A Two-Tier Care Management Program to Empower Stroke Caregivers in Hong Kong

NCT ID: NCT03034330

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-03-31

Brief 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. To examine the effectiveness of the proposed family-based intervention to improve family, caregiver, and service outcome.

2. 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Two-Tier Stroke Family Empowerment

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.

Group Type: EXPERIMENTAL

Two-Tier Stroke Family Empowerment

Intervention Type: OTHER

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 Psychoeducation

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.

Group Type: ACTIVE_COMPARATOR

Volunteer Support Psychoeducation

Intervention Type: OTHER

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.

Interventions

Two-Tier Stroke Family Empowerment

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.

Intervention Type: OTHER

Volunteer Support Psychoeducation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A stroke caregiver is eligible to participate in the study if:

1. He / She is a Chinese adult aged 18 or above;

2. 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;

3. He / She provides care or being with the stroke survivor for no less than two hours per day after discharge from the acute hospital;

4. 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:

1. He / She is a Chinese adult aged 50 or above;

2. He / She has been discharged from the acute hospital for no more than 6 months;

3. His / Her family caregiver participates in this study;

4. He/ She is able to communicate with interventionists and interviewers;

5. 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.

Exclusion Criteria

• A stroke caregiver will be excluded from participation if:

1. His / Her family member has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke;

2. His / Her family member with stroke is residing in a residential care facility after discharge from the acute hospital;

3. He / She is diagnosed as having Alzheimer's disease or other dementias;

4. He / She is unable to understand Cantonese.

A stroke survivor is not eligible to participate in the study if:

1. He / She is residing in a residential care facility after discharge from the acute hospital;

2. He/ She has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke;

3. His / Her family caregiver refuses to participate in this study;

4. He/ She is not able to communicate with interventionists and interviewers;

5. He/ She is not competent to give written informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Vivian W.Q. Lou

Director, Sau Po Center on Ageing, Faculty of Social Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lou Vivian, Vivian

Role: PRINCIPAL_INVESTIGATOR

Sau Po Center on Ageing, HKU

Locations

Sau Po Center on Ageing HKU

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 34813082 (View on PubMed)

Lou 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.

Reference Type: DERIVED

PMID: 34047707 (View on PubMed)

Other Identifiers

UW16-1019

Identifier Type: -

Identifier Source: org_study_id