Effect of a Tailored Multidimensional Intervention on the Care Burden Among Family Caregivers of Stroke Survivors

NCT04211662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-08-19

No results posted yet for this study

Summary

Family caregivers are the key persons in the recovery and rehabilitation process of stroke survivors. Despite multiple researches recommended the development of interventions which are based on the family caregivers' needs and recommended the conduction of the interventions based on the integration of skill-building, psychoeducation, and peer support to relieve the care burden they feel, there are no studies conducted to evaluate the effect of such these interventions on the family caregivers of stroke survivors in Egypt. The purpose of this study is to evaluate the effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors. Using a randomized control trial, 110 family caregivers will be recruited from the community; from the outpatient clinics and rehabilitation clinics which are located at Mansoura city (Capital of Dakahlia Governorate) and the surrounding cities and villages. The participants will be randomized through 1:1 open-label randomization to the intervention group and the control group. The intervention group will receive the tailored multidimensional intervention. The intervention will last for 6 months. 3 home visits and 3 telephone interventions and 1 peer support will be conducted during the first 3 months. the home visits and telephone interventions will be conducted biweekly alternately. During the second 3 months, 3 telephone follow-ups will be conducted monthly. Regarding the control group, they will receive a simple educational booklet through one home visit. The primary outcome is the care burden (Zarit Burden Interview) and secondary outcomes are the perceived needs (Family Needs Questionnaire-Revised), coping strategies (Brief Coping Orientation to Problems Experienced) and quality of life (World Health Organization Quality of Life-BREF) among family caregivers. The primary and secondary outcomes will be assessed basically before the intervention and after the 3rd and 6th months since the start of the intervention.

Conditions

  • Stroke
  • Caregiver Burden
  • Caregiver Burnout

Interventions

BEHAVIORAL

Tailored Multidimensional Intervention. the tailored intervention will be implemented through 6 months using a multidimensional approach (skill building, psychoeducation and peer support).

Skill-building can be defined as training the family caregivers the following skills (1) hands-on training in such skills as positioning, transferring and mobility techniques and assistance with activities of daily living; (2) coping strategies and stress management (3) communicating with healthcare professionals. Psycho-education is teaching and provision the family caregivers the knowledge and information regarding stroke (stroke definition, types of stroke, risk factors, prevention of recurrent stroke, medication management, stroke complications and measures for prevention and management of these complications). Besides, family caregivers will be taught and given the knowledge and information regarding managing stroke survivors' emotions and behaviors. Peer support can be defined as engaging the family caregivers of stroke survivors in interactions with their peers for support and exchanging advices and experiences.

Sponsors & Collaborators

  • Hiroshima University

    collaborator OTHER
  • Mansoura University

    collaborator OTHER
  • Cairo University

    lead OTHER

Principal Investigators

  • Mahmoud A Elsheikh, PhD Student · Hiroshima University

  • Michiko Moriyama, Professor · Hiroshima University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-27
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211662 on ClinicalTrials.gov