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Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: study protocol for a randomised controlled trial
  1. Mahmoud Ahmed Elsheikh1,2,
  2. Michiko Moriyama1,
  3. Md Moshiur Rahman1,
  4. Mayumi Kako1,
  5. Ahmed Hashem El-Monshed3,
  6. Mohamed Zoromba3,
  7. Hamada Zehry4,
  8. Maha Hazem Khalil5,
  9. Mostafa Amr6
  1. 1Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
  2. 2Community Health Nursing Department, Faculty of Nursing, Cairo University, Cairo, Egypt
  3. 3Psychiatric and Mental Health Nursing Department, Faculty of Nursing, Mansoura University, Mansoura, Egypt
  4. 4New Mansoura General Hospital, Neurology, Ministry of Health and Population, Mansoura, Egypt
  5. 5Neurology, Mansoura University Faculty of Medicine, Mansoura, Egypt
  6. 6Psychiatry, Mansoura University Faculty of Medicine, Mansoura, Egypt
  1. Correspondence to Mahmoud Ahmed Elsheikh; d194332{at}


Introduction Caring for stroke survivors creates high levels of care burden among family caregivers. Previous initiatives at alleviating the care burden have been unsuccessful. The proposed study aims to evaluate the effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors. Based on the perceived needs of family caregivers, this intervention 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 administered for 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 the mean 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 effect over 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, and findings will be disseminated at the local and international levels.

Trial registration number NCT04211662.

  • stroke medicine
  • public health
  • quality in health care

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  • Contributors MAE is the principal investigator responsible for the initial draft of this manuscript, and organising and implementing the study. MAE, MM, MMR and MK formulated the study design, developed the intervention and defined the study 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 tailored multidimensional 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.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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