Protocol

Effect of a tailored multidimensional
intervention on the care burden amongfamily caregivers of stroke survivors: study
protocol for a randomised controlled trial
Mahmoud Ahmed Elsheikh ‍ ‍,1,2 Michiko Moriyama,1 Md Moshiur Rahman ‍ ‍,1
Mayumi Kako,1 Ahmed Hashem El-­Monshed ‍ ‍,3 Mohamed Zoromba ‍ ‍,3
Hamada Zehry,4 Maha Hazem Khalil,5 Mostafa Amr6

To cite: Elsheikh MA,
Moriyama M, Rahman MM,
et al. Effect of a tailoredmultidimensional intervention on
the care burden among family
caregivers of stroke survivors:
study protocol for a randomised
controlled trial. BMJ Open
2020;10:e041637. doi:10.1136/
bmjopen-2020-041637►► Prepublication history forthis paper is available online.
To view these files, please visit
the journal online (http://​dx.​doi.​org/1​ 0.​1136/b​ mjopen-​2020-​
041637).

Received 13 June 2020
Revised 10 November 2020
Accepted 22 November 2020

© Author(s) (or theiremployer(s)) 2020. Re-­use
permitted under CC BY-­NC. No
commercial re-­use. See rights
and permissions. Published by
BMJ.
For numbered affiliations see
end of article.
Correspondence to
Mahmoud Ahmed Elsheikh;d​ 194332@​hiroshima-​u.​ac.​jp

ABSTRACTIntroduction Caring for stroke survivors creates highlevels of care burden among family caregivers. Previous
initiatives at alleviating the care burden have been
unsuccessful. The proposed study aims to evaluate theeffect of a tailored multidimensional intervention on thecare burden among family caregivers of stroke survivors.
Based on the perceived needs of family caregivers, thisintervention takes into account scientific recommendations
to combine three different approaches: skill-­building,
psychoeducation and peer support.
Methods and analysis Using a prospective, randomised,open-­label, parallel-­group design, 110 family caregivers
will be enrolled from Dakahlia Governorate, Egypt between
December 2019 and May 2020, and randomly assigned
to either the intervention group or the control group. The
tailored multidimensional intervention will be administeredfor 6 months, including three home visits, six home-­based
telephone calls and one peer support session. The primary
outcome is the care burden as measured using the Zarit
Burden Interview. Secondary outcomes include changes
in the family caregivers’ perceived needs (Family Needs
Questionnaire-­Revised), coping strategies (Brief-­Coping
Orientation to Problems Experienced) and quality of life
(WHO Quality of Life-­BREF). Outcomes evaluation will be
conducted at baseline (T0), month 3 (T1) and month 6(T2). Independent t-­test will be performed to compare themean values of study variables between the two groups at
both T1 and T2. After adjusting for confounding variables,
analysis of covariance will be used to assess the effect of
the intervention. In addition, repeated measures analysis
of variance will be conducted to assess changes in effectover time.
Ethics and dissemination This study was approved by
the Research Ethics Committee of the Faculty of Nursing,
Mansoura University, Mansoura, Egypt (P.0195). The results
will be published in a scientific peer-­reviewed journal, andfindings will be disseminated at the local and international
levels.
Trial registration number NCT04211662.

INTRODUCTION
Stroke is one of the leading causes of severe
long-­
term disability worldwide,1 ranking

Strengths and limitations of this study►► The tailored multidimensional intervention has been

conceptualised based on evidence-­based practiceand recommendations.
►► The intervention was designed and validated by aninterdisciplinary team of nurses and physicians fromdifferent specialties based on the feasibility of theintervention and the implementation process.
►► The evidence gained from this study will add to theknowledge base for nursing and medical practiceon how to support family caregivers of stroke survivors and reduce their care burden through targetedinterventions.
►► Bias is anticipated in estimating the effects of theintervention due to the unblinded outcomes’ assessment and the open-­label study design.
►► The depressed family caregivers were not planned
to be excluded at the recruitment point which may
affect the results.

third as a cause in industrialised countries
and second in developing countries.2–5
Stroke-­related physical and cognitive disabilities require daily assistance for stroke survivors.6 7 The family caregiver is the person who
helps the stroke survivor carry out all basic
and instrumental activities of daily living.8 9Caregivers play a key role in maintaining thecontinuity of the stroke survivors’ care andrehabilitation.10
Caregiving role can be a valuable andworthwhile effort.11 However, stroke is an
unexpected illness that forces families tocare for their loved ones even when unprepared. It therefore poses many challenges towhich family caregivers are required to adjust
without sacrificing their personal lives.2 8 12
For instance, caregivers of stroke survivors
frequently complain that they get insufficient time for sleep, socialisation and mental
being
relaxation, which affects their well-­Elsheikh MA, et al. BMJ Open 2020;10:e041637. doi:10.1136/bmjopen-2020-041637

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Open accessand health.8 13 14 Besides, caregiving for stroke survivors may also affect the caregivers’ working lives, as it iscommonly associated with restrictions on working time,
regular breaks or quitting.8 Moreover, it affects the relationship between caregivers and other family members.15
Therefore, caregiving for stroke survivors brings physical,
psychological, social and financial burdens that leads toan imbalance between the personal lives of caregivers andtheir caregiving functions.8 16–21 This is likely to negatively
affect all aspects of the caregivers’ quality of life (QoL),22
which, in effect, contributes to a higher care burden.23 24
Furthermore, the care burden experienced by caregiversof stroke survivors may interfere with the rehabilitation of
stroke survivors.25
Family caregivers of stroke survivors frequently
feel insufficiently supported.26–28 Several studies haveaddressed the development and evaluation of interventions aimed at preparing family caregivers to fulfil theircaregiving role and at the same time, reduce the careburden. However, the studies on the effectiveness of pastinterventions have reported contradictory and inconsistent outcomes, mainly related to the design and deliveryof the interventions.29–31
Systematic reviews reveal debate regarding how best
to support the family caregivers of stroke survivors.32–34
Empirical evidence shows that feasible interventions thatare tailored to perceived caregiver needs and concerns
are more successful than rigid interventions that assume
that all caregivers experience the same needs.30 35 36
Previous studies have shown that tailored interventions
have a significant impact on outcomes among caregivers of stroke survivors,18 because these are perceived
to reduce the severity of the care burden as experienced
by caregivers.10 37 Besides, the approach of the current
studies is directed at adopting the interventions that arematched to caregivers’ needs and priorities.38
The literature shows that interventions based on psychoeducational approaches yield better results than thosethat use a pure education approach, which is mostly information providing.39–41 The psychoeducational approachhas positive outcomes, as it focuses on building the family
caregivers’ abilities in specific areas such as the communication skills and coping strategies to empower them tomanage the psychological issues they face. This approachensures the active application of general information to
the specific situation of each caregiver.42 Interventions
designed using only a purely educational approach are
based on the assumption that caregivers will express new
behaviour or change when they are given new information. Although the provision of information is significantly
related to the acquisition of knowledge among caregivers,a lack of information is not the key risk factor for thehigh care burden, and it has no effect on their psychological status.17 18 Moreover, some studies have shownthat using psychoeducational strategies alone has had
significant caregiver outcomes, most of these outcomessuggest that while psychoeducational strategies may leadto an increase in knowledge or satisfaction, they do not

improve other important psychosocial outcomes among
caregivers.41 Some researchers have even suggested thatthe psychoeducational approach has negative impacts on
caregivers, by worsening social adjustment and reducing
satisfaction.29
Conversely, interventions that adopted skill-­building
strategies such as problem-­solving, stress management
and goal setting were successful, resulting in significant
improvements in family caregiver outcomes, including
reduced care burden and depression, and enhanced
competence and caring role. It is well known that theskill-­building approach is effective. The literature indicates studies that incorporate skill-­building to psychoeducational strategies tend to be much more effectiveat improving caregiver outcomes than psychoeducation
alone.29 43 44 Both skill-­building and psychoeducation
could endow caregivers with the skills required for stroke-­
related care, strategies to manage their personal lives andtheir caregiving role,41 and methods for controlling negative thoughts and emotions.45
The literature also highlights a third approach: peer
support. Peer support is crucial in the context of caregiving, as it provides experience-­based knowledge rather
than structured training.46 47 Peers are also likely to feel
more encouraged by sharing their knowledge and experiences to address caregiving difficulties among caregiversof stroke survivors.48 Studies on interventions that use thepeer support approach show positive outcomes among
caregivers. However, systematic reviews have reported
that interventions involving peer support alone are lesssignificant than interventions that incorporate both skill-­building and psychoeducation.29 Besides, the number ofpeer support interventions are limited due to the difficulty in organising peer support groups.49
In summary, while it is fair to assume that interventions
using a single approach or strategy would be of somebenefit to family caregivers of stroke survivors, it is clear
the evidence in favour of this is not enough to recommend such interventions. Therefore, the current study
suggests that the integration of different approaches,such as skill-­building, psychoeducation and peer support,
is likely to have a more positive effect on the care burden
among caregivers of stroke survivors, as they can together
offset the multiple stressors experienced by caregivers.
However, literature related to studies on combined
approach interventions is lacking, and little is known
about their level of effectiveness in various settings. For
instance, in Egypt, where there is no support system
for family caregivers of stroke survivors, the effectiveness of this type of intervention remains unexplored.
Stroke survivors in Egypt are immediately discharged
from acute hospitals to their homes after treating acutesigns and symptoms without any rehabilitation. There
are also no specialised nursing and residential homes
or home-­visiting programmes.50–52 In other words, families are forced to take full responsibility for caring fortheir stroke-­affected family members. This situation
exposes caregivers in Egypt to a heightened risk of care

2Elsheikh MA, et al. BMJ Open 2020;10:e041637. doi:10.1136/bmjopen-2020-041637

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Open accessburden.53 Moreover, the previous studies reveal caregivers in the developed countries where rehabilitationand home healthcare are well-­provided, often feel careburden.12 15 54 55 It was recommended that the caregiversof stroke survivors be supported by providing community-­
integrated interventions which consider the continuous
support after the stroke survivors’ discharge.56 57 Therefore, the results of this study may be also adapted to thosedeveloped countries.
Aim and hypothesis
The proposed study aims to evaluate the effect of a
tailored multidimensional intervention on the careburden among family caregivers of stroke survivors. The
main hypothesis is that the family caregivers of stroke

Figure 1

survivors who receive the tailored multidimensional intervention will perceive a reduced care burden comparedwith family caregivers who receive a simple educational
booklet (control group/CG).
METHODS AND ANALYSIS
Trial design
The study design is a prospective, open-­label, two-­arm,
randomised controlled trial (RCT). All stages of the RCT
have been designed in accordance with the Consolidate
Standards of Reporting Trials (CONSORT)58 and theStandard Protocol Items Recommendations for Interventional Trials.59 Figure 1 gives the study flow chart. The
full record is available online at https://​clinicaltrials.​

Study flow chart.

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Open accessgov/​ct2/​show/​NCT04211662. The trial was started on
27 December 2019, and it is anticipated that the last
follow-­up will be completed by November 2020.
Setting
The proposed study is conducted in Dakahlia Governorate(area: 3471 km2, population: 6 million) which is locatedin the northeastern sector of the Nile Delta, Egypt, andincludes 18 cities.60 Study participants are recruited fromoutpatient clinics, located in Mansoura City, the capitalof Dakahlia Governorate, and surrounding cities locatedwithin a radius of 30 km from the capital city.

of dementia (Mini-­Mental State Examination ≤20 or morethan 20).68 69 Randomisation is performed by a trained
research assistant at the randomised allocation centre
who is not involved in the intervention. The research
assistant then informs the researchers which participants
have been assigned to the IG or the CG.
Patient and public involvement
There was no patient, carer and public involvement indesigning the intervention of the study.

Allocation and randomisation
In this study, a 1:1 open-­label randomisation is used toassign participants to the intervention group (IG) or
the CG. Participants are randomised into one of thetwo groups after stratifying stroke survivors according todependency level (mRS 3 or 4 or 5)23 66 67 and by degree

Intervention
General description
According to the proposed conceptual framework of thisstudy, the intervention is intended to reduce the severityof the care burden, and is designed to reduce family caregivers' perceived unmet needs using psychoeducation,
skill-­building and peer support approaches.16 29 70 Psychoeducation emphasises (1) imparting information on stroke
and its consequences on the stroke survivors physically,
cognitively, emotionally and behaviourally; (2) providing
guidelines for prevention of the stroke recurrence andthe complications after stroke; (3) discussing caregivers'
own emotions and thoughts regarding their current roles
and future responsibilities; and (4) enhancing caregivers'
own coping strategies and stress management skills. Skill-­building is defined in this context as training caregivers
on training on posiin the following skills: (1) hands-­
tioning, transferring and mobility techniques, assistancein activities of daily living; (2) managing stroke survivor’s
emotions and behaviours and impaired cognitive functions; (3) communicating with healthcare professionals
and participating in stroke survivor’s management; (4)improving effective communication strategies with others
to strengthen the social support network and (5) maintaining caregivers’ own healthcare needs. Peer support
is described in this context as offering caregivers theopportunity to share their individual experiences ofcaring for stroke survivors with someone who has gone
through the same experience. Peer support sessions
focus on (1) recognising caregiver’s roles; (2) sharing
the positive aspects of caring; and (3) addressing caregiving challenges and how these can be managed.29 43 44
An intervention plan will be tailored for each caregiver
based on these three approaches (psychoeducation, skill-­building and peer support) which shows the contents ofthe proposed intervention.
The intervention is meant to meet the caregivers'
perceived needs and foster improvements in their coping
mechanisms. It is assumed that the positive impact of theintervention on caregivers' coping strategies and theirperception of the degree to which their needs are met
will lead to an improvement in their QoL and reductionof the care burden; we hypothesised that coping strategies71–73 and perceived needs of caregivers63 74–76 are thevariables mediating between the intervention, QoL andthe care burden of caregivers. Finally, the current study

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Study participants and eligibility criteria
Study participants are family caregivers of stroke survivors. The family caregiver is defined as the primary careprovider for a stroke survivor. The caregiver may be ason, a daughter, a parent, a spouse, daughter-­in-­law, son-­in-­law or other relatives. Caregivers who meet all of thefollowing criteria are included: (1) age 18 years or older,(2) caring for a stroke survivor having a stroke within 6months61–63 with modified Rankin Scale (mRS) scores
equal 3–5 at the enrolment.64 Caregivers are excluded
if stroke survivor has one of the following conditions:(1) other mobility restrictions such as fracture, dislocation, spinal cord injury, spinal vertebrae injury, and (2)terminal-­stage disease such as cancer, liver disease, andkidney disease or any other diseases. Caregivers who havecognitive impairment are excluded from the study.
Recruitment procedure, obtaining consent and checking theeligibility
Difficulty in recruiting appropriate study participants is
one of the potential limitations of any community-­based
study.65 In the current study, participants are therefore approached by physicians and nurses at outpatient
clinics. First, the researchers contact physicians andnurses, explain to them the aim of the study and ask themto inform family caregivers of stroke survivors about the
study. The physicians and nurses inform researchers about
those caregivers who are interested in participating in the
study, and share their contact details with the permission of the caregivers. The researchers then contact the
caregivers to explain to them the purpose of the study.
Caregivers who agree to participate are asked to provide
written informed consent. Data related to stroke survivors
are collected, and as part of the research is conducted via
home visits where the patient lives, written consent fromstroke survivors is also required. The eligibility criteria are
confirmed by the researchers through interviewing the
caregivers, observing the stroke survivors and checking
the medical records.

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Open accesshypothesises that an improvement in the QoL would
reduce the level of perceived care burden.77–79
Designing a tailored multidimensional intervention
To ensure feasibility of the intervention and the implementation process,80 81 the intervention was designedby an interdisciplinary team including nine academic
researchers from different specialties (experts in thefields of neurology, psychiatry, family health, chronic care,
community health and public health), as well as eightintervention nurses with a bachelor’s degree in nursing
and with work experience in hospital stroke units.
The designing process for each family caregiver in
the intervention involved the following five subsequent
steps: (1) intervention nurses assess the caregiver’s needs
using the Family Needs Questionnaire-­
Revised (FNQ-­
R),82 which is used to collect data on each caregiver’s
unique perceived needs in caring for a family member
with stroke.37 83 84 The FNQ-­R enables the creation ofindividualised interventions tailored to each caregiver’s
stated needs. Furthermore, using FNQ-­R before and after
the intervention helps in assessing the effectiveness of
the intervention84; (2) caregiver’s needs are reviewed,
identified and summarised by the interdisciplinary team;(3) telephone interviews between the intervention nurse
and the caregiver are held to prioritise the summarisedneeds85; (4) the interdisciplinary team then creates anintervention plan based on the summarised needs inline with the appropriate skill-­building and psychoeducation strategies likely to fulfil the needs identified. A peer
support session is included in the intervention plan as an
essential strategy; and (5) the intervention plan is sharedwith the caregiver to ensure participant collaboration.85
Intervention delivery
The proposed intervention is administered by the intervention nurses. Interventions that are delivered using
multiple modes (eg, in person, by phone and via peers)
are expected to provide strong evidence of improved
outcomes in family caregivers.29 42 73 86 87 The current
intervention will be delivered using the various modes for6 months. Figure 2 describes an overview of the intervention contents and schedule.

eight intervention nurses will be provided continuous
mentoring and follow-­up through monthly meetings ofthe interdisciplinary team to discuss the progress of theintervention. In addition, the researchers periodicallycheck the plans and the notes documented by the nurses
about perceived caregiver needs and the achievements ofthe supportive intervention, and address newly reported
needs if applicable. Moreover, if there were any risks,
adverse events, or limitations of the intervention andstudy will be documented. In addition, the caregivers
were asked to report negative psychological symptoms ifthey feel during the study period. Those family caregivers
will be referred to the specialists accordingly.
Control group
The CG is provided a simple educational booklet withinformation on stroke and caregiving to stroke survivors,
and these are explained to them during a single home
visit by the intervention nurses. CG family caregivers do
not receive tailored multidimensional interventions.
Data collection and outcomes
Table 1 shows a summary of expected study outcomes,
measurement instruments and time points. Outcomes
will be assessed after the randomisation and prior to thestart of the intervention (T0), 3 months after the start ofthe intervention (T1) and 6 months after the baseline
assessment (T2). The data at three time points will becollected by the intervention nurses without blindness
through visiting the caregivers’ homes.
Primary outcome
Care burden
The primary outcome of this study is the care burden
to be measured using the short version of Zarit BurdenInterview (ZBI).88 The ZBI was adapted and validated for
Arabic language settings (Cronbach’s alpha: 0.77),89 andhas been used in the past to measure the family caregiver’s burden of caring for stroke survivors.17 22 37 67 77 90–93
It addresses the personal strain and role strain aspects.
It can be self-­administered or administered by an interviewer. The tool consists of 12 questions. Items are rated
on a 5-­point Likert scale from 0 (never) to 4 (almost
always), with higher scores representing a greater senseof burden (range 0–48).

Training of intervention nurses and quality control
The intervention nurses underwent a 4-­
week training
programme (31 hours) before the start of the study.
Training was delivered using various methods: face-­to-­face and video lectures, role-­plays, demonstrations andredemonstrations, and group discussions. Training was
imparted on the following topics: family assessment andintervention models, family caregivers and their roles,
effective communication skills, effective motivation skills,
principles of home visiting and home-­based telephone
calling, principles of peer support sessions, data collection and using instruments, and designing an action planwith shared goals. In addition, nurses were taught how
to deliver know-­how and skills to family caregivers. The

Secondary outcomes
Perceived family caregiver needs
Perceived family caregiver needs are measured using
the FNQ-­R, developed by Serio et al.82 The self-­reportquestionnaire consists of six factors (37 items): healthinformation, instrumental support, community support
network, emotional support, professional support andinvolvement with care.82 84 The tool was translated into
Arabic and the validity and reliability will be ensured inthis study. The respondent is asked to choose one of threechoices ‘Y’, ‘P’ or ‘N’ to indicate whether each need has
been met, partially met or not met, respectively. The sumof the number of similar responses within each domain

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Open accessFigure 2

Overview of the intervention contents and schedule.

indicates the extent to which the needs have been met.
For example, the sum of the number of ‘Y’ responses
within each domain indicates the number of needs met.
The total of needs met can be computed by adding all‘Y’ responses from within each of the six domains. To
quantify the proportion of needs rated as met for each
subscale, the proportion will be converted to a 10-­point

Table 1 Study outcomes, measurement instruments and time points
Time points
Outcomes and measurement instruments

T0 (Baseline)

T1 (Month 3)

T2 (Month 6)

Primary outcome:- Care burden (Zarit Burden Interview, ZBI)

√

√

√*

- Family caregivers’ perceived needs (Family
Needs Questionnaire-­Revised, FNQ-­R)

√

√

√

- Coping strategies (Coping Orientation to
Problems Experienced, Brief-­COPE)- Quality of life (WHO Quality of Life-­BREF)

√

√

√

√

√

√

Secondary outcomes:*Primary outcome (care burden (ZBI)) at 6 months.

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Open access

scale (with 0 indicating ‘no needs met’ and 10 indicating‘all needs met’).
Coping strategies
Coping strategies are measured using the Brief-­
COPE(Coping Orientation to Problems Experienced) Inventory developed by Carver.94 The inventory has been
adapted and validated for Arabic contexts (Cronbach’s
alpha: 0.83).95 This tool has been used to measure coping
strategies of family caregivers of stroke survivors.17 96
Brief-­COPE is a self-­rated questionnaire and consists of
28 items in 14 domains. Each domain consists of two
items. Responses range from 1 (I haven't been doing thisat all) to 4 (I've been doing this a lot). Total scores ofeach domain range from 2 (minimum) to 8 (maximum).
High scores in a particular domain show that this specificcoping strategy has been used more frequently. The total
inventory score can be obtained by adding the relating
items for each scale.
Quality of life
QoL is measured using the WHO Quality of Life-­BREF(WHOQOL-­
BREF), developed with a cross-­culturalperspective by the WHO for various languages, and used
to assess the QoL of the family caregivers of stroke survivors in previous studies.22 67 77 97–100 The WHOQOL-­BREF
is a self-­rated questionnaire consisting of 26 questions—2
general questions and 24 questions covering fourdomains: physical, psychological, social relationships andenvironment. Items are rated on a 5-­point Likert scale(from 1 to 5). All four domains of the instrument havebeen adapted and validated for Arabic settings (Cronbach’s alpha: ≥0.75).101 There is no cut-­off point for the
worst or better QoL scores. Higher scores indicate better
QoL.102
Sample size
The sample size was estimated using G power software
V.3.1.9.4 (Psychonomic Society, Madison, Wisconsin,USA)103 with an effect size of 0.72, which was based on asimilar previous study on care burden among the family
caregivers using ZBI.104 Assuming power analysis results
for the difference between two independent means (twogroups) and a confidence level of 0.95, statistical powerof 0.90 and fair division, the sample size was required to
be 84 caregivers. An additional 26 caregivers need to be
recruited to compensate for an estimated dropout rate of
30%.105 106 The final sample size is 110 participants (55 in
the IG and 55 in the CG).

include data regarding the kinship between the stroke
survivor and their family caregiver, whether or not the
caregiver has children, whether or not the caregiver is
employed, duration of caregiving (in months), numberof caring hours per week and availability of secondary
caregivers. Baseline data will also include stroke-­related
information, such as time since the stroke (in months),
whether first stroke or recurrent, mRS score, dementia
level, difficulties associated with stroke such as aphasia,
dysphagia, difficulty hearing or blurred vision. Primaryand secondary outcomes will be analysed and comparedwith baseline data. Quantitative variables will be expressed
as means and SDs. For qualitative variables, absolute andtest, therelative frequencies will be presented. The t-­
Mann-­Whitney U test, Pearson’s Χ2 test or Fisher’s exact
test will be used depending on normality to compare thetwo groups.
The independent t-­test will be used to compare themean values of the study outcomes between the two
independent groups (the IG and CG) at both T1 andT2. Analysis of covariance will be used to assess the effectof the intervention on the outcomes, after adjusting forconfounding variables such as age and sex of the family
caregivers, the presence of children, number of caregiving hours, availability of secondary caregivers, dependency level, dementia level of stroke survivors, and otherconfounding variables related to the caregivers and thestroke survivors. Repeated measures analysis of variancewill be conducted to assess changes in outcomes overtime.
All statistics will be two-­sided, and the significancelevel will be set at <0.05. The SPSS V.22.0 will be used foranalysis. Last observation carried forward will be used tocompensate for missing data. As bias in estimating theeffects of the intervention is anticipated due to the open-­label design of the study, the analysis will be performedby an independent researcher who will not involve in theintervention or allocation of participants.

Statistical analyses
This will be an intention-­to-­treat analysis.107 108 To ensurecomparability between the IG and the CG, all baseline
data will be analysed using descriptive statistics. Baseline
data will include general characteristics of the participating stroke survivors and their family caregivers suchas age, sex, marital status, education level, place of residence (rural or urban), income (sufficient or insufficient) and the presence of chronic diseases. It will also

Procedures to improve the adherence level
Our proposed intervention includes various ways toimprove adherence. First, we only include participants
who care for stroke survivors with mRS 3–5. We assume
the family caregivers who provided care for stroke survivors that need a higher level of assistance resulting ina lower dropout rate among the participants. Second,
the intervention is tailored to the perceived needs of the
caregivers, thereby increasing the adherence level andraising the intervention effectiveness. Third, to improveadherence, we use various methods of delivery in shorttime intervals (biweekly). Last and foremost, we assign
six or seven participants in the IG to each intervention nurse. The nurse is responsible for administering
the intervention and following the participants during
the study period. Participants also have the opportunity to contact the nurse to ask questions or to provide
feedback.

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Open accessETHICS AND DISSEMINATION
All procedures contributing to this study shall comply
with the ethical standards of the 1975 Helsinki Declaration (2008 revised version). The study protocol has beenreviewed and approved by the Research Ethics Committeeof the Faculty of Nursing, Mansoura University, Mansoura,
Egypt, in September 2019 (P.0195). Important protocol
modifications (eg, changes to eligibility criteria, outcomes,
analyses) shall be communicated to the Research Ethics
Committee. All participants are provided oral and written
information on the study and asked to sign an informed
consent form before being enrolled. The study participants are informed that all data collected are for research
purposes only, and that they have the right to withdraw
from the study at any time.
Data collection is fully anonymised and only accessedby authorised study staff. The permissions to use all the
study tools have been granted by the original authors.

DISSEMINATION OF THE RESEARCH FINDINGS
Study findings will be published in a scientific peer-­
reviewed journal according to CONSORT guidelines
for RCTs.58 Participants will be informed of conference
presentations and publications.
Author affiliations
1
Graduate School of Biomedical and Health Sciences, Hiroshima University,
Hiroshima, Japan
2
Community Health Nursing Department, Faculty of Nursing, Cairo University, Cairo,
Egypt
3
Psychiatric and Mental Health Nursing Department, Faculty of Nursing, Mansoura
University, Mansoura, Egypt
4
New Mansoura General Hospital, Neurology, Ministry of Health and Population,
Mansoura, Egypt
5
Neurology, Mansoura University Faculty of Medicine, Mansoura, Egypt
6
Psychiatry, Mansoura University Faculty of Medicine, Mansoura, Egypt
Acknowledgements The authors thank the Cultural Affairs and Missions Sector,
Ministry of Higher Education, Cairo, Egypt, for financial support for the principal
investigator’s travel to Japan, which has a better developed system (than does
Egypt) in designing and implementing family caregiver supportive interventions.
The authors also thank Hatano Rehabilitation Group, Aki-­Ku, Hiroshima, Japan,
for support and training in home visit nursing, telephone nursing interventions,whole family assessments and care management processes, and for the use of
space, equipment and the preparation of educational materials for the training ofintervention nurses. Lastly, the authors would like to thank Editage for providing
editorial assistance.
Contributors MAE is the principal investigator responsible for the initial draftof this manuscript, and organising and implementing the study. MAE, MM, MMR
and MK formulated the study design, developed the intervention and defined thestudy outcomes. MA, MHK and HZ helped in recruitment and retention of the study
participants. MAE, AHE-­M, MZ and MK calculated the sample size and decided on
the data analysis plan. MAE, MA, MHK, AHE-­M, MZ and HZ designed the tailoredmultidimensional plans and ensured the implementation and follow-­up. MM, MMR
and MK did periodic review of the implementation process and gave valuable
feedback. MAE, MA, MHK, AHE-­M and MZ trained the intervention nurses. All
authors have read and approved the final manuscript.
Funding The authors have not declared a specific grant for this research from any
funding agency in the public, commercial or not-­for-­profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in
the design, or conduct, or reporting, or dissemination plans of this research.

8

Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Open access This is an open access article distributed in accordance with theCreative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-­commercially,and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/.
ORCID iDs
Mahmoud Ahmed Elsheikh http://​orcid.​org/​0000-​0002-​4256-​9516
Md Moshiur Rahman http://​orcid.​org/​0000-​0002-​5475-​986X
Ahmed Hashem El-­Monshed http://​orcid.​org/​0000-​0002-​0085-​4685
Mohamed Zoromba http://​orcid.​org/​0000-​0002-​4298-​1121

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