SOCIAL_HF: Improving Social Frailty Through Interactive Learning

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Heart Failure

Treatments: Behavioral: SOCIAL_HF; Other: Self-study heart failure self-care manual

Study type: Interventional

Funder types: Other

Identifiers

NCT07234565

UW 25-387

Details and patient eligibility

About

The goal of this clinical trial is to learn whether the WeChat-based program "Social Optimization Chat for Interactive Learning for Heart Failure" (SOCIAL_HF) can improve social frailty in elderly patients with heart failure. The main questions it aims to answer are:

Can a 6-week WeChat online group interactive learning program (SOCIAL_HF) improve social frailty? Does the intervention enhance self-care abilities, social participation, and perceived social support? Researchers will compare SOCIAL_HF to usual care (self-study heart failure self-care manual) to assess whether SOCIAL_HF can improve social functioning.

Participants will:

Engage in weekly WeChat video meetings for six weeks (Participate in peer sharing and collaborative tasks).

Complete daily health task check-ins. Access online self-care resources.

Full description

Background: Patients with heart failure often face challenges such as shortness of breath, fatigue, and decline in daily functioning, significantly affecting their social activities and resource access, leading to social frailty. Research indicates that social frailty not only lowers quality of life but may also negatively impact survival outcomes. However, effective interventions addressing this issue remain scarce.

Aims: This study aims to improve social frailty among heart failure patients by enhancing social resources and promoting social activities. The specific objective is to evaluate the effectiveness of a 6-week WeChat online group interactive learning program (SOCIAL_HF), which is designed to increase participant interaction and social networks, thereby improving self-care abilities and breaking the vicious cycle of social frailty.

Methods: This study will be a two-arm, single-blind, randomized controlled trial (RCT), with a planned recruitment of 208 participants. The study comprises two phases: a feasibility study and a larger-scale RCT. Both phases will use the same recruitment and intervention procedures, with the main differences being the timepoints of follow-ups. Recruitment will occur through face-to-face interviews at multiple hospitals in Shanghai, with eligible participants randomly assigned to either the control group (usual care) or the 6-week intervention group in a 1:1 ratio. The random sequence will be generated by an independent research assistant using a computer-based randomization program. The generated numbers will be placed in opaque envelopes and allocated sequentially by the PI on-site. The intervention will include weekly WeChat video meetings, peer sharing, collaborative tasks, and health goal reviews, as well as daily health task check-ins and access to online self-care resources. The control group will establish a WeChat connection with the research assistants and receive standard care, which includes a health education manual. However, they will not participate in group learning or discussions.

During the feasibility study phase, participants will undergo primary and secondary outcome assessments at baseline and immediately post-intervention, conducted by independent research assistants. A mixed-methods approach will be employed to assess feasibility, including quantitative and qualitative analyses to evaluate recruitment status, attendance, and retention rates. Additionally, one-on-one semi-structured interviews will be conducted to determine the appropriateness and acceptability of the intervention measures. In the large-scale RCT phase, participants will receive outcome assessments at baseline, immediately post-intervention, and three months after the intervention to evaluate its maintenance effects on primary and secondary outcomes.

Outcomes: The primary outcome is social frailty, and the secondary outcome is perceived social support, social participation, and self-care.

Enrollment: 208 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 60 years old and above;
2. Live in the community;
3. a definitive diagnosis of heart failure based on the Framingham Heart Failure Diagnostic Criteria;
4. a diagnosis of heart failure for 6 months or longer;
5. evidence of social pre-frailty or frailty, determined by the SFS-8 score ≥ 2; (6) possession of a smartphone and experience using WeChat;

(7) be able to read and write Chinese.

Exclusion criteria

1. severe cognitive impairment or dementia;
2. known mental illnesses;
3. any communication barriers may hinder participation in SOCIAL_HF, such as illiteracy, reading disabilities, speak local dialect only, and difficulties in language comprehension;
4. any sensory impairments that may affect learning or interaction with others on WeChat, including untreated severe hearing loss and vision impairments；
5. are currently participating in other intervention studies.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Usual care

Active Comparator group

Description:

One educational booklet

Treatment:

Other: Self-study heart failure self-care manual

SOCIAL_HF

Experimental group

Description:

One educational booklet; one session per week, each lasting one hour, with two sessions in the final week, totaling seven online group sessions; daily 0.5-hour WeChat group chats, five days a week.

Treatment:

Behavioral: SOCIAL_HF