Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 May 28;10(5):e16703.
doi: 10.2196/16703.

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

Vivian Weiqun Lou #  1   2 , Jennifer Yee Man Tang  1 , Gary Kui Kai Lau  3   4 , Terry Yat Sang Lum  1   2 , Kenneth Fong  5 , Rachel Wai Tung Ko  1 , Clio Yuen Man Cheng  1 , Joyce Yinqi Fu  1 , Eddie Siu Lun Chow  6 , Angus Chun Kwok Chu  6 , Elsie Hui  7 , Winnie Wing Ling Ng  7 , Felix Hon Wai Chan  3   8 , C C Luk  9 , T K Kwok  10
Affiliations

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

Vivian Weiqun Lou et al. JMIR Res Protoc. .

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.

Keywords: family caregivers; family functioning; randomized controlled trial; stroke survivors; two-tier family-oriented intervention.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
CONSORT flow diagram of the randomized controlled trial with 2 groups. HK: Hong Kong.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Han B, Haley W E. Family caregiving for patients with stroke. Review and analysis. Stroke. 1999 Jul;30(7):1478–85. doi: 10.1161/01.str.30.7.1478. - DOI - PubMed
    1. Salter K, Zettler Laura, Foley Norine, Teasell Robert. Impact of caring for individuals with stroke on perceived physical health of informal caregivers. Disabil Rehabil. 2010;32(4):273–81. doi: 10.3109/09638280903114394. - DOI - PubMed
    1. Clark Patricia C, Dunbar Sandra B, Shields Cleveland G, Viswanathan Bindu, Aycock Dawn M, Wolf Steven L. Influence of stroke survivor characteristics and family conflict surrounding recovery on caregivers' mental and physical health. Nurs Res. 2004;53(6):406–13. doi: 10.1097/00006199-200411000-00009. - DOI - PubMed
    1. Dede DE. The role of family functioning in the burden of caregivers of patients undergoing rehabilitation after suffering first cerebrovascular accident. Diss Abs Int. 1993. [2021-05-17]. https://www.elibrary.ru/item.asp?id=5779342.
    1. Grant Joan S, Clay Olivio J, Keltner Norman L, Haley William E, Wadley Virginia G, Perkins Martinique M, Roth David L. Does caregiver well-being predict stroke survivor depressive symptoms? A mediation analysis. Top Stroke Rehabil. 2013;20(1):44–51. doi: 10.1310/tsr2001-44. http://europepmc.org/abstract/MED/23340070 - DOI - PMC - PubMed

Associated data