Heart FailureSOCIAL_HFNCT07234565
SOCIAL_HF: Improving Social Frailty Through Interactive Learning
A study testing SOCIAL_HF and Self-study heart failure self-care manual in people with Heart Failure, run by The University of Hong Kong at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SOCIAL_HF and Self-study heart failure self-care manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 3 sitesChina
- Study dates
- 15 Sep 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- be able to read and write Chinese.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Doris Yu contact
China3 sites, 3 recruiting
- Not yet recruiting
Fudan University Affiliated Huadong Hospital
Shanghai
Miao, 86 15902124050, marymiao@connect.hku.hk
- Not yet recruiting
Shanghai Baoshan District Integrated Traditional Chinese and Western Medicine Hospital
Shanghai
LIU, 86 15921648146, shuimuzhenyi0529@163.com
- Recruiting
Shanghai Jiao Tong University School of Medicine Affiliated Songjiang Hospital
Shanghai
MIAO, 86 13391385030, marymiao@connect.hku.hk
About this study
Official title: The Effects of "Social Optimization Chat for Interactive Learning for Heart Failure" (SOCIAL_HF) on Improving Social Frailty: A Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- SOCIAL_HF, Self-study heart failure self-care manual
- Keywords
- Social frailty, Heart Failure, WeChat-based, Interactive learning, Self-care, Social support, Social participation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCIAL_HFBehavioural
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.
Self-study heart failure self-care manualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | One educational booklet Receives: 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. Receives: Behavioral: SOCIAL_HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Perceived social support as an indicator of social resources will be assessed by the Chinese Mandarin version of the Medical Outcomes Study Social Support Survey (MOS-SSS-CM), which consists of 19 items across four dimensions: tangible support (4 items), informational and emotional support (8 items), positive social interaction (4 items), and affectionate support (3 items). Each item is rated on a 5-point Likert scale, with higher scores indicating better support.
Measured: 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
Social participation serves as an indicator of engagement in social activities. The Impact on Participation and Autonomy Questionnaire (IPA), which is a self-report instrument that measures people's perceptions of participation and autonomy, will be used to evaluate the social participation of older adults with heart failure. The original scale has a Cronbach's α ranging from 0.81 to 0.9. The Chinese version of the questionnaire was translated by Li et al [48]. Comprising 25 items, the scale is organized into four distinct dimensions: autonomy indoors (7 items), family role (7 items), autonomy outdoors (5 items), and social life (6 items). A 5-point Likert scale is utilized, with "a lot" receiving 0 points and "a little" receiving 4 points. Scores can range from 0 to 100, where a higher score reflects a lower level of social participation.
Measured: 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
Self-care will be assessed by the Chinese version of the Self-care Heart Failure Index version 7.2 (SCHFI v7.2-C), which comprises 29 items across three dimensions. Scores range from 0 to 100, with 70 or above indicating adequate self-care.
Measured: Feasibility study phase: At enrollment and immediately post-intervention. During full RCT phase: At enrollment, immediately post-intervention and 3-month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start15 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miao MIAO, The University of Hong Kong
- Investigators
- Miao Miao, MN, RN, Principal investigator, School of Nursing, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234565
- Sponsor's protocol ID
- UW 25-387
- Acronym
- SOCIAL_HF
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the following specific individual participant data (IPD): age, gender, residential status, marital status, medical history, and targeted outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of "Social Optimization Chat for Interactive Learning for Heart Failure" (SOCIAL_HF) on Improving Social Frailty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07234565
- Acronym / sponsor ID
- SOCIAL_HF / UW 25-387
- Conditions
- Heart Failure
- Keywords
- Social frailty, Heart Failure, WeChat-based, Interactive learning, Self-care, Social support, Social participation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Self-study heart failure self-care manualOne educational booklet |
| SOCIAL_HF | Experimental | Behavioral: SOCIAL_HFOne 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOCIAL_HFParticipants 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. | Behavioural | SOCIAL_HF |
| Self-study heart failure self-care manualThe 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. | Other | Usual care |
Primary outcome
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.
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).
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. We will share the following specific individual participant data (IPD): age, gender, residential status, marital status, medical history, and targeted outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doris Yu contact
Miao Miao, MN, RN principal investigator
School of Nursing, University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOCIAL_HF and Self-study heart failure self-care manual in people with Heart Failure, run by The University of Hong Kong at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miao Miao (852-51697980, marymiao@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.