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 (Preprint)

Abstract

BACKGROUND Stroke brings about abrupt and immense changes to stroke families’ dynamics and responsibilities. Adaptation to new family roles is challenging, as support for caregivers of stoke survivors is minimal, presenting a major obstacle towards restoring family functioning and maximizing care capacity. OBJECTIVE This study aims to implement and examine the effectiveness of a two-tier family- oriented intervention involving care managers and volunteers for enhancing family functioning and care capacity of family caregivers of stroke survivors. METHODS This is a multicenter, two-armed, randomized, controlled study (intervention group, n=150; control group, n=150). Following case referral from hospital, family caregivers of stroke survivors and stroke survivors provide informed consent and undergo initial screening. Caregivers report significant caregiver burden, and/or depressive mood, and/or family dysfunctioning are randomly assigned to undergo two-tier family-oriented intervention (intervention group) or psychoeducation (control group). The primary outcome is the change in i) family role performance, ii) family caregiver conflict, iii) care management strategies, and iv) general family functioning from baseline to 2 weeks and 2 months after completion of intervention. RESULTS This study began in January 2017 and is being conducted at three participating facilities in Hong Kong. CONCLUSIONS This study will examine the effectiveness of a two-tier family- oriented intervention in enhancing family functioning and care capacity of family caregivers of stroke survivors. Through this study, we expect that this intervention can fill the service gap in the current stroke care system and serves as an important basis on which future evidence-based programs supporting family caregivers of stroke survivors could develop. CLINICALTRIAL ClinicalTrials.gov NCT03034330; https://ichgcp.net/clinical-trials-registry/NCT03034330