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

C

Chang Gung University of Science and Technology

Status

Not yet enrolling

Conditions

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

Treatments

Behavioral: community social
Behavioral: ChatGPT

Study type

Interventional

Funder types

Other

Identifiers

NCT07100366
202500795B0

Details and patient eligibility

About

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).

Enrollment

200 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 3 patient groups

control group
No Intervention group
ChatGPT intervention
Experimental group
Description:
ChatGPT intervention
Treatment:
Behavioral: ChatGPT
Community social participation group
Experimental group
Treatment:
Behavioral: community social

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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