Gendered Psychosocial Pathways of Social Frailty in Older Adults With Heart Failure: A Longitudinal Study of an AI-Based Conversational Social-Support Intervention.
Sponsor study identifier
interventional
174
1 country
2
Study Start
November 5, 2025
Actual (reported)Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2025
Actual (reported)October 1, 2026
Actual (reported)October 7, 2026
Actual (reported)July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline and 1, 3, 6, and 12 months after intervention
Participants in this group will receive an AI-based conversational social-support intervention delivered via a tablet.
Participants 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.
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.
Participants will be encouraged to attend regular community social activities to enhance social interaction, with continued care and follow-up by telephone.
New Taipei Municipal Tucheng Hospital (Built and Operated by Chang Gung Medical Foundation)
New Taipei City, New Taipei City, 236, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taoyuan City, 333, Taiwan
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.
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.
Jeng Wang, PhD
Chang Gung University of Science and Technology, Department of Nursing
First Submitted
October 1, 2026
First Posted
October 7, 2026
Study Start
November 5, 2025
Actual (reported)The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
Participants in this group will maintain their routine activities without receiving the AI-based conversational social-support intervention or the community social participation intervention.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10
Individual participant data will not be shared with researchers outside the study team due to participant privacy and confidentiality considerations.
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Source: ClinicalTrials.gov.
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