Family-centered Support Program for Caregivers of Stroke Survivors

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Caregiver Burden
• Intervention / Treatment: Other: Family-centered support program for caregivers of stroke survivors

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33303
    • Chang Gung University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family-centered support program for caregivers of stroke survivors; Participants receive usual hospital care and our intervention	Other: Family-centered support program for caregivers of stroke survivors; Once participants joined the family-centered support group, participants received 90-minute interventions, including an introduction to stroke and rehabilitation education, problem-solving skills training, and long-term care information. Investigators also invited participants to join the instant messaging application-based 24-h peer-support group for caregivers. On the second and fourth days after receiving the interventions, the researcher visited the participants to review and practice the content provided on the first day; each session was 30 to 40 minutes long. The researcher contacted the participants one week after participants joined the study to discuss their care difficulties or experiences and did so three times biweekly thereafter via the instant messaging application.
No Intervention: No Intervention: Control group; Participants receive only usual hospital care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	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.	The outcome was assessed at baseline.
Caregiver care burden	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.	The outcome was assessed at baseline.
Perceived social support	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.	The outcome was assessed at baseline.
Caregivers' quality of life	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.	The outcome was assessed at baseline.
Rehabilitation adherence	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.	The outcome was assessed at baseline.
Change from baseline depressive symptoms at first month	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.	The outcome was assessed at first month after inclusion.
Change from baseline caregiver care burden at first month	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.	The outcome was assessed at first month after inclusion.
Change from baseline perceived social support at first month	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.	The outcome was assessed at first month after inclusion.
Change from baseline caregivers' quality of life at first month	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.	The outcome was assessed at first month after inclusion.
Change from baseline rehabilitation adherence at first month	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.	The outcome was assessed at first month after inclusion.
Change from baseline depressive symptoms at third month	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.	The outcome was assessed at third after inclusion.
Change from baseline caregiver care burden at third month	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.	The outcome was assessed at third after inclusion.
Change from baseline perceived social support at third month	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.	The outcome was assessed at third after inclusion.
Change from baseline caregivers' quality of life at third month	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.	The outcome was assessed at third after inclusion.
Change from baseline rehabilitation adherence at third month	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.	The outcome was assessed at third after inclusion.

Collaborators and Investigators

• Sponsor: wen yu Kuo, assistant professor
• Collaborators: Chang Gung Memorial Hospital; National Science and Technology Council

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Estimate): December 29, 2022

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: family-centered intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Stroke; Caregiver Burden
• Other Study ID Numbers: MOST 110-2314-B-255-001 -

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No