JMIR Publications

ABSTRACT

Background:

Stroke is the fourth leading cause of death in Hong Kong, it impacts the whole family, not only patients. While stroke can have negative physical, psychological, and cognitive impacts ton patients, studies have found that stroke also affects caregivers. However, these studies were concerned more on either patients or caregivers independently. Adaptation to new family roles is challenging, as support for caregivers of stoke survivors is individual-targeted rather than family-oriented. We designed a randomized controlled trial protocol to assess the effectiveness of a two-tier family-oriented intervention in enhancing family functioning family caregivers of stroke survivors in Hong Kong.

Objective:

This study aims to implement and examine the effectiveness of a two-tier family-oriented intervention involving care managers (first tier) and volunteers (second tier) in enhancing family functioning of family caregivers of stroke survivors. We hypothesized that a two-tier family-oriented stroke caregiver intervention will enhance the family functioning and care capacity of stroke caregivers as compared to the volunteer-led active control.

Methods:

This is a two-arm, multicenter, randomized controlled trial that compares care manager-led two-tier intervention group and volunteer-led active control group, each consisting of 150 participants (n=300) taking care of a family member who had stroke. We will evaluate the effectiveness of a two to three months intervention. The primary outcome of family functioning will be measured using the Family Role Performance Scale, Care Management Strategies Scale, Family Caregiver Conflict Scale and Family Assessment Device-General Functioning Scale. Secondary outcomes will be assessed with the Cantonese Short Version of Zarit Burden Interview, Patient Health Questionnaire-9 and Caregiving Ambivalence Scale. All measures will be assessed at the start (baseline), two weeks (first follow-up), and two months after the intervention (second follow-up). Participants in the intervention group are expected to increase family functioning over time as compared to participants in the active control group.

Results:

This study began recruiting in January 2017 and recruitment was completed at the end of April 2019. Data collection and dataset construction was completed by the end of March 2020. A total of 264 cases were randomly allocated, with 134 cases in the intervention group and 130 in the active control group. Among them, 200 cases completed the baseline questionnaire.

Conclusions:

This study is unique in that it examines the effectiveness of a two-tier family-oriented intervention in enhancing family functioning of family caregivers of stroke survivors in Hong Kong. Through this study, we expect that this intervention model can fill the existing service gap in stroke care system and serves as an important basis on which future evidence-based programs supporting family caregivers of stroke survivors could develop. Clinical Trial: This study has been registered on ClinicalTrials.gov NCT03034330; https://ichgcp.net/clinical-trials-registry/NCT03034330 on January 1, 2017 before the start of study.