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.
- Two-Tier Stroke Family Empowerment Other
Intervention Desc: 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. ARM 1: Kind: Experimental Label: Two-Tier Stroke Family Empowerment 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.
- Volunteer Support Psychoeducation Other
Intervention Desc: 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. ARM 1: Kind: Experimental Label: Volunteer Support Psychoeducation 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.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Family Role Performance measured by the Family Role Performance Scale (Questionnaire)||6 months|
|Primary||Care Management Strategies measured by the Care Management Strategies Scale (Questionnaire)||6 months|
|Primary||Family Caregiver Conflict measured by Family Caregiver Conflict Scale (FCCS) (Questionnaire)||6 months|
|Primary||Family Function measured by the Family Assessment Device-General Functioning Scale (FAD-GF) (Questionnaire)||6 months|
|Secondary||Caregiver Burden measuewd by the Cantonese Short Version of Zarit Burden Interview (questionnaire)||6 months|
|Secondary||Depressive symptoms measured by the The Patient Health Questionnaire-9 (PHQ-9) (Questionnaire)||6 months|
|Secondary||Ambivalence between caregivers and care receivers measured by the Caregiving Ambivalence Scale (Questionnaire)||6 months|
|Secondary||The mental or affective state of caregivers in relation to stressful caregiving experience measured by the Positive Aspects of Caregiving (PAC) (Questionnaire)||6 months|
|Secondary||Social network of caregivers measured by the Lubben Social Network Scale (LSNS) (Questionnaire)||6 months|
|Secondary||Contemporary filial piety of caregivers measured by the Contemporary Filial Piety Scale (CFPS-10) (Questionnaire)||6 months|
|Secondary||Stroke knowledge of caregivers measured by the Stroke Knowledge Test (SKT) (Questionnaire)||6 months|
|Secondary||Self-rated Health measured by a question to rate their health (Questionnaire)||6 months|
|Secondary||Health-related quality of life measured by SF-12 Health Survey (SF-12) (Questionnaire)||6 months|
|Secondary||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)||6 months|
|Secondary||The rate of inpatient hospital admission of stroke survivors||6 months|
|Secondary||Number of specialist outpatient received by stroke survivors||6 months|
|Secondary||Number of accident and emergency service received by stroke survivors||6 months|
|Secondary||Number of medicines received by stroke survivors||6 months|
|Secondary||Number of hospital rehabilitation service received by stroke survivors||6 months|
|Secondary||Number of home care service received by stroke survivors||6 months|
|Secondary||Number of day care service received by stroke survivors||6 months|
|Secondary||Number of community rehabilitation service received by stroke survivors||6 months|
|Secondary||Number of residential care service received by stroke survivors(admission after study intake)||6 months|