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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Stroke

Treatments: Other: Two-Tier Stroke Family Empowerment; Other: Volunteer Support Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT03034330

UW16-1019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Two-Tier Stroke Family Empowerment

Experimental group

Description:

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.

Treatment:

Other: Two-Tier Stroke Family Empowerment

Volunteer Support Psychoeducation

Active Comparator group

Description:

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.

Treatment:

Other: Volunteer Support Psychoeducation