NCT05765721Completed
Family-based Frailty Self Management Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure
Development of Family-based Frailty Selfmanagement Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 10 Jul 2025
Brief summary (registry, in English)
This randomized controlled trial study aims to develop a frailty self-management model for heart failure patients, and to examine the effect of family-based frailty self-management program (FRAIL-SM) including Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage on frailty, knowledge, self-care ability and quality of life in patients with heart failure and their family's strain, knowledge, confedence, and quality of life. Data is collected by a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, anxiety and depression, social support, and quality of life and physical indicators at baseline, 4 weeks, 8 weeks and 12 weeks after enrollment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 232 (actual)
- First submitted
- 1 Mar 2023
- Start date
- 16 Nov 2023
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- National Yang Ming Chiao Tung University
- Diseases
- Heart failure
- NCT number
- NCT05765721
What you commit to
- Study type: Interventional
- Participants enrolled: 232
- From 16 Nov 2023 to the primary completion date, 1 Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patients Inclusion Criteria:
- aged ≥ 40 years.
- diagnosed by doctros with heart failure and in stable condition.
- clear consciousness, can communicate with Chinese and Taiwanese.
- consent to join in this study.
- have a smartphone or computer and be able to join social media
- have SOF score ≥ 1
- Patients Exclusion Criteria:
- were bed-ridden or unable to perform activities of daily living independently.
- diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
- in the acute stage of the disease, such as inflammation, infection, or vascular embolism
- with contraindications to exercise, such as those with uncontrolled arrhythmia, unstable heart rate, BP or PaO2.
- suffer from neurological, muscular, skeletal or rheumatoid diseases that are aggravated by exercise.
- Caregivers Inclusion Criteria:
- aged ≥ 20 years.
- clear consciousness, can communicate with Chinese and Taiwanese.
- consent to join in this study with patients.
- Caregivers Exclusion Criteria:
- have serious chronic diseases and need to dependent on others for daily living
- diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
- have an employment relationship with the patient
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.