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

NCT03034330 | Completed

• 1 other identifier: UW16-1019
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

informal care; empowerment; family-focused intervention; stroke rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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).

  6 months

Secondary Outcomes (19)

• Caregiver Burden measuewd by the Cantonese Short Version of Zarit Burden Interview (questionnaire)

  6 months

• Depressive symptoms measured by the The Patient Health Questionnaire-9 (PHQ-9) (Questionnaire)

  6 months

• Ambivalence between caregivers and care receivers measured by the Caregiving Ambivalence Scale (Questionnaire)

  6 months

• The mental or affective state of caregivers in relation to stressful caregiving experience measured by the Positive Aspects of Caregiving (PAC) (Questionnaire)

  6 months

• Social network of caregivers measured by the Lubben Social Network Scale (LSNS) (Questionnaire)

  6 months

Study Arms (2)

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.

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.

Other: Volunteer Support Psychoeducation

Interventions

Two-Tier Stroke Family Empowerment 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.

Two-Tier Stroke Family Empowerment

Volunteer Support Psychoeducation 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.

Volunteer Support Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Sau Po Center on Ageing HKU

Hong Kong, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 34813082 DERIVED

• 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.

  PMID: 34047707 DERIVED

MeSH Terms

Conditions

Stroke; Empowerment

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Lou Vivian, Vivian

  Sau Po Center on Ageing, HKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sau Po Center on Ageing, Faculty of Social Science

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 27, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)