NCT07234565

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
17mo left

Started Sep 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Sep 2027

Study Start

First participant enrolled

September 15, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

November 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 21, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

Social frailtyHeart FailureWeChat-basedInteractive learningSelf-careSocial supportSocial participation

Outcome Measures

Primary Outcomes (1)

  • Social frailty

    Social frailty will be assessed by using Social Frailty Scale-8 item developed by Pek in Singapore. It consists of eight questions covering whether they visit friends sometimes, seek advice from family and friends, have people they can trust, go out less frequently, eat alone, have financial difficulties, live alone, talk to someone every day. It uses a dichotomous scoring method with a total score ranging from 0 to 8 points. A score of 0-1 indicates social non-frailty (SNF), 2-3 indicates social pre-frailty (SPF), and ≥4 indicates social frailty (SF).

    Feasibility study phase: At enrollment and immediately post-intervention. During full RCT phase: At enrollment, immediately post-intervention and 3-month post-intervention.

Secondary Outcomes (3)

  • Perceived social support

    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

    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

    Feasibility study phase: At enrollment and immediately post-intervention. During full RCT phase: At enrollment, immediately post-intervention and 3-month post-intervention.

Other Outcomes (2)

  • Feasibility indicators

    Recruitment Status: Assessed at baseline. Attendance Rate: Monitored during the intervention phase (from enrollment through the 6-week intervention period). Retention Rate: Through study completion, an average of 6 months.

  • Appropriateness, practicality, and acceptability of the intervention measures

    Within two weeks after completion of the intervention

Study Arms (2)

Usual care

ACTIVE COMPARATOR

One educational booklet

Other: Self-study heart failure self-care manual

SOCIAL_HF

EXPERIMENTAL

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.

Behavioral: SOCIAL_HF

Interventions

SOCIAL_HFBEHAVIORAL

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 chat interactions will revolve around completing group contract tasks, weekly quizzes, and daily sharing. Additionally, participants will have access to an online self-care resource hub on the WeChat platform for reference and use.

SOCIAL_HF

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.

Usual care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fudan University Affiliated Huadong Hospital

Shanghai, China

NOT YET RECRUITING

Shanghai Baoshan District Integrated Traditional Chinese and Western Medicine Hospital

Shanghai, China

NOT YET RECRUITING

Shanghai Jiao Tong University School of Medicine Affiliated Songjiang Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Miao Miao, MN, RN

    School of Nursing, University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2025

First Posted

November 18, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

November 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

We will share the following specific individual participant data (IPD): age, gender, residential status, marital status, medical history, and targeted outcomes.

Shared Documents
STUDY PROTOCOL
Time Frame
The individual participant data (IPD) that underlie the results reported in this article will be made available upon acceptance of the manuscript for publication. The data will be accessible for a minimum of 5 years from the date of publication.
Access Criteria
The de-identified IPD will be available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Access requests will be reviewed by a designated data access committee (or by the corresponding author) to ensure the proposed use is scientifically valid and does not conflict with the original informed consent.

Locations