StrokeNCT05668169
Family-centered Support Program for Caregivers of Stroke Survivors
A study testing Family-centered support program for caregivers of stroke survivors in people with Stroke and Caregiver Burden, run by wen yu Kuo, assistant professor at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Caregiver Burden
- What is being tested?
- Family-centered support program for caregivers of stroke survivors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Aug 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Caregiver Burden
- Being tested
- Family-centered support program for caregivers of stroke survivors
- Keywords
- family-centered intervention
- Medical subject headings
- Stroke, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-centered support program for caregivers of stroke survivorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Family-centered support program for caregivers of stroke survivors | Experimental | Participants receive usual hospital care and our intervention Receives: Other: Family-centered support program for caregivers of stroke survivors |
| No Intervention: Control group | No intervention | Participants receive only usual hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The outcome was assessed at third after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start16 Aug 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The family-centered support program included four components: (A) Stroke and rehabilitation education. (B) Problem-solving skills training. (C) Long-term care information support. (D) Instant messaging application-based 24-h peers-support group for caregivers.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- wen yu Kuo, assistant professor
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Chang Gung Memorial Hospital
- Responsible party
- Sponsor-investigator, wen yu Kuo, assistant professor, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668169
- Sponsor's protocol ID
- MOST 110-2314-B-255-001 -
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-centered Support Program for Caregivers of Stroke Survivors
- ClinicalTrials.gov ID
- NCT05668169
- Acronym / sponsor ID
- MOST 110-2314-B-255-001 -
- Conditions
- Stroke, Caregiver Burden
- Keywords
- family-centered intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- wen yu Kuo, assistant professorUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Chang Gung Memorial Hospital
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The family-centered support program included four components: (A) Stroke and rehabilitation education. (B) Problem-solving skills training. (C) Long-term care information support. (D) Instant messaging application-based 24-h peers-support group for caregivers.
| Arm | Type | Receives |
|---|---|---|
| Family-centered support program for caregivers of stroke survivors | Experimental | Other: Family-centered support program for caregivers of stroke survivorsParticipants receive usual hospital care and our intervention |
| No Intervention: Control group | No intervention | –Participants receive only usual hospital care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caregivers:
- Stroke survivors:
Key exclusion criteria (9 listed)
- Caregivers:
- Stroke survivors:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-centered support program for caregivers of stroke survivorsOnce 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. | Other | Family-centered support program for caregivers of stroke survivors |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-centered support program for caregivers of stroke survivors in people with Stroke and Caregiver Burden, run by wen yu Kuo, assistant professor at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: The outcome was assessed at baseline.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.