Family-centered Support Program for Caregivers of Stroke Survivors

Not Applicable

Completed

• Conditions: Stroke; Caregiver Burden
• Interventions: Other: Family-centered support program for caregivers of stroke survivors

• Registration Number: NCT05668169
• Lead Sponsor: wen yu Kuo, assistant professor

Brief Summary

The goal of this study is to evaluate the effect of a family-centered support program on the care burden, depressive symptoms, perceived social support, and quality of life of stroke survivor' caregivers and on care recipients' rehabilitation adherence and depressive symptoms.

Detailed Description

The family-centered support program included stroke and rehabilitation education, problem-solving skills training, long-term care information support, and instant messaging applications-based 24-h peers-support group for caregivers.

Investigators hypothesized that (1) Compared with those in the control group, caregivers who undergo a family-centered support program have lower care burdens, do not have a high risk of depression, and perceive better social support and quality of life; (2) Compared with those in the control group, care recipients in the family-centered support group have ideal rehabilitation adherence and are not at a high risk of depression.

Study Timeline

• Study Start: 2021-08-16
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2022-12-29
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Caregivers:

   • Aged 20 years or older
   • Primarily responsible for caring for the stroke survivor in the hospital and after discharge.

2. Stroke survivors:

   • Diagnosed with moderate stroke (National Institute of Health Stroke Scale ≥5 or Modified Rank in Scale ≥3), including ischemic and hemorrhagic stroke, via computed tomography or magnetic resonance imaging within one month. admitted to the stroke unit at a medical center
   • Had a primary family caregiver.

Exclusion Criteria

1. Caregivers:

   • Refusal to participate in the study
   • Unable to communicate, for example, non-Chinese speakers
   • Reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.

2. Stroke survivors:

   • Unstable vital signs
   • Terminal illness
   • Transfer to long-term care facilities after hospital discharge
   • Self-reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family-centered support program for caregivers of stroke survivors	Family-centered support program for caregivers of stroke survivors	Participants receive usual hospital care and our intervention

Primary Outcome Measures

Name	Time	Method
Change from baseline depressive symptoms at first month	The outcome was assessed at first month after inclusion.	Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
Change from baseline caregivers' quality of life at first month	The outcome was assessed at first month after inclusion.	Taiwanese version of the World Health Organization Quality of Life BREF(WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life.WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
Depressive symptoms	The outcome was assessed at baseline.	Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
Caregiver care burden	The outcome was assessed at baseline.	The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
Perceived social support	The outcome was assessed at baseline.	Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
Rehabilitation adherence	The outcome was assessed at baseline.	A single item of rehabilitation adherence measurement was used to measure stroke Patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
Change from baseline perceived social support at first month	The outcome was assessed at first month after inclusion.	Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
Change from baseline depressive symptoms at third month	The outcome was assessed at third after inclusion.	Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
Change from baseline perceived social support at third month	The outcome was assessed at third after inclusion.	Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
Caregivers' quality of life	The outcome was assessed at baseline.	Taiwanese version of the World Health Organization Quality of Life BREF(WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life. WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
Change from baseline caregiver care burden at first month	The outcome was assessed at first month after inclusion.	The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
Change from baseline caregiver care burden at third month	The outcome was assessed at third after inclusion.	The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
Change from baseline caregivers' quality of life at third month	The outcome was assessed at third after inclusion.	Taiwanese version of the World Health Organization Quality of Life BREF (WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life. WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
Change from baseline rehabilitation adherence at first month	The outcome was assessed at first month after inclusion.	A single item of rehabilitation adherence measurement was used to measure stroke patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
Change from baseline rehabilitation adherence at third month	The outcome was assessed at third after inclusion.	A single item of rehabilitation adherence measurement was used to measure stroke patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.

Trial Locations

Locations (1)

Chang Gung University of Science and Technology; 🇨🇳 Taoyuan, Taiwan