Comparing Sarcopenia , Physical, Psychological and Social Frailty in Hospitalized Older Women Congestive Heart Failure in Metropolitan and Rural Settings

NCT ID: NCT07100366

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-07-31

Brief Summary

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).

Conditions

65 Years Older; CHF - Congestive Heart Failure; Social Communication; Sarcopenia in Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

ChatGPT intervention

ChatGPT intervention

Group Type: EXPERIMENTAL

ChatGPT

Intervention Type: BEHAVIORAL

Phase 3:In Experimental Group 1, participants will be invited to use the ICT app, which they are encouraged to engage with for at least 15 minutes daily. This app is designed to actively monitor the users' emotional status and automatically notify both the research team and family members if any negative mood is detected.

Community social participation group

Group Type: EXPERIMENTAL

community social

Intervention Type: BEHAVIORAL

Phase 3:In Experimental Group 2, participants will be encouraged to increase their social participation through community-based activities, while the Control Group will continue with their routine lifestyle.

Interventions

ChatGPT

Phase 3:In Experimental Group 1, participants will be invited to use the ICT app, which they are encouraged to engage with for at least 15 minutes daily. This app is designed to actively monitor the users' emotional status and automatically notify both the research team and family members if any negative mood is detected.

Intervention Type: BEHAVIORAL

community social

Phase 3:In Experimental Group 2, participants will be encouraged to increase their social participation through community-based activities, while the Control Group will continue with their routine lifestyle.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

202500795B0

Identifier Type: -

Identifier Source: org_study_id