一项针对中风幸存者家庭照顾者的两层家庭导向干预措施在增强其家庭功能和照顾能力方面的效果：一项随机对照试验方案

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.

作者信息

Lou Vivian Weiqun, Tang Jennifer Yee Man, Lau Gary Kui Kai, Lum Terry Yat Sang, Fong Kenneth, Ko Rachel Wai Tung, Cheng Clio Yuen Man, Fu Joyce Yinqi, Chow Eddie Siu Lun, Chu Angus Chun Kwok, Hui Elsie, Ng Winnie Wing Ling, Chan Felix Hon Wai, Luk C C, Kwok T K

机构信息

Sau Po Centre on Ageing, The University of Hong Kong, Hong Kong, Hong Kong.

Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, Hong Kong.

出版信息

JMIR Res Protoc. 2021 May 28;10(5):e16703. doi: 10.2196/16703.

DOI:10.2196/16703

PMID:34047707

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8196356/

Abstract

BACKGROUND

Stroke has profound impacts on families. Often, family members, including stroke survivors and the person who takes up the role of the primary caregiver, would encounter demands on finances, rehabilitation arrangement, and even conflicts. Hence, a family-oriented intervention is expected to enable families to rebuild internal and external resources to achieve optimal rehabilitation and community reintegration.

OBJECTIVE

This study aims to describe a design of a two-tier family-oriented care management intervention for enhancing the family functioning and care capacity of the caregivers of stroke survivors.

METHODS

The two-tier care management intervention was guided by a standardized protocol conducted by trained professional care managers (first tier) with the support of trained volunteers (second tier), which lasted for 8-12 weeks. Participants were recruited through collaborating hospitals according to inclusion and exclusion criteria. In order to examine the effectiveness and cost-effectiveness of the two-tier care management intervention, a two-arm randomization multicenter study was designed, including an active comparison group, which was guided by a standardized protocol conducted by trained volunteers. Dyadic participants, including both stroke survivors and their primary caregivers for both groups, were invited to participate in a questionnaire survey using standardized and purposefully developed measures 3 times: before the intervention, immediately after the intervention, and 2 months after the intervention. The primary outcome was family functioning measured by the Family Role Performance Scale and Family Assessment Device-General Functioning Scale. The secondary outcomes included caregiving burden, depressive symptoms, care management strategies, and the incremental cost-effectiveness ratio.

RESULTS

Recruitment began in January 2017 and was completed at the end of April 2019. Data collection was completed at the end of March 2020. As of March 2020, enrollment has been completed (n=264 stroke caregivers). A total of 200 participants completed the baseline questionnaires. We aim to publish the results by mid-2021.

CONCLUSIONS

This study successfully developed a two-tier care management protocol that aims to enhance the family functioning of the caregivers of stroke survivors. Guided by a standardized protocol, this family-oriented two-tier intervention protocol was found to be feasible among Chinese families.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03034330; https://ichgcp.net/clinical-trials-registry/NCT03034330.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/16703.

摘要

背景

中风对家庭有深远影响。通常，家庭成员，包括中风幸存者和承担主要照顾者角色的人，会在经济、康复安排等方面面临需求，甚至会产生冲突。因此，一种以家庭为导向的干预措施有望使家庭重建内部和外部资源，以实现最佳康复和重新融入社区。

目的

本研究旨在描述一种两层式以家庭为导向的护理管理干预设计，以提高中风幸存者照顾者的家庭功能和护理能力。

方法

两层式护理管理干预由经过培训的专业护理经理（第一层）在经过培训的志愿者（第二层）的支持下按照标准化方案进行，为期8至12周。根据纳入和排除标准，通过合作医院招募参与者。为了检验两层式护理管理干预的有效性和成本效益，设计了一项双臂随机多中心研究，包括一个积极对照组，该组由经过培训的志愿者按照标准化方案进行指导。两组的二元参与者，包括中风幸存者及其主要照顾者，被邀请使用标准化且专门开发的测量工具进行3次问卷调查：干预前、干预后立即以及干预后两个月。主要结局是通过家庭角色表现量表和家庭评估设备-总体功能量表测量的家庭功能。次要结局包括护理负担、抑郁症状、护理管理策略以及增量成本效益比。