber of contacts, quality of communication between the
APN and clients and caregivers, quality of collaboration,
the professional relationship, satisfaction with the inter-
vention, if new knowledge has been gained through the
intervention on stress, mobility, nutrition, and addiction,
and finally potential for improvement of the intervention.
In our previous study on medication management of
people with intellectual disabilities, it has proven useful
to first ask dichotomous questions, e.g., “were you satis-
fied with the caregivers?” and then to ask on an ordinal
scale how (un-)satisfied they were. We will employ this
approach throughout the questionnaire.
We will promote participant retention through several
steps:
1. Personal telephone contact with participants for
scheduling data collection and intervention visits
2. Data collection reminders a week before data collec-
tion via cell phone text service
3. Intervention reminders a week before the visit via cell
phone text service
4. Possibility of short-term appointment postpone-
ments (if within the time frame of data collection and
intervention)
We will not collect any further outcome data from the
individuals after study dropout. After discontinuation of
the intervention, e.g., due to the participant’s request, we
will continue to collect all outcome data up to t3.
Data processing andanalysis
Data will be transferred from the questionnaires to a
prespecified data matrix in IBM SPSS Version 27 by two
raters simultaneously based on a codebook of variables
and their values. Data will be checked periodically by the
project lead on double entries, wrong values, and missing
questionnaires throughout the process to ensure data
quality.
All outcomes can be analyzed with methods for contin-
uous outcomes. We will perform an ANCOVA with the
respective outcome at the respective time point (t1, t2) as
the dependent variable and the baseline value (t0) as the
covariate. We are going to test three hypotheses with a
Bonferroni adjusted alpha of 0.025 each:
e IG differs from the CG regarding:
1. e health status
2. e health-related quality of life
3. Resilience
We will use intention-to-treat analysis for people drop-
ping out of the study, if we have any data on them as well
as participants discontinuing the intervention.
e process evaluation will be analyzed with descrip-
tive statistics, reporting absolute and relative frequencies
as well as measures of central tendency and dispersion
suitable for the respective data level of the items.
Sample size calculation has been performed with the
software G*power 3.1 [57]. Based on an effect size of
f = 0.23 for an ANCOVA, a significance level of 0.05 with
Bonferroni correction to 0.025, and a power of 0.8, 184
participants have to be recruited. As a conservative deci-
sion, we estimated a 30% dropout rate due to the com-
plexity of the intervention and the 1-year time frame as
well as the specifics of the target population. erefore,
we plan to include 256 people with intellectual disabili-
ties (128 per group) in this study.
Validity andreliability
To ensure data quality, we will hold regular appointments
to discuss the process of data collection and problems
during its process. We have developed a data collection
manual with detailed explanation of every question in the
assessments and phrasings that should explicitly not be
used, because they could compromise the assessment.
No external data audit is planned.
Regarding the intervention, the coordinators of the
APNs will supervise them and also hold regular meetings
to ensure process quality of the intervention and help in
dissolving barriers. Especially in the beginning phase of
the intervention, problems will inevitably come up. Since
the APNs are all beginners in their new role, we believe
some guidance is warranted.
Ethics anddissemination
We do not expect any adverse health outcomes during
this study, which are directly related to the interven-
tion. Possibly, participants might feel stressed by the
intervention and data collection. erefore, we evaluate
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Page 7 of 9
Nadolnyetal. Trials (2023) 24:136
ongoing consent at every personal contact with the
study or practice team. We will seek consultation with
the primary caregivers in case we have the impression
that something is awry, e.g., the participant does not
want to participate anymore, but is too polite or hesi-
tant to voice his feelings. Consequently, criteria for dis-
continuing the intervention are participants’ request
or worsening of condition. We will further document
reasons for dropping out of the study and inspect every
case individually for relation to any harms. Addition-
ally, the APNs are encouraged to report any adverse
outcomes or errors related to their practice. After each
case, the project lead will decide upon a continuation
of the study. Since there is no anticipated harm, there is
no compensation for trial participation.
ere will be no formal data monitoring committee;
however, we will present our data at the bi-yearly meet-
ings of the project advisory board, which comprises of
independent experts.
All physical data will be stored in a lockable cabi-
net in a lockable office. The consent forms will be
archived separately. The electronic data will be
stored in a password protected folder. Only the
study personnel has access to this folder. The refer-
ence list with pseudonyms and plain names is stored
separately by the person performing the randomiza-
tion at BUAS.
e findings will be disseminated in peer-reviewed
journals and presented at national and international
conferences relevant to the subject fields.
Roles andresponsibilities
is is an investigator-sponsored study. Hamburg
University of Applied Sciences (HUAS) is the primary
sponsor with project lead Prof. Dr. Miriam Tariba Rich-
ter: MiriamTariba.Richter@haw-hamburg.de. e pri-
mary sponsor is part of the study team as consortium
lead and therefore responsible for the coordination and
management of the project. Recruitment of partici-
pants is the responsibility of the ESA with support by
HUAS. Data collection and analysis will be performed
at the BUAS. e economic analysis is carried out by
the German Hospital Institute. Intervention delivery is
carried out by the ESA. An independent advisory board
consisting of experts from science, politics, profes-
sional practice, and the target group is going to oversee
the project in two meetings each year.
Plans forcommunicating important protocol amendments
torelevant parties
Any modifications to the protocol that could affect the
conduct of the study and the potential benefit to partici-
pants or affect participant safety, including changes in
study objectives, study design, population, sample size,
study procedures, or significant administrative aspects,
will require a formal amendment to the protocol. We will
report important changes to the protocol to the funder
and need its approval as well as that of the ethics com-
mittee. In addition, the details in the German Clinical
Trials Register will be revised accordingly.
Discussion
Germany is significantly behind regarding international
developments of nursing care especially in ANP. Here,
distortions in the execution of the intervention may
occur. For example, it will be a challenge to operate in the
field of prevention and health promotion in Germany.
ere are a lot of barriers with regard to interprofessional
collaboration due to the not well-known field of ANP.
ey need to show determination and perseverance to
influence existing structures. Additionally, in many cases,
the APNs will have to exercise a lot of advocacy to get
people into existing programs.
e COVID-19 pandemic could interfere with the trial
process. If there is another peak of the pandemic in late
fall or winter, it could be difficult to carry out both home
visits and data collection, especially for people living in
institutions. Appropriate digital fallback options will be
provided for this.
Limitations
is study is only performed in the city of Hamburg.
erefore, we cannot exclude that especially in the more
rural areas of Germany the intervention might be more
difficult to perform. However, we believe that it should
also work in other areas than Hamburg, since there might
be even more need for case management and nursing
expertise, because there is less availability of healthcare
professionals in general.
Due to prior experiences with recruitment, we did
not opt for a cluster-randomized trial. It is quite diffi-
cult to recruit a sufficient number of participants from
one, e.g., institution to fill suitable clusters. erefore,
we cannot exclude possible effects of the institution on
the outcomes. As mentioned before, there are no suit-
able assessments for health literacy for this specific topic
and population and therefore we opted not to measure
it with an objective outcome measure. We will measure
elements of knowledge via the process evaluation in the
waiting group, though.
Trial status
is is protocol version 1.4. e first participant was
recruited on 1 September 2022. Recruitment will be con-
cluded in January 2023. e study will be completed in
December 2024.
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 8 of 9
Nadolnyetal. Trials (2023) 24:136
Abbreviations
ANCOVA Analysis of covariance
ANP Advanced nursing practice
APN Advanced practice nurse
BUAS Bielefeld University of Applied Sciences
CG Control group
ESA Evangelische Stiftung Alsterdorf
HUAS Hamburg University of Applied Sciences
IG Intervention group
RCT Randomized‑controlled trial
Acknowledgements
We thank Julia Golletz for her work in the preparation phase of the study.
Authors’ contributions
Conceptualization: ÄDL, CG, MTR; methodology: CG; funding acquisition: ÄDL,
CG, MTR; project administration: ÄDL, CG, DB, MTR; supervision: ÄDL CG, MTR;
writing—original draft: SN; writing—review and editing: All. All authors read
and approved the final manuscript.
Funding
Open Access funding enabled and organized by Deutsche Forschungsge‑
meinschaft (DFG, German Research Foundation) – 490988677 – and Bielefeld
University of Applied Sciences through Projekt DEAL. This work was supported
by a grant from the German Federal Joint Committee (G‑BA) [NVF1_2018‑113].
The views expressed are those of the authors and not necessarily those of the
funders. The funding body has no influence on the design, data collection,
management, analysis, and interpretation of data as well as writing of this
article or decision to submit it for publication.
Availability of data and materials
The datasets analyzed during the current study and statistical codes will be
available from the corresponding author on reasonable request, as is the full
protocol.
Declarations
Ethics approval and consent to participate
Approval was given by the Hamburg University of Applied Sciences’ ethics
committee (No. 2022–10—21 June 2022). Information will be given verbally
and written to the people with intellectual disabilities and, if applicable, their
legal guardians by the APNs. Written, informed consent will be obtained by
the APNs from the study participant and, if applicable, the legal guardian.
Ongoing consent can be revoked at any time during the study.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Author details
1 Institute for Educational and Health‑Care Research in the Health Sector, Biele‑
feld University of Applied Sciences, Interaktion 1, 33619 Bielefeld, Germany.
2 Institute for History and Ethics of Medicine, Interdisciplinary Center for Health
Sciences, Martin Luther University Halle‑Wittenberg, Magdeburger Str. 8,
06112 Halle, Germany. 3 Institute for Management and Technology, Osnabrück
University of Applied Sciences, Kaiserstraße 10C, 49809 Lingen, Germany.
4 Competence Center for Health, Hamburg University of Applied Sciences,
Alexanderstraße 1, 20099 Hamburg, Germany.
Received: 29 November 2022 Accepted: 10 February 2023
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