Gendered Psychosocial Pathways of Social Frailty in Older Adults With Heart Failure: A Longitudinal Study of an AI-Based Conversational Social-Support Intervention.
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All trials for Heart Failure All trials of AI-Based Conversational Social Support All trials of Community Social Participation
-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).
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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| AI Conversational Support Group | Experimental | Behavioral: AI-Based Conversational Social Support | Participants in this group will receive an AI-based conversational social-support intervention delivered via a tablet. |
| Community Social Participation Group | Active comparator | Behavioral: Community Social Participation | 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. |
| Control Group | No intervention | | Participants in this group will maintain their routine activities without receiving the AI-based conversational social-support intervention or the community social participation intervention. |
- AI-Based Conversational Social Support (Behavioral): 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 Participation (Behavioral): Participants will be encouraged to attend regular community social activities to enhance social interaction, with continued care and follow-up by telephone.
+Outcome measures
Primary outcomes
- Change in Social Frailty Score [Baseline and 1, 3, 6, and 12 months after intervention]: 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.
+Eligibility
Sex: All, ages: 60 Years to any
Inclusion Criteria:
1. Participants aged 60 years or older.
2. Diagnosis of chronic heart failure (CHF).
3. Ability to communicate effectively in Mandarin or Taiwanese.
Exclusion Criteria:
1. Unstable heart failure.
2. Severe comorbidities, such as end-stage renal disease, advanced hepatic dysfunction, or terminal malignancies.
3. Severe cognitive deficits that impede the ability to provide informed consent or participate in study interventions.
4. Uncorrected visual or hearing impairments that hinder effective communication or interaction with the AI-based conversational social-support intervention.
5. Active psychiatric conditions, including major depression or psychosis, that could interfere with study participation or adherence.
+Locations (2)
| Facility | City | Country | Status |
|---|
| New Taipei Municipal Tucheng Hospital (Built and Operated by Chang Gung Medical Foundation) | New Taipei City, New Taipei City | Taiwan | Recruiting |
| Chang Gung Memorial Hospital, Linkou | Taoyuan, Taoyuan City | Taiwan | Recruiting |
+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34472374
+Investigators
- Jeng Wang, PhD, Principal investigator, Chang Gung University of Science and Technology, Department of Nursing