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Title: 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
Authors: Lou, VW
Tang, JYM
Lau, GKK
Lum, TYS
Fong, K 
Cheng, CYM
Fu, JY
Chow, ESL
Chu, ACK
Hui, E
Chan, FHW
Luk, CC
Kwok, TK
Issue Date: May-2021
Source: JMIR research protocols, 28 May 2021, v. 10, no. 5, e16703
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.
Keywords: Family caregivers
Family functioning
Randomized controlled trial
Stroke survivors
Two-tier family-oriented intervention
Publisher: JMIR Publications, Inc.
Journal: JMIR research protocols 
EISSN: 1929-0748
DOI: 10.2196/16703
Rights: ¬©Vivian Weiqun Lou, Jennifer Yee Man Tang, Gary Kui Kai Lau, Terry Yat Sang Lum, Kenneth Fong, Rachel Wai Tung Ko, Clio Yuen Man Cheng, Joyce Yinqi Fu, Eddie Siu Lun Chow, Angus Chun Kwok Chu, Elsie Hui, Winnie Wing Ling Ng, Felix Hon Wai Chan, C C Luk, T K Kwok. Originally published in JMIR Research Protocols (, 28.05.2021.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on, as well as this copyright and license information must be included.
The following publication Lou VW, Tang JYM, Lau GKK, Lum TYS, Fong K, Ko RWT, Cheng CYM, Fu JY, Chow ESL, Chu ACK, Hui E, Ng WWL, Chan FHW, Luk CC, Kwok TK 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 JMIR Res Protoc 2021;10(5):e16703 is available at
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