Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT07100366
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).
Study:
NCT07100366
Study Brief:
Protocol Section:
NCT07100366