Clinical Research Directory

HEARTS in Sync + CardioWatch 287-2

The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync. The question guiding this study is: Do patient clinical outcomes differ between those who use the CardioWatch 287-2 during the HEARTS in Sync program as compared to those who participate without using the CardioWatch 287-2? The comparison will happen between two non-randomized groups of patients who are enrolled in the HEARTS in Sync virtual CR program. The wearable device (CardioWatch 287-2), worn on patient's wrists, will provide clinicians with physiological information to better mirror the clinical oversight provided to an in-person CR program. Participants who choose to use the device will be asked to wear it daily. The clinical team will review weekly summary reports to help guide participant progress through the 13-week program. The primary objectives of this study are to: 1. Characterize participants (e.g., demographic health history, patient feedback) between those who choose to use the CardioWatch 287-2 device and those who do not. 2. Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by: 1. Tracking patient enrollment, attendance in virtual education sessions, and program completion rates, 2. Evaluating change in patient bloodwork outcomes, 3. Measuring change is physical ability, 4. Analyzing changes in eating behaviours, and 5. Examining quality of life using validated tools. 3. Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by: 1. Assessing device adherence 2. Reviewing patient feedback survey, and 3. Determining if clinician team were able to access and interpret data collected throughout the program The secondary objective of this study is to compare clinical outcomes of device users during the HEARTS in Sync program with patients who completed the on-site CR program. This research aims to better understand how a medical-grade device may improve virtual CR programming to extend clinical care to the community. As a result, this could lead to a more personalized care and better results for patients.

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

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).

ChatGPT -Based Intervention for Social Frailty in Older Women With CHF : Gender Differences

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.