Clinical trial NCT03034330: A Two-Tier Care Management Program to Empower Stroke Caregivers in Hong Kong
Official title: A Two-Tier Care Management Program to Empower Stroke Caregivers in Hong Kong: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: informal care
empowerment
family-focused intervention
stroke rehabilitation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Family Role Performance measured by the Family Role Performance Scale (Questionnaire)
timeFrame: 6 months
measure: Care Management Strategies measured by the Care Management Strategies Scale (Questionnaire)
timeFrame: 6 months
measure: Family Caregiver Conflict measured by Family Caregiver Conflict Scale (FCCS) (Questionnaire)
timeFrame: 6 months
measure: Family Function measured by the Family Assessment Device-General Functioning Scale (FAD-GF) (Questionnaire)
timeFrame: 6 months
Secondary outcomes:
measure: Caregiver Burden measuewd by the Cantonese Short Version of Zarit Burden Interview (questionnaire)
timeFrame: 6 months
measure: Depressive symptoms measured by the The Patient Health Questionnaire-9 (PHQ-9) (Questionnaire)
timeFrame: 6 months
measure: Ambivalence between caregivers and care receivers measured by the Caregiving Ambivalence Scale (Questionnaire)
timeFrame: 6 months
measure: The mental or affective state of caregivers in relation to stressful caregiving experience measured by the Positive Aspects of Caregiving (PAC) (Questionnaire)
timeFrame: 6 months
measure: Social network of caregivers measured by the Lubben Social Network Scale (LSNS) (Questionnaire)
timeFrame: 6 months
measure: Contemporary filial piety of caregivers measured by the Contemporary Filial Piety Scale (CFPS-10) (Questionnaire)
timeFrame: 6 months
measure: Stroke knowledge of caregivers measured by the Stroke Knowledge Test (SKT) (Questionnaire)
timeFrame: 6 months
measure: Self-rated Health measured by a question to rate their health (Questionnaire)
timeFrame: 6 months
measure: Health-related quality of life measured by SF-12 Health Survey (SF-12) (Questionnaire)
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: The rate of inpatient hospital admission of stroke survivors
timeFrame: 6 months
measure: Number of specialist outpatient received by stroke survivors
timeFrame: 6 months
measure: Number of accident and emergency service received by stroke survivors
timeFrame: 6 months
measure: Number of medicines received by stroke survivors
timeFrame: 6 months
measure: Number of hospital rehabilitation service received by stroke survivors
timeFrame: 6 months
measure: Number of home care service received by stroke survivors
timeFrame: 6 months
measure: Number of day care service received by stroke survivors
timeFrame: 6 months
measure: Number of community rehabilitation service received by stroke survivors
timeFrame: 6 months
measure: Number of residential care service received by stroke survivors(admission after study intake)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sau Po Center on Ageing HKU
Study officials:
affiliation: Sau Po Center on Ageing, HKU
name: Lou Vivian, Vivian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.