NCT07091435Not yet recruiting
ChatGPT -Based Intervention for Social Frailty in Older Women With CHF : Gender Differences
ChatGPT -Based Intervention for Social Frailty in Older Women With CHF : Gender Differences, Predictive Modeling, and Longitudinal Evaluation
Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study is planned to be completed over three years and will focus on 500 hospitalized older adults with a diagnosis of CHF. The Biopsychosocial model will be used to conduct this study. Phase 1: This phase aims to determine the incidence rates of sarcopenia, frailty/social frailty among hospitalized older adults, and to compare these outcomes in gender differences. Sarcopenia will be identified according to the AWGS guidelines, while clinical characteristics, including ejection fraction, stage of CHF, and comorbidities, will be collected via chart review using the 2024 Guidelines of the Taiwan Society of Cardiology(Y. H. Li et al., 2024). Frailty and social frailty will be measured using the CFS, Tilburg Frailty Indicator (TFI), and Makizako's Social Frailty Questionnaire, respectively, and physical activity levels will be assessed with the International Physical Activity Questionnaire - Short Form (IPAQ-S). To develop a predictive model examining risk factors for social frailty and health outcomes, with a focus on gender differences, we will employ Structural Equation Modeling (SEM). SEM allows for the analysis of complex relationships among variables, facilitating a comprehensive understanding of how these factors interact differently across genders. Phase 2: A quasi-experimental design will be implemented, involving 174 hospitalized older adults with low social frailty scores. Participants will be randomly assigned to one of three groups. Group 1 will use the ChatGPT app for 15-30 minutes daily, with the app actively monitoring their emotional status and automatically notifying the research team and family members if signs of negative mood are detected. Group 2 will be encouraged to increase their social participation through community-based activities. The Control Group will continue their routine lifestyle without additional interventions. Before the intervention, one-on-one training will be provided to Group 1 participants on how to use ChatGPT. Key outcome measures, including mood status (loneliness, anxiety, and depression), physical activity (assessed via IPAQ-S), overall frailty (CFS \& TFI), social frailty scores, and other health indicators, will be assessed at baseline and immediately post-intervention. Phase 3: The aim of this phase is to monitor and compare the longitudinal health outcomes of interventions among the three groups. Key health outcomes will be assessed and compared every three months over a one-year period.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Chang Gung University of Science and Technology
- Diseases
- Heart failure
- NCT number
- NCT07091435
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Sept 2025 to the primary completion date, 31 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients diagnosed with unstable heart failure
- Severe Comorbidities, conditions such as end-stage renal disease, advanced hepatic dysfunction, or terminal malignancies.
- Active psychiatric conditions, including major depression or psychosis, that could interfere with study participation or adherence.
Other
- Severe cognitive deficits that impede the ability to provide informed consent or participate in study interventions.
- Uncorrected visual or hearing impairments that would hinder effective communication or interaction with the ChatGPT application.
Who the study is looking for
- Participants must be 65 years or older.
- Diagnosis of CHF with a left ventricular ejection fraction (EF) of less than 40%
- Ability to communicate effectively in Mandarin or Taiwanese.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.