SOCIAL_HF: Improving Social Frailty Through Interactive Learning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SOCIAL_HF, Self-study heart failure self-care manual.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of "Social Optimization Chat for Interactive Learning for Heart Failure" (SOCIAL_HF) on Improving Social Frailty: A Randomized Controlled Trial
Overview
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.
Detailed 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.
Interventions
- Behavioral SOCIAL_HF
Participants will engage in a 6-week, WeChat-based group learning program called SOCIAL\_HF, focused on heart failure self-care. This program comprises two key components: structured real-time interactive learning and ongoing synchronous support. Real-time interactive learning will be conducted through WeChat video group meetings weekly, featuring peer sharing, problem-solving collaborative tasks, health goal setting, progress sharing, and the establishment of group contracts. Daily synchronous - Other Self-study heart failure self-care manual
The control group will establish a WeChat connection with PI and receive standard care, which includes a health education manual. However, they will not participate in group learning or discussions. They can consult with research assistants via WeChat for any questions they may have, but the researchers will only provide explanations related to the health education manual and will not offer additional educational resources or group interactions.
Primary outcome measures
- Social frailty [Time frame: Feasibility study phase: At enrollment and immediately post-intervention. During full RCT phase: At enrollment, immediately post-intervention and 3-month post-intervention.]
Secondary outcome measures (3)
- Perceived social support [Time frame: Feasibility study phase: At enrollment and immediately post-intervention. During full RCT phase: At enrollment, immediately post-intervention and 3-month post-intervention.]
- Social participation [Time frame: Feasibility study phase: At enrollment and immediately post-intervention. During full RCT phase: At enrollment, immediately post-intervention and 3-month post-intervention.]
- Self-care [Time frame: Feasibility study phase: At enrollment and immediately post-intervention. During full RCT phase: At enrollment, immediately post-intervention and 3-month post-intervention.]
Eligibility criteria
Inclusion criteria
- 60 years old and above;
- Live in the community;
- a definitive diagnosis of heart failure based on the Framingham Heart Failure Diagnostic Criteria;
- a diagnosis of heart failure for 6 months or longer;
- 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
- severe cognitive impairment or dementia;
- known mental illnesses;
- any communication barriers may hinder participation in SOCIAL\_HF, such as illiteracy, reading disabilities, speak local dialect only, and difficulties in language comprehension;
- any sensory impairments that may affect learning or interaction with others on WeChat, including untreated severe hearing loss and vision impairments；
- are currently participating in other intervention studies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 3 centers
- Fudan University Affiliated Huadong Hospital — Shanghai
- Shanghai Baoshan District Integrated Traditional Chinese and Western Medicine Hospital — Shanghai
- Shanghai Jiao Tong University School of Medicine Affiliated Songjiang Hospital — Shanghai
Identifiers
NCT: NCT07234565 · UW 25-387