StrokeNCT03034330
A Two-Tier Care Management Program to Empower Stroke Caregivers in Hong Kong
A study testing Two-Tier Stroke Family Empowerment and Volunteer Support Psychoeducation in people with Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study intends to develop a family-based care management intervention with primary aims to provide time-limited support for family caregivers affected by stroke and to empower caregivers through enhancing the family adaptation and functioning and increasing their capacity of stroke care. The objectives include: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Two-Tier Stroke Family Empowerment and Volunteer Support Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2017to Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A stroke caregiver is eligible to participate in the study if:
- He / She is a Chinese adult aged 18 or above;
- He / She has a family member has the first stroke (ischaemic or haemorrhagic stroke) at the age of 50 or above and has been discharged from the acute hospital for no more than 6 months;
- He / She provides care or being with the stroke survivor for no less than two hours per day after discharge from the acute hospital;
- He / She reports significant caregiver burden as measured by the 12-item Zarit Burden Interview (a total score ≥ 12).
- A stroke survivor is eligible to participate in the study if:
Show all 12Show fewer
- He / She is a Chinese adult aged 50 or above;
- He / She has been discharged from the acute hospital for no more than 6 months;
- His / Her family caregiver participates in this study;
- He/ She is able to communicate with interventionists and interviewers;
- He/ She is competent to give written informed consent.
- Stroke survivors whose caregivers in the intervention group will receive both the intervention and the questionnaire interviews. Stroke survivors whose caregiver in the control group will only need to take part in the questionnaire interview.
Who cannot join
- A stroke caregiver will be excluded from participation if:
- His / Her family member has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke;
- His / Her family member with stroke is residing in a residential care facility after discharge from the acute hospital;
- He / She is diagnosed as having Alzheimer's disease or other dementias;
- He / She is unable to understand Cantonese.
- A stroke survivor is not eligible to participate in the study if:
Show all 11Show fewer
- He / She is residing in a residential care facility after discharge from the acute hospital;
- He/ She has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke;
- His / Her family caregiver refuses to participate in this study;
- He/ She is not able to communicate with interventionists and interviewers;
- He/ She is not competent to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Tier Care Management Program to Empower Stroke Caregivers in Hong Kong: A Randomized Controlled Trial
This study intends to develop a family-based care management intervention with primary aims to provide time-limited support for family caregivers affected by stroke and to empower caregivers through enhancing the family adaptation and functioning and increasing their capacity of stroke care. The objectives include:
- To examine the effectiveness of the proposed family-based intervention to improve family, caregiver, and service outcome.
- To examine the cost-effectiveness of the proposed family intervention.
It is hypothesized that comparing to the control group, the experimental group participants will have more and significant outcome.
Read the detailed description
This study will recruit 300 caregivers of first stroke survivors to involve in the intervention and employ a randomized controlled trial (RCT) to assign the caregivers into the intervention group and active control group. Each group will have 150 caregivers. The intervention is individualized, tailor-made according to caregivers' needs. Care managers will conduct an initial family need assessment with caregivers to determine their care plan. The intervention will last for 2 to 3 months with 6 to 10 weekly sessions. If the caregiver participants' family member with stroke (stroke survivors) agrees to and is competent enough( see Eligibility Criteria Criteria), they will also be invited to take part in up to 4 intervention sessions.
The active control group will receive a standard, non-family-based psychoeducation intervention provided by the trained volunteers under the supervision of care managers. The active control group will not involve stroke survivors. Therefore, a maximum of 150 stroke survivors will be involved in the intervention.
Both caregivers participants (300) and their family members with stroke (300) will be asked to do questionnaires before (T1), immediately after (T2) and 2 months after (T3) the intervention. The intervention and the questionnaire interview will take place at the homes of participants.
The participation of the stroke survivors in the intervention and the questionnaire interview will not affect the involvement of their caregivers in this study. In other words, caregivers can still take part in the intervention and the questionnaire interview if their family members with stroke refuse to or are not competent ( see Eligibility Criteria Criteria) to take part in this study.
No drug usage and medical treatment will be involved in the study. Intervention and questionnaires do not impose any physical or medical risk to participants. The only possible problem may be caregivers may feel a little tired after the intervention. Participants can voluntarily drop out the study at any time, without giving any reason, without my medical care or original rights being affected.
Both the effectiveness and the cost-effectiveness will be evaluated in this study (See Outcome Measures). Chi-square or independent t-tests will be used to examine the differences in the baseline characteristics between the intervention and control groups. To assess the effectiveness of the intervention, regression analysis will be used to compare the difference in outcomes between the intervention and control groups, controlling for the effect of potential covariates. Recruitment rate, drop-out rate and missing data will also be examined and reported.
The principal investigator will be responsible for keeping of the personal data during and after the study. The data will be for academic and clinical research only and will be kept for up to 5 years and will be destroyed after that.
- Conditions
- Stroke
- Being tested
- Two-Tier Stroke Family Empowerment, Volunteer Support Psychoeducation
- Keywords
- informal care, empowerment, family-focused intervention, stroke rehabilitation
- Medical subject headings
- Stroke, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Tier Stroke Family EmpowermentOther
The family-based care management intervention will be implemented in two tiers. The first tier is the Family Care Management that a care manager is responsible for empowering family caregivers to support their stroke survivors through reorganizing family roles, enhancing family functioning, and maximizing their family and community resources. The second tier is led by trained volunteers who are responsible for increasing the capacity of caregivers for the mastery of stroke care by providing psychoeducation, skill-training, and social support. Each caregiver participant will be assigned a care manager and a volunteer. All care managers who are social workers from the participating centres have undergone 4-day training to improve their knowledge of stroke and skills required for the intervention. Similarly, volunteers have undergone 6.5-day training to equip them with the knowledge and skills to conduct the intervention.
Volunteer Support PsychoeducationOther
The active control group will receive a standard, non-family-based psychoeducation intervention provided by the trained volunteers under the supervision of care managers. It will provide 4 in-home visits and 2 telephone follow-up interviews about psychoeducation for caregivers of stroke survivors.
| Study group | Role | What they receive |
|---|---|---|
| Two-Tier Stroke Family Empowerment | Experimental | The intervention is individualized, tailor-made according to caregivers' needs. The intervention will last for 2 to 3 months with 6 to 10 weekly sessions at the home of caregivers or stroke survivors. Each session will last for 60 to 90 minutes. The care managers will determine the intensity of the intervention after the initial family assessment. Receives: Other: Two-Tier Stroke Family Empowerment |
| Volunteer Support Psychoeducation | Active comparator | The intervention will last for 2 months with 4 weekly sessions at the home of caregivers or stroke survivors in the first month and 2 telephone contacts in the second month (6 contact points in total). Each session will last for 60 to 90 minutes. Care managers will not provide any direct intervention for participants in the control group. Receives: Other: Volunteer Support Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Role Performance measured by the Family Role Performance Scale (Questionnaire)
Family Role Performance Scale: The research team develops this scale to measure the frequency and ability of the family member to perform six major family roles, which are advisor, emotional connector, breadwinner, caretaker, decision maker and caregiver. The scale has two parts. The first part contains 6 items and asks participants how often they perform the six family roles. The second part contains 6 items and asks participants to rate their performance regarding to the family roles.
Measured: 6 months
Care Management Strategies measured by the Care Management Strategies Scale (Questionnaire)
Care Management Strategies Scale: This is a 5-point Likert scale developed by the research team to find out the care management behaviors proposed by stroke caregivers. The scale contains 18 items.
Measured: 6 months
Family Caregiver Conflict measured by Family Caregiver Conflict Scale (FCCS) (Questionnaire)
Family Caregiver Conflict Scale (FCCS): This is a 5-Likert-type scale with 15 items to assess family conflict due to stroke. It has four subscales: communication, problem solving, general family functioning, and perceived criticism (Clark, Shields, Aycock, \& Wolf, 2003).
Measured: 6 months
Family Function measured by the Family Assessment Device-General Functioning Scale (FAD-GF) (Questionnaire)
Family Assessment Device-General Functioning Scale (FAD-GF): This study will use the 12-item general functioning of the McMaster Family Assessment Device (Epstein, Baldwin, \& Bishop, 1983) to measure the family functioning of caregivers. Responses are given using a 4-point Likert scale (1 = strongly agree to 4 = strongly disagree).
Measured: 6 months
Secondary outcomes (19)
Caregiver Burden measuewd by the Cantonese Short Version of Zarit Burden Interview (questionnaire)
Cantonese Short Version of Zarit Burden Interview: It is a spoken Cantonese version of the 12-item Zarit Burden Interview (ZBI) to assess the burden of Chinese dementia caregivers in clinical and social care settings (Tang et al., 2015). Participants answer on a 5-point scale ranging from 0 (never) to 4 (very frequently) regarding how often they feel burdened by their caregiving duties (e.g., "feel stressed between caregiving and meeting other responsibilities").
Measured: 6 months
Depressive symptoms measured by the The Patient Health Questionnaire-9 (PHQ-9) (Questionnaire)
The Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a reliable and valid instrument for assessing depressive symptoms of the general population in Hong Kong. It has 9 questions and was developed to correspond to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for major depression (Yu, Tam, Wong, Lam, \& Stewart, 2012).
Measured: 6 months
Ambivalence between caregivers and care receivers measured by the Caregiving Ambivalence Scale (Questionnaire)
Caregiving Ambivalence Scale: This scale is based on the Intergenerational Ambivalence Scale (Guo, Chi, \& Silverstein, 2013) to measure the level of ambivalence between caregivers and care receivers. The scale for caregivers has six items, three asking the positive components and three asking the negative components of their relationships (0 = not at all, 1 = somewhat, and 2 = very). The scale for care receivers has one more item than the caregiver scale asking the question "Do you have tense and strained feelings when think about your relationship with your domestic help?"
Measured: 6 months
The mental or affective state of caregivers in relation to stressful caregiving experience measured by the Positive Aspects of Caregiving (PAC) (Questionnaire)
Positive Aspects of Caregiving (PAC): PAC scale measures the mental or affective state of caregivers in relation to stressful caregiving experience (Tarlow et al., 2004). The scale contains 11 questions and responses are given using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) (Lou, Lau, \& Cheung, 2015).
Measured: 6 months
Social network of caregivers measured by the Lubben Social Network Scale (LSNS) (Questionnaire)
Lubben Social Network Scale (LSNS): The original Chinese versions of the Lubben Social Network Scale (LSNS) comprises 10 questions that rate the level of social support. Each question ranges from 0 to 5; higher scores indicate a better social network (Lubben, 1988).
Measured: 6 months
Contemporary filial piety of caregivers measured by the Contemporary Filial Piety Scale (CFPS-10) (Questionnaire)
Contemporary Filial Piety Scale (CFPS-10): This is a 5-point Likert scale scale with 10-items to assess contemporary filial piety in the 21st century. It tests two factors. The first factor, Pragmatic Obligations, contained 6 filial behavior items related to practical and pragmatic caregiving. The second factor, Compassionate Reverence, contained 4 filial attitude items related to emotional caregiving (Lum et al., 2015).
Measured: 6 months
Stroke knowledge of caregivers measured by the Stroke Knowledge Test (SKT) (Questionnaire)
Stroke Knowledge Test (SKT): The stroke health literacy of caregivers is measured by a Stroke Knowledge Test (SKT) tailored for this project by a physician with expertise in neurology who is in charge of a stroke clinic in a major public hospital in Hong Kong. The Test has 9 questions.
Measured: 6 months
Self-rated Health measured by a question to rate their health (Questionnaire)
Self-rated Health: One question will be asked for caregivers and stroke survivors to rate their health "General speaking, what do you think about your physical health?"
Measured: 6 months
Health-related quality of life measured by SF-12 Health Survey (SF-12) (Questionnaire)
SF-12 Health Survey (SF-12): This is a valid and widely used scale with 12 items to measure the health-related quality of life (HRQOL) among the general Chinese population in Hong Kong (Lam, Wong, Lam, Lo, \& Huang, 2010).
Measured: 6 months
Degree of disability or dependence in the daily activities of people who have suffered from a stroke measured by the Simplified Modified Rankin Scale (Questionnaire)
Simplified Modified Rankin Scale: Modified Rankin Scale is a commonly used and reliable scale for measuring the degree of disability or dependence in the daily activities of people who have suffered from a stroke. The simplified version preserves the original construct and validity of the Modified Rankin Scale and makes it relatively simple and short with only 5 questions. The simplified version has good reliability (Bruno, et al., 2011).
Measured: 6 months
The rate of inpatient hospital admission of stroke survivors
Measured: 6 months
Number of specialist outpatient received by stroke survivors
Measured: 6 months
Number of accident and emergency service received by stroke survivors
Measured: 6 months
Number of medicines received by stroke survivors
Measured: 6 months
Number of hospital rehabilitation service received by stroke survivors
Measured: 6 months
Number of home care service received by stroke survivors
Social care services include home care service, day care service, community rehabilitation service, residential care service (admission after study intake).
Measured: 6 months
Number of day care service received by stroke survivors
Measured: 6 months
Number of community rehabilitation service received by stroke survivors
Measured: 6 months
Number of residential care service received by stroke survivors(admission after study intake)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vivian W.Q. Lou, The University of Hong Kong
- Investigators
- Lou Vivian, Vivian, Principal investigator, Sau Po Center on Ageing, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034330
- Sponsor's protocol ID
- UW16-1019
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data collected in this study will be published and submitted to academic journals to share with other researchers.
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Lou VW, Tang JYM, Lau GKK, Lum TYS, Fong K, Ko RWT, Cheng CYM, Fu JY, Chow ESL, Chu ACK, Hui E, Ng WWL, Chan FHW, Luk CC, Kwok TK. Effectiveness of a Two-Tier Family-Oriented Intervention in Enhancing the Family Functioning and Care Capacity of the Family Caregivers of Stroke Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 May 28;10(5):e16703. doi: 10.2196/16703.
PubMed 34047707
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Tier Care Management Program to Empower Stroke Caregivers in Hong Kong: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03034330
- Acronym / sponsor ID
- UW16-1019
- Conditions
- Stroke
- Keywords
- informal care, empowerment, family-focused intervention, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
This study intends to develop a family-based care management intervention with primary aims to provide time-limited support for family caregivers affected by stroke and to empower caregivers through enhancing the family adaptation and functioning and increasing their capacity of stroke care. The objectives include:
- To examine the effectiveness of the proposed family-based intervention to improve family, caregiver, and service outcome.
- To examine the cost-effectiveness of the proposed family intervention.
It is hypothesized that comparing to the control group, the experimental group participants will have more and significant outcome.
Detailed description
This study will recruit 300 caregivers of first stroke survivors to involve in the intervention and employ a randomized controlled trial (RCT) to assign the caregivers into the intervention group and active control group. Each group will have 150 caregivers. The intervention is individualized, tailor-made according to caregivers' needs. Care managers will conduct an initial family need assessment with caregivers to determine their care plan. The intervention will last for 2 to 3 months with 6 to 10 weekly sessions. If the caregiver participants' family member with stroke (stroke survivors) agrees to and is competent enough( see Eligibility Criteria Criteria), they will also be invited to take part in up to 4 intervention sessions.
The active control group will receive a standard, non-family-based psychoeducation intervention provided by the trained volunteers under the supervision of care managers. The active control group will not involve stroke survivors. Therefore, a maximum of 150 stroke survivors will be involved in the intervention.
Both caregivers participants (300) and their family members with stroke (300) will be asked to do questionnaires before (T1), immediately after (T2) and 2 months after (T3) the intervention. The intervention and the questionnaire interview will take place at the homes of participants.
The participation of the stroke survivors in the intervention and the questionnaire interview will not affect the involvement of their caregivers in this study. In other words, caregivers can still take part in the intervention and the questionnaire interview if their family members with stroke refuse to or are not competent ( see Eligibility Criteria Criteria) to take part in this study.
No drug usage and medical treatment will be involved in the study. Intervention and questionnaires do not impose any physical or medical risk to participants. The only possible problem may be caregivers may feel a little tired after the intervention. Participants can voluntarily drop out the study at any time, without giving any reason, without my medical care or original rights being affected.
Both the effectiveness and the cost-effectiveness will be evaluated in this study (See Outcome Measures). Chi-square or independent t-tests will be used to examine the differences in the baseline characteristics between the intervention and control groups. To assess the effectiveness of the intervention, regression analysis will be used to compare the difference in outcomes between the intervention and control groups, controlling for the effect of potential covariates. Recruitment rate, drop-out rate and missing data will also be examined and reported.
The principal investigator will be responsible for keeping of the personal data during and after the study. The data will be for academic and clinical research only and will be kept for up to 5 years and will be destroyed after that.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-Tier Stroke Family Empowerment | Experimental | Other: Two-Tier Stroke Family EmpowermentThe intervention is individualized, tailor-made according to caregivers' needs. The intervention will last for 2 to 3 months with 6 to 10 weekly sessions at the home of caregivers or stroke survivors. Each session will last for 60 to 90 minutes. The care managers will determine the intensity of the intervention after the initial family assessment. |
| Volunteer Support Psychoeducation | Active comparator | Other: Volunteer Support PsychoeducationThe intervention will last for 2 months with 4 weekly sessions at the home of caregivers or stroke survivors in the first month and 2 telephone contacts in the second month (6 contact points in total). Each session will last for 60 to 90 minutes. Care managers will not provide any direct intervention for participants in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A stroke caregiver is eligible to participate in the study if:
- He / She is a Chinese adult aged 50 or above;
- He / She has been discharged from the acute hospital for no more than 6 months;
- His / Her family caregiver participates in this study;
- He/ She is able to communicate with interventionists and interviewers;
Key exclusion criteria (11 listed)
- A stroke caregiver will be excluded from participation if:
- He / She is residing in a residential care facility after discharge from the acute hospital;
- He/ She has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke;
- His / Her family caregiver refuses to participate in this study;
- He/ She is not able to communicate with interventionists and interviewers;
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 |
|---|---|---|
| Two-Tier Stroke Family EmpowermentThe family-based care management intervention will be implemented in two tiers. The first tier is the Family Care Management that a care manager is responsible for empowering family caregivers to support their stroke survivors through reorganizing family roles, enhancing family functioning, and maximizing their family and community resources. The second tier is led by trained volunteers who are responsible for increasing the capacity of caregivers for the mastery of stroke care by providing psychoeducation, skill-training, and social support. Each caregiver participant will be assigned a care manager and a volunteer. All care managers who are social workers from the participating centres have undergone 4-day training to improve their knowledge of stroke and skills required for the intervention. Similarly, volunteers have undergone 6.5-day training to equip them with the knowledge and skills to conduct the intervention. | Other | Two-Tier Stroke Family Empowerment |
| Volunteer Support PsychoeducationThe active control group will receive a standard, non-family-based psychoeducation intervention provided by the trained volunteers under the supervision of care managers. It will provide 4 in-home visits and 2 telephone follow-up interviews about psychoeducation for caregivers of stroke survivors. | Other | Volunteer Support Psychoeducation |
Primary outcome
Family Role Performance measured by the Family Role Performance Scale (Questionnaire)
Time frame: 6 months
Family Role Performance Scale: The research team develops this scale to measure the frequency and ability of the family member to perform six major family roles, which are advisor, emotional connector, breadwinner, caretaker, decision maker and caregiver. The scale has two parts. The first part contains 6 items and asks participants how often they perform the six family roles. The second part contains 6 items and asks participants to rate their performance regarding to the family roles.
Care Management Strategies measured by the Care Management Strategies Scale (Questionnaire)
Time frame: 6 months
Care Management Strategies Scale: This is a 5-point Likert scale developed by the research team to find out the care management behaviors proposed by stroke caregivers. The scale contains 18 items.
Family Caregiver Conflict measured by Family Caregiver Conflict Scale (FCCS) (Questionnaire)
Time frame: 6 months
Family Caregiver Conflict Scale (FCCS): This is a 5-Likert-type scale with 15 items to assess family conflict due to stroke. It has four subscales: communication, problem solving, general family functioning, and perceived criticism (Clark, Shields, Aycock, \& Wolf, 2003).
Family Function measured by the Family Assessment Device-General Functioning Scale (FAD-GF) (Questionnaire)
Time frame: 6 months
Family Assessment Device-General Functioning Scale (FAD-GF): This study will use the 12-item general functioning of the McMaster Family Assessment Device (Epstein, Baldwin, \& Bishop, 1983) to measure the family functioning of caregivers. Responses are given using a 4-point Likert scale (1 = strongly agree to 4 = strongly disagree).
19 secondary outcomes
Caregiver Burden measuewd by the Cantonese Short Version of Zarit Burden Interview (questionnaire)
Time frame: 6 months
Depressive symptoms measured by the The Patient Health Questionnaire-9 (PHQ-9) (Questionnaire)
Time frame: 6 months
Ambivalence between caregivers and care receivers measured by the Caregiving Ambivalence Scale (Questionnaire)
Time frame: 6 months
The mental or affective state of caregivers in relation to stressful caregiving experience measured by the Positive Aspects of Caregiving (PAC) (Questionnaire)
Time frame: 6 months
Social network of caregivers measured by the Lubben Social Network Scale (LSNS) (Questionnaire)
Time frame: 6 months
Contemporary filial piety of caregivers measured by the Contemporary Filial Piety Scale (CFPS-10) (Questionnaire)
Time frame: 6 months
Stroke knowledge of caregivers measured by the Stroke Knowledge Test (SKT) (Questionnaire)
Time frame: 6 months
Self-rated Health measured by a question to rate their health (Questionnaire)
Time frame: 6 months
Health-related quality of life measured by SF-12 Health Survey (SF-12) (Questionnaire)
Time frame: 6 months
Degree of disability or dependence in the daily activities of people who have suffered from a stroke measured by the Simplified Modified Rankin Scale (Questionnaire)
Time frame: 6 months
The rate of inpatient hospital admission of stroke survivors
Time frame: 6 months
Number of specialist outpatient received by stroke survivors
Time frame: 6 months
Number of accident and emergency service received by stroke survivors
Time frame: 6 months
Number of medicines received by stroke survivors
Time frame: 6 months
Number of hospital rehabilitation service received by stroke survivors
Time frame: 6 months
Number of home care service received by stroke survivors
Time frame: 6 months
Number of day care service received by stroke survivors
Time frame: 6 months
Number of community rehabilitation service received by stroke survivors
Time frame: 6 months
Number of residential care service received by stroke survivors(admission after study intake)
Time frame: 6 months
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 16 Mar 2022.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 34047707Lou VW, Tang JYM, Lau GKK, Lum TYS, Fong K, Ko RWT, Cheng CYM, Fu JY, Chow ESL, Chu ACK, Hui E, Ng WWL, Chan FHW, Luk CC, Kwok TK. Effectiveness of a Two-Tier Family-Oriented Intervention in Enhancing the Family Functioning and Care Capacity of the Family Caregivers of Stroke Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 May 28;10(5):e16703. doi: 10.2196/16703.
- Individual participant dataSharing planned: Yes. Data collected in this study will be published and submitted to academic journals to share with other researchers.
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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.
Lou Vivian, Vivian principal investigator
Sau Po Center on Ageing, HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-Tier Stroke Family Empowerment and Volunteer Support Psychoeducation in people with Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
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 12 inclusion and 11 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 16 Mar 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 Hong Kong. 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?
Family Role Performance measured by the Family Role Performance Scale (Questionnaire) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034330, which also lists 2 linked publications.
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 16 Mar 2022.