Family-based program to help heart failure patients manage frailty

Development of Family-based Frailty Selfmanagement Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure

This study is testing a family-based program to help heart failure patients manage frailty and improve their quality of life by involving their loved ones in their care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 328 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: National Yang Ming Chiao Tung University (Academic / other)
• Locations: 2 sites (Taichung and 1 other locations)
• Trial ID: NCT05765721 on ClinicalTrials.gov

What this trial studies

This clinical trial develops a frailty self-management model specifically for patients with heart failure, focusing on a family-based program called FRAIL-SM. The program emphasizes family involvement, self-regulation, autonomy support, information sharing, and linkage to improve frailty, self-care abilities, and quality of life. Participants will be randomly assigned to either the intervention or control group, with data collected at multiple time points to assess various health indicators and quality of life metrics. The study also includes qualitative interviews to gain insights into the experiences of patients and their families regarding frailty and self-management.

Who should consider this trial

Good fit: Ideal candidates are heart failure patients aged 40 and older who are in stable condition and can communicate in Chinese or Taiwanese.

Not a fit: Patients who are bed-ridden, have cognitive dysfunction, or are in the acute stage of heart failure may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly enhance the quality of life and self-management capabilities of heart failure patients and reduce family strain.

How similar studies have performed: Other studies have shown promise in family-based interventions for chronic conditions, suggesting potential success for this approach.

Eligibility criteria

Patients Inclusion Criteria:

1. aged ≥ 40 years.
2. diagnosed by doctros with heart failure and in stable condition.
3. clear consciousness, can communicate with Chinese and Taiwanese.
4. consent to join in this study.
5. have a smartphone or computer and be able to join social media
6. have SOF score ≥ 1

Patients Exclusion Criteria:

1. were bed-ridden or unable to perform activities of daily living independently.
2. diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
3. in the acute stage of the disease, such as inflammation, infection, or vascular embolism
4. with contraindications to exercise, such as those with uncontrolled arrhythmia, unstable heart rate, BP or PaO2.
5. suffer from neurological, muscular, skeletal or rheumatoid diseases that are aggravated by exercise.

Caregivers Inclusion Criteria:

1. aged ≥ 20 years.
2. clear consciousness, can communicate with Chinese and Taiwanese.
3. consent to join in this study with patients.

Caregivers Exclusion Criteria:

1. have serious chronic diseases and need to dependent on others for daily living
2. diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
3. have an employment relationship with the patient

Where this trial is running

Taichung and 1 other locations

• Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
• Tri-Service General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Ai-Fu Chiou, PhD — National Yang Ming Chiao Tung University
• Study coordinator: Ai-Fu Chiou, PhD

Conditions Frailty; Quality of Life; Self-management; self management; Heart failure; family-based program