Comparing Sarcopenia, Physical, Psychological and Social Frailty in Hospitalized Older Women Congestive Heart Failure (CHF) in Metropolitan and Rural Settings: a 3-Year Longitudinal Study Incorporating Information and Communication Technology (ICT) Interventions.
| Registry | NCT07100366 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, health services research |
| Enrollment | 200 (Estimated) |
| Sponsor | Chang Gung University of Science and Technology (Other) |
| Conditions | 65 Years Older, CHF - Congestive Heart Failure, Social Communication, Sarcopenia in Elderly |
| Interventions | ChatGPT, community social (Behavioral) |
| Dates | start 2025-09-01 (estimated), primary completion 2028-07-31 (estimated), completion 2028-07-31 (estimated), first posted 2025-08-03, last updated 2025-08-15 |
Related Papers Related Patents Related Grants Related Experts
All trials for 65 Years Older All trials for CHF - Congestive Heart Failure All trials of ChatGPT All trials of community social
Frailty-encompassing sarcopenia, physical, psychological, and social frailty-is common among older adults with congestive heart failure (CHF) and contributes to adverse outcomes such as rehospitalization, mortality, and poor quality of life. However, few studies have compared these conditions in congestive heart failure (CHF) patients, particularly in elderly women in Taiwan, and effective, tailored Information and Communication Technology (ICT) interventions are scarce.
This three-year study aims to (1) compare baseline characteristics and incidence rates of sarcopenia, physical, psychological, and social frailty among hospitalized older women with congestive heart failure (CHF) in metropolitan versus rural hospitals; (2) evaluate risk factors associated with physical, psychological, and social frailty; (3) monitor health outcomes (rehospitalization, mortality, quality of life) during a one-year follow-up; and (4) assess the effectiveness of an Information and Communication Technology (ICT) intervention designed to enhance social connectivity and emotional well-being.
In Phase 1, clinical data-including ejection fraction, congestive heart failure (CHF) stage, and comorbidity -will be collected using the 2024 Guidelines of the Taiwan Society of Cardiology, while sarcopenia will be identified via Asian Working Group for Sarcopenia (AWGS) guidelines. Physical, psychological, and social frail will be measured with the Tilburg Frailty Indicator (TFI) and Makizako's Social Frailty Questionnaire, respectively, and physical activity will be assessed using the IPAQ-S.
Phase 2 will involve quarterly follow-ups over one year to compare health outcomes between metropolitan and rural settings, and to develop a predictive model of these outcomes. Phase 3 employs a quasi-experimental design with 90 participants randomized into three groups: an Information and Communication Technology (ICT) intervention group (using a dedicated app for at least 15 minutes daily, which monitors emotional status), a community-based social participation group, and a control group maintaining routine care. Key outcomes (mood, physical activity, frailty measures, and clinical status) will be assessed at baseline, immediately post-intervention, and three months thereafter.
This study is expected to identify significant differences between settings and demonstrate that a tailored Information and Communication Technology (ICT) intervention can improve social connectivity and clinical outcomes in older women with congestive heart failure (CHF).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| control group | No intervention | ||
| ChatGPT intervention | Experimental | Behavioral: ChatGPT | ChatGPT intervention |
| Community social participation group | Experimental | Behavioral: community social |
Sex: All, ages: 65 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * Patients diagnosed with unstable heart failure * Severe Comorbidities, conditions 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 would hinder effective communication or interaction with the ChatGPT application. * Active psychiatric conditions, including major depression or psychosis, that could interfere with study participation or adherence.