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