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Completed

NCT Number: NCT05668169

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Caregiver Burden Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stress, Psychological Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University of Science and Technology

Taoyuan, 33303, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • 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.

Treatment and study plan

Family-centered support program for caregivers of stroke survivors

Other

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.

Primary outcomes

  1. Depressive symptoms

    Time frame: 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.

  2. Caregiver care burden

    Time frame: 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.

  3. Perceived social support

    Time frame: 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.

  4. Caregivers' quality of life

    Time frame: 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.

  5. Rehabilitation adherence

    Time frame: 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.

  6. Change from baseline depressive symptoms at first month

    Time frame: 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.

  7. Change from baseline caregiver care burden at first month

    Time frame: 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.

  8. Change from baseline perceived social support at first month

    Time frame: 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.

  9. Change from baseline caregivers' quality of life at first month

    Time frame: 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.

  10. Change from baseline rehabilitation adherence at first month

    Time frame: 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.

  11. Change from baseline depressive symptoms at third month

    Time frame: 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.

  12. Change from baseline caregiver care burden at third month

    Time frame: 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.

  13. Change from baseline perceived social support at third month

    Time frame: 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.

  14. Change from baseline caregivers' quality of life at third month

    Time frame: 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.

  15. Change from baseline rehabilitation adherence at third month

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

wen yu Kuo, assistant professor

Other

Collaborators

  • Chang Gung Memorial Hospital
  • National Science and Technology Council

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2022
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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