Family-centered Support Program for Caregivers of Stroke Survivors

Stroke Clinical Trial

Official title:

Family-centered Support Program for Caregivers of Stroke Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668169
• Other study ID #: MOST 110-2314-B-255-001 -
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Stroke

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung University of Science and Technology	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
wen yu Kuo, assistant professor	Chang Gung Memorial Hospital, National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.