Effect of a Tailored Multidimensional Intervention on the Care Burden Among Family Caregivers of Stroke Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Measuring the change of the Care burden among family caregivers of stroke survivors (Zarit Burden Interview)
Study Overview
Brief 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.
Detailed Description
Introduction:
Cardiovascular diseases (CVD) including stroke is the first leading cause of death worldwide. It was estimated 17.9 million people died from CVDs in 2016, representing 31 percentage of all global deaths. Of these deaths, 85 percentage are due to heart attack and stroke. Over 75 percentage of CVD deaths take place in low- and middle-income countries. Besides, stroke is one of the leading causes of severe long-term disability. Stroke is the second cause of Disability-Adjusted Life Years (DALYs) globally after ischemic heart disease. Stroke is the second of DALYs in the developing countries and the third cause to DALYs in the developed countries.
A stroke affecting one of the family members is a stressful event or shock for all family members; especially the primary family caregiver. The concept of stroke is usually attached to chronic functional, cognitive and behavioral changes. These changes require daily assistance for the stroke patients in performing Activities of Daily Livings (ADLs) and Instrumental Activities of Daily Livings (IADLs). A family caregiver is committed to assist the stroke patient to perform these activities.
Caregiving for a stroke survivor creates imbalance and strain between the personal life of the family caregiver and the provision of the caregiving role. Caregiving for stroke survivors conveys physical, psychological, social and financial burdens upon the family caregiver. In addition, the feeling of burden among family caregivers of stroke survivors interferes with the rehabilitation and quality of life of the stroke survivors and increases the risk of mortality.
Since stroke is a sudden condition that forces the family to provide care for their loved person without preparedness, it brings out multiple challenges to which the family caregivers must adapt without compromising their own life. So, the interventions are directed to prepare the family caregivers adequately to be able to perform their caring role and at the same time to reduce the burden of care and to maintain their quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants will be included if they meet the following criteria:
- •who is 18 years old or more and
- •who is caring for stroke survivors having stroke within 6 months ago and with modified Rankin scale scores equal 3 to 5.
Exclusion Criteria
- •Family caregivers will be excluded:
- •if they have cognitive impairments.
- •if their stroke survivors have one of the following conditions: (1) the stroke survivors have other limitations of mobility such as (fracture, dislocation, spinal cord injury, spinal vertebrae injury); and (2) the stroke survivor has terminal stage diseases such as end-stage cancer, end-stage liver disease and end-stage kidney disease or any other end-stage diseases.
Outcomes
Primary Outcomes
Measuring the change of the Care burden among family caregivers of stroke survivors (Zarit Burden Interview)
Time Frame: baseline, 3 months, 6 months
Care burden can be defined in this context as the personal strain and role strain that the family caregiver experienced due to caring for one of the family. members having stroke. Consequently, the family caregivers will suffer from physical or psychological or emotional or social or financial complains. The Short version (12 items) of Zarit Burden Interview will be used. Items are rated on a 5-point Likert scale from 0 (never) to 4 (almost always). the validated Arabic version will be used.
Secondary Outcomes
- Measuring the change of the Quality of Life among family caregivers of stroke survivors (WHOQOL-BREF)(baseline, 3 months and 6 months)
- Measuring the change of the perceived needs of family caregivers of stroke survivors (Family Needs Questionnaire- Revised (FNQ-R)(baseline, 3 months and 6 months)
- Measuring the change of the coping strategies among family caregivers of stroke survivors (Brief-COPE (Coping Orientation to Problems Experienced) Inventory)(baseline, 3 months and 6 months)
Investigators
Mahmoud Ahmed Ahmed Ahmed Elsheikh
Assistant Lecturer, Cairo University & PhD student, Hiroshima University
Cairo University