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Heart FailureNCT07862933

AI-Based Conversational Social Support for Older Adults With Heart Failure

A study testing AI-Based Conversational Social Support and Community Social Participation in people with Heart Failure, run by Chang Gung University of Science and Technology at 2 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This three-year study aims to investigate gender differences in social frailty and evaluate the effects of an artificial intelligence (AI)-based conversational social-support intervention among older adults with chronic heart failure (CHF). 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?
AI-Based Conversational Social Support and Community Social Participation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
2 sitesTaiwan
Study dates
5 Nov 2025to 31 Jul 2028
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

  • Participants aged 60 years or older.
  • Diagnosis of chronic heart failure (CHF).
  • Ability to communicate effectively in Mandarin or Taiwanese.

Who cannot join

  • Unstable heart failure.
  • Severe comorbidities, such as end-stage renal disease, advanced hepatic dysfunction, or terminal malignancies.
  • Severe cognitive deficits that impede the ability to provide informed consent or participate in study interventions.
  • Uncorrected visual or hearing impairments that hinder effective communication or interaction with the AI-based conversational social-support intervention.
  • Active psychiatric conditions, including major depression or psychosis, that could interfere with study participation or adherence.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan2 sites, 2 recruiting
  • New Taipei Municipal Tucheng Hospital (Built and Operated by Chang Gung Medical Foundation)

    New Taipei City, New Taipei City, 236

    Ko-Hsuan Hu, MS, +886 03-2118999#3211, khhu@mail.cgust.edu.tw

    Recruiting
  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Taoyuan City, 333

    Ko-Hsuan Hu, MS, +886 03-2118999#3211, khhu@mail.cgust.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Gendered Psychosocial Pathways of Social Frailty in Older Adults With Heart Failure: A Longitudinal Study of an AI-Based Conversational Social-Support Intervention.

This three-year study aims to investigate gender differences in social frailty and evaluate the effects of an artificial intelligence (AI)-based conversational social-support intervention among older adults with chronic heart failure (CHF).

The study plans to enroll 300-500 adults aged 60 years or older from four Chang Gung Memorial Hospital branches in Taiwan.

Read more

In the first phase, researchers will assess participants' clinical characteristics, sarcopenia, physical activity, and physical, psychological, and social frailty. The study will examine gender differences and identify factors associated with social frailty.

In the second phase, 174 participants are planned to be assigned to three groups: an AI-based conversational social-support group, a community social participation group, and a control group. The AI group will engage in daily 15-30-minute app-based conversations, while the community group will be encouraged to participate in regular social activities. The control group will maintain routine activities.

The third phase will assess longer-term changes in social frailty, emotional well-being, physical activity, and health outcomes, with follow-up assessments at 1, 3, 6, and 12 months after the intervention.

Read the detailed description

This study combines an initial cross-sectional assessment with an embedded intervention trial and longitudinal follow-up.

Phase 1: Baseline assessment

Clinical information and standardized assessments will be collected to examine gender differences in sarcopenia, physical activity, and multidimensional frailty among older adults with chronic heart failure. Structural equation modeling will be used to investigate factors and pathways associated with social frailty.

Phase 2: Intervention

The protocol plans to enroll 174 participants in three groups of 58:

  1. AI-Based Conversational Social-Support Intervention: Participants will be instructed to use an AI-based conversational application for 15-30 minutes daily. The intervention includes conversational support and emotional monitoring. Training, language support, and tablets or internet connectivity will be provided when needed.
  2. Community Social Participation: Participants will be encouraged to attend regular social activities to enhance social interaction, with continued care and telephone follow-up.
  3. Control: Participants will maintain their routine activities.

Clinical and questionnaire-based assessments will be conducted before and after the intervention to evaluate changes in emotional state, physical activity, social frailty, and other health outcomes.

Phase 3: Longitudinal follow-up

Follow-up assessments are planned at 1, 3, 6, and 12 months after the intervention to examine the sustainability of intervention effects and potential gender differences. Assessments include standardized questionnaires and relevant clinical measures.

Conditions
Heart Failure
Being tested
AI-Based Conversational Social Support, Community Social Participation
Keywords
Chronic Heart Failure, Gender Differences, Artificial Intelligence, Conversational Social Support, Frailty, Physical Activity, Older Adults, Longitudinal Study
Medical subject headings
Heart Failure, Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-Based Conversational Social SupportBehavioural

    Participants will receive an AI-based conversational social-support intervention delivered via a tablet. The intervention is designed to provide social interaction and support for older adults with heart failure.

  • Community Social ParticipationBehavioural

    Participants will be encouraged to attend regular community social activities to enhance social interaction, with continued care and follow-up by telephone.

Study groups in NCT07862933
Study groupRoleWhat they receive
AI Conversational Support GroupExperimentalParticipants in this group will receive an AI-based conversational social-support intervention delivered via a tablet.
Receives: Behavioral: AI-Based Conversational Social Support
Community Social Participation GroupActive comparatorParticipants in this group will be encouraged to attend regular community social activities to enhance social interaction. Care and follow-up will also be provided by telephone.
Receives: Behavioral: Community Social Participation
Control GroupNo interventionParticipants in this group will maintain their routine activities without receiving the AI-based conversational social-support intervention or the community social participation intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Social Frailty Score

    Change in social frailty will be assessed using the five-item Makizako Social Frailty Index. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 5. Higher scores indicate greater social frailty and therefore worse outcomes. Changes in scores will be compared among the AI-based conversational social-support intervention group, community social participation group, and control group.

    Measured: Baseline and 1, 3, 6, and 12 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start5 Nov 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
This study uses a three-arm parallel design to evaluate an AI-based conversational social-support intervention among older adults with heart failure. A total of 174 participants are planned for the intervention phase, with 58 participants in each group. Participants will be followed to assess changes in social frailty and related outcomes.
Masking
None (open label)
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07862933
Sponsor's protocol ID
202500678B0C1001
Status last verified
Oct 2026
First submitted
1 Oct 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with researchers outside the study team due to participant privacy and confidentiality considerations.

Publications

  • Son YJ, Shim DK, Seo EK, Won MH. Gender differences in the impact of frailty on 90-day hospital readmission in heart failure patients: a retrospective cohort study. Eur J Cardiovasc Nurs. 2021 Jun 29;20(5):485-492. doi: 10.1093/eurjcn/zvaa028. Epub 2021 Jan 6.

    PubMed 34038526
  • Fear K, Gleber C. Shaping the Future of Older Adult Care: ChatGPT, Advanced AI, and the Transformation of Clinical Practice. JMIR Aging. 2023 Sep 13;6:e51776. doi: 10.2196/51776.

    PubMed 37703085
  • Kastner M, Herrington I, Makarski J, Amog K, Bain T, Evangelista V, Hayden L, Gruber A, Sutherland J, Sirkin A, Perrier L, Graham ID, Greiver M, Honsberger J, Hynes M, Macfarlane C, Prasaud L, Sklar B, Twohig M, Liu B, Munce S, Marr S, O'Neill B, Papaioannou A, Seaton B, Straus SE, Dainty K, Holroyd-Leduc J. Interventions that have potential to help older adults living with social frailty: a systematic scoping review. BMC Geriatr. 2024 Jun 15;24(1):521. doi: 10.1186/s12877-024-05096-w.

    PubMed 38879489
  • Ijaz N, Buta B, Xue QL, Mohess DT, Bushan A, Tran H, Batchelor W, deFilippi CR, Walston JD, Bandeen-Roche K, Forman DE, Resar JR, O'Connor CM, Gerstenblith G, Damluji AA. Interventions for Frailty Among Older Adults With Cardiovascular Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Feb 8;79(5):482-503. doi: 10.1016/j.jacc.2021.11.029.

    PubMed 35115105
  • Talha KM, Pandey A, Fudim M, Butler J, Anker SD, Khan MS. Frailty and heart failure: State-of-the-art review. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):1959-1972. doi: 10.1002/jcsm.13306. Epub 2023 Aug 16.

    PubMed 37586848
  • Watanabe A, Katano S, Yano T, Nagaoka R, Numazawa R, Honma S, Yamano K, Fujisawa Y, Ohori K, Kouzu H, Ishigo T, Katayose M, Hashimoto A, Furuhashi M. Loss of perceived social role, an index of social frailty, is an independent predictor of future adverse events in hospitalized patients with heart failure. Front Cardiovasc Med. 2022 Dec 20;9:1051570. doi: 10.3389/fcvm.2022.1051570. eCollection 2022.

    PubMed 36606289
  • Uchmanowicz I, Pasieczna AH, Wojta-Kempa M, Gobbens RJJ, Mlynarska A, Faulkner KM, Czapla M, Szczepanowski R. Physical, Psychological and Social Frailty Are Predictive of Heart Failure: A Cross-Sectional Study. J Clin Med. 2022 Jan 23;11(3):565. doi: 10.3390/jcm11030565.

    PubMed 35160017
  • Goto T, Kishimoto T, Fujiwara S, Shirayama Y, Ichikawa T. Social frailty as a predictor of all-cause mortality and functional disability: a systematic review and meta-analysis. Sci Rep. 2024 Feb 10;14(1):3410. doi: 10.1038/s41598-024-53984-3.

    PubMed 38341512
  • Makizako H, Tsutsumimoto K, Shimada H, Arai H. Social Frailty Among Community-Dwelling Older Adults: Recommended Assessments and Implications. Ann Geriatr Med Res. 2018 Mar;22(1):3-8. doi: 10.4235/agmr.2018.22.1.3. Epub 2018 Mar 31.

    PubMed 32743237
  • Maeda D, Matsue Y, Kagiyama N, Jujo K, Saito K, Kamiya K, Saito H, Ogasahara Y, Maekawa E, Konishi M, Kitai T, Iwata K, Wada H, Hiki M, Dotare T, Sunayama T, Kasai T, Nagamatsu H, Ozawa T, Izawa K, Yamamoto S, Aizawa N, Wakaume K, Oka K, Momomura SI, Minamino T. Sex differences in the prevalence and prognostic impact of physical frailty and sarcopenia among older patients with heart failure. Nutr Metab Cardiovasc Dis. 2022 Feb;32(2):365-372. doi: 10.1016/j.numecd.2021.10.012. Epub 2021 Oct 23.

    PubMed 34893406
  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

    PubMed 32033882
  • Archer SH, Lee CS, Gupta N, Roberts Davis M, Hiatt SO, Purnell JQ, Tibbitts D, Winters-Stone K, Denfeld QE. Sex differences in the impact of physical frailty on outcomes in heart failure. Heart Lung. 2023 Sep-Oct;61:66-71. doi: 10.1016/j.hrtlng.2023.04.014. Epub 2023 May 6.

    PubMed 37156061
  • Davis MR, Lee CS, Corcoran A, Gupta N, Uchmanowicz I, Denfeld QE. Gender differences in the prevalence of frailty in heart failure: A systematic review and meta-analysis. Int J Cardiol. 2021 Jun 15;333:133-140. doi: 10.1016/j.ijcard.2021.02.062. Epub 2021 Feb 28.

    PubMed 33657397
  • Keshvani N, Pandey A. Beyond Physical Impairment: The Role of Social Frailty in Heart Failure. J Am Heart Assoc. 2021 Sep 7;10(17):e022187. doi: 10.1161/JAHA.121.022187. Epub 2021 Sep 2. No abstract available.

    PubMed 34472383
  • Jujo K, Kagiyama N, Saito K, Kamiya K, Saito H, Ogasahara Y, Maekawa E, Konishi M, Kitai T, Iwata K, Wada H, Kasai T, Nagamatsu H, Ozawa T, Izawa K, Yamamoto S, Aizawa N, Yonezawa R, Oka K, Makizako H, Momomura SI, Matsue Y. Impact of Social Frailty in Hospitalized Elderly Patients With Heart Failure: A FRAGILE-HF Registry Subanalysis. J Am Heart Assoc. 2021 Sep 7;10(17):e019954. doi: 10.1161/JAHA.120.019954. Epub 2021 Sep 2.

    PubMed 34472374

Questions about this trial

What is this clinical trial studying?

A study testing AI-Based Conversational Social Support and Community Social Participation in people with Heart Failure, run by Chang Gung University of Science and Technology at 2 sites in Taiwan.

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 3 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 16 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 2 sites in Taiwan. 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 Jeng Wang, PhD (+886 03-2118999#3435, jengwang@mail.cgust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Social Frailty Score (time frame: Baseline and 1, 3, 6, and 12 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07862933, which also lists 15 linked publications.

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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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