The Effects of "Social Optimization Chat for Interactive Learning for Heart Failure" (SOCIAL_HF) on Improving Social Frailty: A Randomized Controlled Trial
Phase: NA
Conditions: Heart Failure
Sponsor: The University of Hong Kong

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The Effects of “Social Optimization Chat for Interactive Learning for Heart Failure”
(SOCIAL_HF) on improving social frailty: A Randomized Controlled Trial
Principal investigator
Miss Miao MIAO, Phd candidate, School of Nursing, The University of Hong Kong
Co-investigators
Prof. Sau Fung Doris YU, Professor, School of Nursing, The University of Hong Kong
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Date: Aug 4, 2025

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1 Background
In the past decade, social frailty has gained attention due to the widespread recognition
of its close association with social health and healthy aging [1, 2]. It is perceived as a
vulnerable state resulting from the cumulative loss of social resources (including tangible
resources as well as interpersonal networks and interactions) in various domains, types,
and quantities, reflecting an individual's overall social health status [3]. Evidence
indicates that social frailty is prevalent among older adults, with a systematic review
revealing an overall prevalence of 21.1% (95% CI = 17.8–24.5%) in global communities,
making it more common than physical and cognitive frailty [4]. Furthermore, social frailty
has been linked to adverse health outcomes, including all-cause mortality (HR=1.96,
95% CI 1.20-3.19) and disability (OR=2.06, 95% CI 1.55-2.74) [5]. Longitudinal studies
have shown that social frailty influences physical frailty [6], cognitive decline[7, 8],
intrinsic capacity impairment[9], and depression [10] in older adults, suggesting it may
serve as an early indicator of health decline. Thus, actively preventing and reversing
social frailty could improve health outcomes and enhance healthy life expectancy.
Heart failure, a clinical syndrome characterized by abnormal cardiac output affecting
approximately 64 million people worldwide, poses a significant healthcare burden [11].
Patients
with
heart
failure
not
only
experience
debilitating
symptoms
such
as
breathlessness and fatigue but also face declining daily functioning and comorbidities
[12], which severely limit their social activities and access to resources [13, 14]，leading to
social frailty. As opportunities for interaction decrease, heart failure patients struggle to
obtain necessary social support and resources for effective self-care or [15, 16] to make
informed health decisions [17]. This further exacerbates their symptoms and disease
progression, creating a vicious cycle. In this context, the prevalence of social frailty in this
population is particularly concerning. For instance, a multicenter longitudinal study in
Japan found that social frailty affected up to 66% of hospitalized heart failure patients
aged 65 and older, predicting all-cause mortality and heart failure readmission [18].
Similarly, another Chinese cohort study involving 297 heart failure patients reported that
nearly 70% of hospitalized patients exhibited social frailty or pre-frailty. The risk of death
within six months post-discharge for those with social frailty or pre-frailty was 3.52 times
and 1.43 times higher, respectively, compared to patients without social frailty [19]. Given
the high prevalence of social frailty among elderly patients with heart failure and its
detrimental impact on health outcomes, there is an urgent need for effective interventions.
By enhancing social resources and interactions, patients can be empowered to
proactively manage their symptoms, thereby potentially breaking the cycle of social
frailty.
Social interaction activities based on Information and Communication Technologies
(ICTs) have the potential to enhance the social resources and participation of older adults
with heart failure. A systematic review indicates that ICT technologies, represented by
touchscreen devices and social networking services (SNS), positively impact social

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participation among older adults in the community. They empower older individuals to
initiate or engage in interactions by sharing photos or participating in video calls with
family, friends, or peers [20]. Through these social interactions, older adults can access
news, health information, and other valuable resources, becoming important sources of
social support, especially when mobility is limited [21]. Furthermore, another systematic
review suggested that ICT-based social interventions, such as training older adults to
use the internet and computers for social purposes, video conferencing, robots care, and
conversational agents, can alleviate social isolation through expanding social networks,
increasing social connections, enhancing social support, and improving self-efficacy [22].
In fact, ICT has been widely applied among heart failure patients. SNS, e-health
platforms, and Mobile APPs [23-25] serve as platforms for disseminating health
management knowledge and enable remote disease monitoring through reminders for
symptom measurement and documentation. This encourages patients to adopt healthier
behaviors and fosters effective collaboration with healthcare providers [26]. However,
previous studies have mainly concentrated on the effects of these technologies on
medical activities and health outcomes, with little attention given to their influence on
social outcomes. While these technologies have the potential to integrate social activities,
there has been limited focus on strategies that actively promote social interaction.
Indeed, a previous RCT that utilized robotic pets to improve social frailty among
community residents did not report significant improvements. This suggests that ICTs
may serve primarily as a tool for creating opportunities for interaction and safe social
environments [27]. While they play an important role in providing basic social platforms,
effectively enhancing older adults' willingness and engagement in social activities still
requires the integration of effective social facilitation strategies. One promising approach
is gamification, which involves using game mechanics or elements in non-game contexts
to combine the desire for communication and achievement sharing with goal setting [28].
This strategy can effectively stimulate interaction and encourage proactive behavior. For
example, Marcus et al. [29] developed a cooperative daily task challenge game for heart
failure patients and their families, incorporating gamification concepts like badges,
leaderboards, levels, and points. This design fostered interactions with both internal and
external social networks through cooperation and competition. Moreover, a prospective
cohort study indicated that group-based empathy discussions can help enhance the
perception of social support [30]. The sense of belonging and acceptance of differences
that emerges during these group interactions allows individuals to benefit from social
activities, thereby contributing to sustained social participation [31, 32].
In summary, improving social frailty is a crucial strategy for promoting self-care and
health outcomes among heart failure patients. Based on the conceptual model of social
frailty, enhancing social resources and facilitating social activities are key targets for
addressing this issue. By integrating ICT-based social activities with strategies such as
gamification and group discussions, we have the opportunity to effectively improve
social frailty. Given that the causes of social frailty in heart failure patients are often
related to their disease symptoms, it is essential to provide knowledge and resources

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related to disease management within social activities. To address these needs, the
study aims to develop a program called “Social Optimization Chat for Interactive
Learning for HF” (SOCIAL_HF) and evaluate its effects on improving social frailty in older
adults with heart failure. The intervention focuses on implementing group-based
interactive learning through WeChat, incorporating strategies such as collaborative
games, quizzes, point systems, and leaderboards. These components are designed to
foster interaction and social network, thereby optimizing the social resources and
activities of heart failure patients, ultimately leading to improved social frailty. This study
will assess the feasibility, acceptability, and effects of SOCIAL_HF intervention.
2 Objectives and hypothesis
2.1 Objectives of the study
This study will comprise two parts: a feasibility study and a full randomized controlled
trial (RCT).
The feasibility study aims to:
a.
Develop the “Social Optimization Chat for Interactive Learning for HF” (SOCIAL_HF)
program to alleviate social frailty in older adults with heart failure.
b.
Evaluate the feasibility of the program, focusing on the practicality of the study
design, methods, and interventions, as well as the capacity for participant
recruitment.
c.
Assess the acceptability of the SOCIAL_HF intervention by exploring participants'
willingness, experiences, and perceptions regarding its practicality. This will help
identify areas for improvement to optimize the intervention.
d.
Collect
preliminary
data
on
social
frailty,
perceived
social
support,
social
participation, and self-care. This data will provide a foundation for sample size
calculations in future larger-scale studies.
The larger-scale RCT will aim to:
a.
Evaluate the immediate effects of the optimized SOCIAL_HF program on the primary
outcome of social frailty, as well as secondary outcomes of perceived social support,
social participation, and self-care.
b.
Assess
the
longer-term
effects
of
the
intervention
by determining
whether
improvements in social frailty, perceived social support, social participation, and
self-care are maintained at three months post-intervention.
2.2 Hypothesis
Participants in the intervention group receiving the SOCIAL_HF intervention will
demonstrate improvements in social frailty, perceived social support, social participation,
and self-care compared to those in the control group, with the potential for sustained
long-term effects.

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3 Study design
The study comprises two phases: a feasibility study and a larger-scale, randomized
controlled trial (RCT). This feasibility study employs a mixed-methods approach to
evaluate the feasibility, acceptability, and preliminary effects of a WeChat-based social
optimization chat for interactive learning for older patients with heart failure (SOCIAL_HF).
The SOCIAL_HF program in two study phases is designed as a two-arm parallel
randomized controlled trial with assessor blinding.Both phases will use the same
recruitment and intervention procedures, with the main differences being the frequency
of follow-ups and the measurement outcomes.
PI will recruit and screen participants face-to-face at hospitals in Shanghai, including
Shanghai Jiao Tong University School of Medicine Affiliated Songjiang Hospital,
Shanghai Baoshan District Integrated Traditional Chinese and Western Medicine Hospital,
Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital, and
Fudan University Affiliated Huadong Hospital. Eligible participants will be randomly
assigned to either the control group or the six-week online intervention group.
During the feasibility study phase, participants will receive baseline assessment by PI
on-site and undergo outcome assessments immediately after the intervention by a
investigator who was not involved in the initial allocation or intervention. Additionally,
some participants will be invited to participate in qualitative interviews. In the large-scale
randomized controlled trial phase, participants will also receive follow-up assessments
three months after the intervention to evaluate the maintenance effects of the
intervention.
3.1 Study setting and participants
This study will recruit participants from heart failure outpatient clinics and cardiology
wards. The feasibility study and the large-scale RCT will use the same inclusion and
exclusion criteria.
Individuals meeting the following criteria can participate in the study: (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 scale score
≥2; (6) possession of a smartphone and experience using WeChat; (7) be able to read
and write Chinese.
Individuals will be excluded if they have: (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

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learning or interaction with others on WeChat, including untreated severe hearing loss
and vision impairments or (5) are currently participating in other intervention studies.
PI will obtain informed consent and then collect demographic data and baseline outcome
variables from participants in a quiet consultation room, using a baseline data
questionnaire. The participants will then be randomly assigned to either the intervention
group or the control group in a 1:1 ratio. The random sequence will be generated by a
separate research assistant, not involved in recruitment, using a block randomization
method (with block sizes of 4, 6, or 8) to ensure balance between groups. The research
assistant will generate randomized group identifiers using computer-based
randomization program and print them on standard 2cm × 2cm paper. These group
identifiers will then be placed sequentially into opaque, sealed envelopes to maintain
confidentiality and randomness in the allocation process.
During the allocation, PI will sequentially open the envelopes to assign each participant
to either the intervention group or the control group. Participants in the intervention
group will be added to a pre-established WeChat group to receive SOCIAL_HF program.
Furthermore, PI will provide a brief explanation of the intervention content and tasks, as
well as guide participants in using WeChat. Participants' proficiency with WeChat will be
assessed through several key tests, including sending voice messages, sending images,
opening links, and answering video call invitations.
In contrast, participants in the control group will only connection with the research
assistants on WeChat and will not participate in the group activities. Post-test outcome
assessments will be conducted immediately after the completion of the assigned
intervention (T1), at 3 months (T2, only for the large-scale RCT) thereafter through
telephone, by the research assistants who is not involved in recruitment or the
intervention and who is unaware of the random allocation status.
Participants will receive a reward of 100 RMB upon completing the follow-up, as a token
of appreciation for their participation and support. The study will strictly follow the
Declaration of Helsinki. Ethics approvals will be sought from the Institutional Review
Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster and
the Ethics Committees of Shanghai Jiao Tong University School of Medicine Affiliated
Songjiang Hospital, Shanghai Baoshan District Traditional Chinese and Western Medicine
Hospital, Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's
Hospital, and Fudan University Affiliated Huadong Hospital.
3.2 sample size
For the two-arm feasibility study, the goal is to obtain an estimated effect size with small
standardized difference, targeting a 80% powered and a two-sided 5% significance level
for the main trial [33]. Accounting for a 20% dropout rate, each group is expected to
require 24 participants, resulting in a total of 48 participants.

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For the qualitative phase, sampling will be based on the variation range of social frailty.
Participants will be purposefully recruited from three groups: those within the 0 to 34th
percentile, the 35th to 68th percentile, and the 69th to 100th percentile of the social frailty
changes. Sample collection will continue until data saturation is achieved.
Using G*Power 3.1, we determined that a moderate effect size (Hedge's g = 0.54) from
previous meta-analyses justifies a conservative target effect size of 0.50 for primary and
secondary outcomes [21, 34]. With a significance level (α) of 0.05 and 80% power, the
required sample size for the large-scale RCT is 128. Factoring in a 20% dropout rate, we
aim to recruit 160 participants. The sample size will be adjusted based on this result from
the feasibility study. The expected total sample size for the entire program is currently
planned to be 208 participants.
3.3 Interventions
3.3.1 Theoretical framework of the intervention
Randall Collins' Interaction Ritual Chains Theory (IRC) [35] provides significant guidance
for constructing effective interventions in this study. This theory operates as a
micro-interaction analytical framework within sociology, placing a strong emphasis on
the fundamental roles of emotional energy and group solidarity in shaping social
interactions. The emergence of interaction rituals requires the fulfillment of four key
conditions: group gathering, bounded space, mutual focus of attention, and shared
emotional mood. These conditions align the group's attention, behavior, and emotions,
transforming individuals
into ritual
participants.
Together,
these
elements evoke
collective effervescence, a powerful and highly contagious group psychological state
that further enhances emotional and social interaction processes among participants [36,
37].
The outcomes of these rituals manifest in several ways. Firstly, group solidarity emerges
as a profound sense of belonging among members, helping to create a supportive social
network. Secondly, the presence of group symbols serves as constant reminders of
these relationships, enriching the group's identity. Additionally, individuals experience
feelings of morality, which reinforce shared values and cooperations, further solidifying
the group's cohesion. Finally, emotional energy develops as a lasting positive feeling that
promotes social interactions, making individuals more likely to engage with each other in
meaningful ways [38].
These outcomes collectively drive the dynamics of interaction within the group. Through
repeated interaction rituals, the elements of emotional energy, group solidarity, feelings
of morality, and group symbols continually reinforce one another, creating a robust
interaction chain that promotes the stability and evolution of social behaviors over time.

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Figure 1 Conceptual framework of the interactive ritual chain and corresponding
intervention components
The WeChat platform provides an ideal environment for conducting interaction rituals. It
creates a well-defined group for heart failure patients, their families, and nurses,
effectively promoting the exchange and sharing of resources. Within this safe space,
discussions and learning about heart failure self-care knowledge and symptom
management strategies can quickly capture the interest and attention of group members.
By sharing their feelings, achievements, and challenges related to heart failure self-care,
members can foster emotional resonance, thereby strengthening their connections with
one another. Thus, focusing on heart failure self-care as the theme for interactive learning
in a WeChat group meets the four essential conditions for initiating interaction rituals.
Figure 1 illustrates the conceptual framework of the interaction ritual chain and the
corresponding intervention components.
Furthermore, integrating gamification strategies will enhance individual participation and
initiative in interactive learning, activating the interactive ritual chain. For instance,
gamified elements such as points, leaderboards, online check-ins, and tangible rewards,
which are oriented towards achievement and progress, can significantly boost
participants' interest in learning and their intrinsic motivation. Additionally,
social-oriented gamified elements like turn-based games, problem-solving based team
cooperations and competitions can promote participants' engagement and enhance
their ability to overcome challenges, enabling them to maintain continuous interaction in
group learning and discussion [39, 40].

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3.3.2 Intervention group: SOCIAL_HF
The main goal of this experimental intervention is to enhance social interaction among
older adults with heart failure, thereby improving their social frailty. 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.
The objectives of these components include: (1) promoting participant-driven interaction
through shared
focus
and
emotions; (2) enhancing
and
reshaping participants'
perceptions of their social networks through cooperation and competition; and (3)
providing social support to empower heart failure self-care. Furthermore, the program
will implement gamification strategies, such as dynamic scoring, visual leaderboards,
and periodic achievement rewards, to motivate participant engagement. Table 1 shows
the weekly intervention structure.
Table1 Weekly intervention structure
Timing
Activity
Format
1 time/week
60-min video-based
group meeting
Group sharing and discussion
（Peer sharing + Cooperation + Goal
attainment follow-up+ group contract）
1 time/week
Quiz
Online 5 MCQs
5 time/week
Group task relay
Fixed relay tasks (according to group contract)
Random relay tasks (triggered by context, e.g.
holidays, weather changes, and trending
issues)
Ongoing
Resource hub
Online articles, videos, links and peer-shared
strategies
Structured real-time interactive learning
Structured real-time interactive learning will be led by facilitators who will organize and
guide participant interactions while providing knowledge and skills related to self-care.
Participants will be divided into groups of six and will meet weekly via WeChat video
conferences. There will be a total of seven sessions (see table 2), with the first six
centered on the three key processes of heart failure self-care: self-care maintenance,
symptom perception, and self-care management [41]. The goal of self-care maintenance

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is to enhance participants' medication adherence and promote a healthy lifestyle.
Symptom perception focuses on helping participants to consistently monitor their vital
signs, identify early changes, and understand the causes and implications of common
heart failure symptoms. In addition, self-care management aims to empower participants
by providing strategies to address early changes and guidance for making informed
decisions about the common symptoms.
Although the three self-care processes are intended to be mastered sequentially, the
participants are more likely to have shared experiences related to heart failure symptoms,
which can evoke common concerns and emotional connections. Therefore, the first
session will focus specifically on symptom perception, allowing participants to discuss
and recognize their shared experiences. The themes of sessions 2 to 4 will center on
self-care maintenance. During these sessions, participants will learn to develop
low-sodium dietary plans and safe exercise routines. They will also gain a deeper
understanding of the medications they are taking, including their purpose, potential side
effects and coping strategies. Sessions 5 and 6 will equip participants with essential
skills to identify early physical changes and understand the underlying causes of their
symptoms. They will master effective management strategies, such as assessing the
urgency of different symptoms and learning how to adjust medications or implement fluid
restrictions to alleviate symptoms. The final session will serve as a graduation ceremony.
Table 2 Outline of Seven WeChat Group Interaction Learning
Session No.
Self-care domain
Title
Core content
Session One
Symptom perception
Hello, my buddy
Heart failure experience
Session Two
Self-care
maintenance
Wisdom on the tip of
tongue
Dietary management of
heart failure
Session Three
Self-care
maintenance
Comrades in the
pillbox
Understanding the
purpose and side effect
of medications and
coping strategies
Session Four
Self-care
maintenance
Energizing the Heart
Safe physical activities
skills
Session Five
Symptom perception
and self-care
management
Symptom
Scouts:
These Symptoms Are
Signals
Recognition early
symptoms and severity
Session Six
Symptom perception
and self-care
management
Being Well-Aware
Strategies to
management symptoms
Session
Seven
All domains
Celebrating Progress:
My Change List
Self-care improvements
Each
session
will
incorporate
four
main
activities:
structured
peer
sharing,
problem-solving collaborative tasks, goal setting or progress sharing, and group
contracts. Each session will begin with a brief educational talk provided by the facilitator

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to set the stage. The structured peer sharing will utilize a theme-guided approach,
encouraging participants to engage in timed sharing and keyword fill-ins. This format
aims to build emotional resonance and help reshape participants' understanding of
health issues. The problem-solving collaborative tasks will integrate group experiences
through interactive formats such as scenario simulations or graphical tools for
co-creation, resulting in scalable solutions. Goal setting and progress sharing will focus
on celebrating achievements and collaboratively addressing obstacles, utilizing group
attention to foster positive social accountability. Finally, group contracts will establish
daily health tasks, transforming external requirements into personal commitments while
providing opportunities for daily interaction. Participants will be encouraged to use
expression cards for real-time interaction.
Moreover, during the first session, participants will collaboratively create a group slogan
and set a group name to form a group identity. The final session will celebrate
participants' progress and reward achievements. The facilitator will also encourage
caregivers or significant others to join the group discussions to further enhance the
support system and increase engagement.
Daily synchronous interaction
Daily synchronous interactions will take place in the WeChat group chat room, initiated
by the facilitator. These interactions will include fixed group relays based on the group
contract, random relays triggered by current events, and weekly quizzes. The aim of
these activities is to repeat rituals of interaction that accumulates emotional energy
among participants.
Each week, five group tasks closely aligned with the group contract will be conducted,
such as weight monitoring check-ins and dietary sharing. The specific content and
format will be decided during the group contract activity in the group discussion. On task
days, the facilitator will reiterate the group slogan and remind members to start the relay
tasks. Given the participants' age and health considerations, low-barrier forms of
interaction, such as sending emojis, liking posts, and brief voice messages, will be
encouraged.
To further enhance engagement, facilitators can introduce random relay tasks centered
around focused topics. For example, approaching holidays, facilitators can inquire about
holiday plans or dining arrangements while reminding participants to consider low-salt
diets. Participants will also be encouraged to express themselves freely by posting
photos and diaries to share daily stories, and other formats.
Additionally, weekly quizzes are designed to foster light competition while promoting the
learning of self-care. Each online quiz will consist of five multiple-choice questions
related to the self-care topics discussed. Participants will earn points by answering

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questions, motivating them to actively engage in learning and discussions. Timely
feedback will be provided, especially for incorrect answers.
Gamification strategies
The points system and leaderboard are designed to spark participants' interest through
friendly competition, fostering a sustained engagement and attention to external social
network. Participation in group online discussions, relay tasks and weekly quizzes will be
awarded points. Points will be counted by the facilitator and updated in the group at a
fixed time every day. By tracking points and leaderboard, participants will be motivated
to actively participate and interact with one another, creating a dynamic environment that
encourages ongoing interaction.
Resource hub
The resource hub aims to provide ongoing support and optimize the accessibility of
information. Participants will access the self-care resource hub via WeChat, which
includes articles, videos, guidelines, peer experiences, and other useful information.
Participants can freely and repeatedly access and view these resources for in-depth
learning and practice. The resource hub will be regularly updated based on participants'
needs to help them manage their health more effectively.
3.3.3 Control group: usual care
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. They can consult with the research
assistants via WeChat for any questions they may have, but the research assistants will
only provide explanations related to the health education manual and will not offer
additional educational resources or group interactions.
3.4 Measures
Both the feasibility study and the larger-scale RCT will collect the same primary and
secondary outcomes, as well as demographic and clinical profiles. Additionally, the
feasibility study will gather extra feasibility indicators, such as recruitment status,
attendance, and retention rates. One-on-one semi-structured interviews will also be
conducted to evaluate the appropriateness, practicality, and acceptability of the
intervention measures.
3.4.1 Primary Outcomes
Social frailty will be assessed by using SFS-8 scale was developed by Pek [42] in
Singapore, comprising the items from Makizako’s social frailty 5-item, Tsutsumimoto’s
5-item, Teo’s social frailty index, and Tanaka’s social frailty assessment. It consists of
eight questions covering whether they visit friends sometimes, seek advice from family

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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). It was
translated by Montayre in 2024 and validated in Hong Kong’s elderly population with
Cronbach's α coefficient of 0.67[43].
3.4.2 Secondary Outcomes
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. Introduced by Yu in 2004, this scale was
validated in Hong Kong heart failure patients and showed a Cronbach's α of 0.98 and a
2-week retest reliability of 0.84 [44]. It was culturally adapted for coronary heart disease
patients by Wang in 2013, demonstrating acceptable internal consistency (Cronbach's α
= 0.91, intraclass coefficient = 0.89) [45].
Social participation serves as an indicator of engagement in social activities. The Impact
on Participation and Autonomy Questionnaire (IPA) [46], which is a self-report instrument
that measures people's perceptions of participation and autonomy, will be used to
evaluate the social participation in older adults with heart failure. The original scale has a
Cronbach's α ranging from 0.81 to 0.91[47]. 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. The scale has been validated
for reliability and validity in stroke patients, with Cronbach's α coefficients for each
dimension ranging from 0.782 to 0.965, and the content validity index (CVI) for individual
items ranging from 0.87 to 1.00 [48]. The Chinese version has also demonstrated good
internal consistency in studies involving other elderly populations[49].
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. This
scale assesses the ability of heart failure patients to manage their care and make
informed decisions. The maintenance dimension measures compliance and symptom
detection, the management dimension evaluates symptom recognition and care
assessment, and the confidence dimension reflects patients' beliefs in their abilities.
Scores range from 0 to 100, with 70 or above indicating adequate self-care. Introduced
in 2010 by Yu, the SCHFI was validated for reliability and validity in the Chinese heart
failure population [50]. The updated version 7.2 showed Cronbach's α coefficients

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between 0.77 and 0.89, with test-retest reliability of 0.75-0.78 [51].
3.4.3 Demographic and clinical profiles
Demographic variables will be collected through self-reporting, including gender, age,
education, monthly income, marital status, and living area. The etiology of heart failure,
time since diagnosis of heart failure, NYHA classification, and the most recent medical
test results such as B-type natriuretic peptide (BNP), pro-BNP, and left ventricular
ejection fraction will be retrieved from the medical record. Furthermore, the number of
hospitalizations in the past year, co-morbidity assessed by the age-adjusted Charlson
Comorbidity Index (a-CCI), and heart failure symptom burden evaluated by the Chinese
version of the Memorial Symptom Assessment Scale for Heart Failure (MSAS-HF) will be
recorded through the self-report.
3.4.4 Feasibility indicators
For the feasibility study, we will comprehensively assess the feasibility through
recruitment status, attendance, and retention rates. First, the recruitment status will be
divided into screening eligibility rates and final recruitment rates to evaluate the ability to
successfully recruit target participants within the designated time and environment.
Specifically, the screening eligibility rate is calculated as the ratio of eligible participants
to the total number of screened individuals, while the recruitment rate is defined as the
ratio of successfully recruited participants to the total number of potential participants
contacted, with both expressed as percentages.
Next, attendance will be measured using two specific indicators: (1) the attendance rate
for online group meetings, which is calculated based on the total number of meetings
attended divided by the expected number of intervention meetings; (2) the number of
weekly group interactions, including text, voice, or image contributions, as well as active
days, which will help indicate effective dosage. Retention rate will be calculated as the
ratio of the number of participants who completed the intervention to the total number of
participants.
We will conduct one-on-one semi-structured interviews to evaluate the appropriateness,
practicality, and acceptability of the intervention measures. The interviews will focus on
three areas: (1) Appropriateness: Assessing whether the intervention meets participants'
needs and expectations; (2) Practicality: Evaluating the feasibility of the intervention in
real-world settings, including participants' experiences; (3) Acceptability: Understanding
participants' overall perceptions, including satisfaction, engagement factors, and
potential barriers. Additionally, we will collect participants' suggestions for improving the
intervention, providing a basis for future optimization. Interview outline is listed in table 3.
Table 3 Semi-structured interview guide for acceptability
Topic
Questions

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3.5 Data analysis
Data analysis will be conducted using SPSS version 25. Descriptive statistics will be
calculated for all variables, including means, standard deviations, frequencies, and
percentages. The baseline characteristics of the two groups of participants will be
compared using t-tests, chi-square tests, Fisher's exact tests or Mann–Whitney U-test,
as appropriate. The significance level for all tests will be set at p < .05.
This study will employ an intention-to-treat (ITT) approach, ensuring that all participants
will be included in the final analysis regardless of whether they complete the study.
Missing data will be addressed using direct maximum likelihood estimation to minimize
bias. The effect sizes for changes in social frailty, perceived social support, social
participation, and self-care will be investigated using means (M) and standard deviations
(SD). A mixed repeated measures ANOVA and post-hoc comparisons will be used to
Appropriateness
Does the content provided by this intervention program meet your
needs? Please be specific.
Do you feel that the goals and content of the intervention meet your
expectations?
Are there any aspects that you feel are particularly appropriate or
inappropriate for your situation? Please be specific.
Practicality
What difficulties have you encountered in your participation? Please
provide examples.
How would you describe the experience of participating in online
group sessions and daily in-group interactions? Are there any parts of
the program that are difficult to implement?
What do you think are the biggest challenges to complete the
intervention program?
How do you think the intervention program could have been made
easier to implement? More easily replicated or accepted by heart
failure patients?
Acceptability
How satisfied are you with the intervention overall? On a scale of
1-10, how many points would you give? Why?
Which parts or activities appealed to you the most? Or which parts
may have caused hesitation or loss of interest?
Would you like to continue to participate? Why?
What
reasons
do
you
anticipate
might
prevent
others
from
participating in the program?
Improvements
If you were asked to suggest 1-2 changes, what would you change or
add?
Are there any other comments that were not mentioned but are
important?

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examine the effects of the intervention group compared to the control group on the
outcomes. To explore which outcome indicators may be most important for the primary
trial, Pearson correlation analysis will be conducted between the change scores of social
frailty, perceived social support, social participation, and self-care, and the weekly
average number of active days and group interactions, and group meeting participation
rate.
In the qualitative data analysis, investigators will independently employ a
phenomenological inductive approach to conduct thematic analysis of the interview data.
They will carefully read the transcriptions to identify recurring important themes and
sub-themes, aiming to gain a deeper understanding of participants' experiences and
perspectives. Following the initial analysis, investigators will discuss and compare their
results to validate the accuracy of the themes and ensure the comprehensiveness of the
analysis.
For the full RCT analysis, A generalized estimating equation (GEE) model will be used to
compare the changes in outcomes between the two groups at time points T0 (baseline),
T1 (post-test), and T2 (3 months post-test), adjusting for potential confounding variables.
Interaction terms for time points and groups will be included in the GEE model to assess
the differences in outcomes between groups from baseline to each post-test endpoint
while controlling for significant baseline confounding variables (p < .25) [52, 53]. When
significant interactions are found, post hoc analyses will be conducted to compare
changes at each time point relative to baseline, providing a deeper understanding of the
intervention effects. The significance level for all tests will be set at p < .05. Results will
be presented as means with 95% confidence intervals (CIs) to clearly illustrate group
differences, ensuring the reliability and validity of the study conclusions.
3.6 Data management
Paper copies of raw data will be stored securely in locked cabinets with keys held by the
Principal Investigator. Electronic versions of the data will be stored on a hard disk. All
data collected will be processed and verified only by the investigators, research
assistants involved in the project, the investigator's designated inspectors, and the ethics
committees. Individuals who leave their current position will forfeit the right to access or
use the data. Measures will be in place to ensure that individual participants cannot be
identified directly from the datasets used for analysis. All collected personal information,
research data, and related documents will be retained for 10 years following the
completion of the study. Upon the expiration of the designated storage period, all data
will be securely destroyed. All digital files containing personal and study data will be
permanently deleted using secure deletion methods to ensure that they cannot be
recovered. A record of the destruction process will be maintained, detailing the date,
method of destruction, and individuals involved, ensuring accountability and compliance
with ethical guidelines.

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4 Timetable
Proposed study start date: 1st September 2025
Proposed study end date: 30st September 2027
Tentative final report submission date to CIRB/CREC/IRB: 31st December 2027
5 Consent
The
procedure
for
obtaining
patient
informed
consent
involves
face-to-face
communication.
Following
a
detailed
discussion
to
ensure
patients
have
a
comprehensive understanding of the study's purpose, risks, and benefits, a printed
version of the informed consent form will be provided to the patients. Emphasis will be
placed on the voluntary nature of participation, with patients informed of their right to
refuse or withdraw from the study at any time without repercussions. Patients will be
given a minimum of 30 minutes to consider their decision and ask questions without
feeling rushed or pressured. Only participants who meet the inclusion criteria and
demonstrate understanding of the informed consent form will be asked to sign it.
6 Major ethics issue
This study will adhere to the ethical principles outlined in the Declaration of Helsinki.
Participation in the study is voluntary. Participants will provide written informed consent
and have the right to discontinue or withdraw from the study at any time without facing
any repercussions. If a participant decides to withdraw, the data will be destroyed and
will not be included in the analysis.
For the quantitative analysis, the dataset will be free of personally identifiable information
to ensure participant anonymity. Furthermore, this dataset will not be made publicly
available for secondary analysis. Any sensitive information that could potentially identify
participants will be omitted from the research report. The results of the research may be
published or presented at conferences, but personal data will not be revealed.
7 Describe any unusual or discomforting procedures to be used:
No.
8 Are there any hazards associated with the investigation?
No.
9 Financing and insurance
There was no financial support from any source for this study. Insurance is not required
for this study.
10 Dissemination of study result
The results will be shared at local and international conferences and published in
peer-reviewed journals. The progress and final reports will be gathered and sent to the
Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong
West Cluster (HKU/HA HKW IRB).

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11 Conflict and interest
No.
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