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

Quality of Life Clinical Trial

— FRAIL-SM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765721
• Other study ID #: YM111045EF
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: National Yang Ming University
• Contact: Ai-Fu Chiou, PhD
• Phone: 88628267354
• Email: afchiou[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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, self-care ability and quality of life in patients with heart failure and their family's strain 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.

Description:

This 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, self-care ability and quality of life in patients with heart failure and their family's strain and quality of life. Patients are recruited with a convenience sampling from two medical centers in Taiwan.

A cross-sectional study is adopted to examine the associated factors of frailty and self-management in patients with heart failure. Besides, a qualitative research with face-to-face individual interview is conducted to understand the experience of frailty and self-management in patients with heart failure and their families. Then, a randomized controlled trial is conducted. Subjects are selected using a convenience sampling and are randomly assigned to the intervention or control group. Patients in the intervention group will receive an 8-week family-based frailty self-management program. 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 such as levels of B-type natriuretic peptide, hemoglobin, hematocrit, albumin at baseline, 4 weeks, 8 weeks and 12 weeks after enrollment. Data analysis includes descriptive statistics, Pearson correlation coefficient, independent t-test, chi-square, one-way ANOVA, multiple regression, structural equation modeling, and generalized estimating equation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Heart Failure
• Quality of Life
• Self-management

Intervention

Behavioral:
• FRAIL-SM Program
Patients in experimental group will receive a 8 week family-based frailty self-management program; patients in control group maintain their usual life activities.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores	Changes from baseline Frailty Assessment Scale for Heart Failure (FAS-HF) scores including three indicators: physical, Psychological and social , at 4 weeks, 8 weeks, 12 weeks. FAS-HF scale contains 15 items, each item use Likert scale five point scoring, the total scores ranged from 0 to 45,the higher scores indicate higher frailty.	baseline, 4week, 8week, 12week
Primary	Changes in The Minnesota living with heart failure questionnaire(MLHFQ) scores	Changes from baseline Minnesota living with heart failure questionnaire at 4 weeks, 8 weeks, 12 weeks. The Minnesota living with heart failure questionnaire contains 21 questions regarding the effects of heart failure on patients' physical (eight questions),emotional (five questions) and general (eight questions) dimensions. The possible answer for each question ranges from 0(no) to 5(a lot), and the total score range is 0-105; a higher score indicates lower quality of life .	baseline, 4week, 8week, 12week
Secondary	Changes in symptoms distress scores	Changes from baseline symptoms distress scores at 4 weeks, 8 weeks, 12 weeks. Symptoms distress scale contains 17 common symptoms items, each item use Likert scale five point scoring, the total scores ranged from 17 to 85, the higher scores indicate worse symptom distress	baseline, 4week, 8week, 12week
Secondary	Changes in anxiety and depression scores	Changes from baseline hospital anxiety and depression scale at 4 weeks, 8 weeks, 12 weeks. The hospital anxiety and depression scale contains 14 questions(7 for assess anxiety and 7 for assess depression), each item use Likert scale four point scoring, the total scores ranged from 0 to 21, the higher scores indicate more severe anxiety and depression level.	baseline, 4week, 8week, 12week
Secondary	Changes in caregivers confidence of heart failure self care	Changes in the Self-Care of Heart Failure Index (SCHFI) scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The SCHFI is a self-report measure comprised of 15 items rated on a 4-point response scale and divided into 3 subscales: self-care maintenance, self-care management, and self-care confidence. Self-care maintenance consists of 5 items assessing adherance to HF self care recommendations. Self-care management consists of 6 items assessing the ability to recognize and deal with HF symptoms. Self-care confidence consists of 4 items assessing the confidence in control and manage HF symptoms.	baseline, 4week, 8week, 12week
Secondary	Changes in The Caregiver Strain Index(CSI)	Changes in the Caregiver Strain Index(CSI) scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The CSI is a 13-item objective questionaire designed to assess level of stress experienced by the informal caregivers.	baseline, 4week, 8week, 12week
Secondary	Changes in heart failure knowledge of caregivers	Changes in Dutch Heart Failure Knowledge Scale (DHFKS) scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The DHFKS consists of 15 items assessing HF knowledge: 4 items regarding general HF information, 6 items regarding HF treatment (diet, fluid restrictions and activity) and 5 items assessing symptoms and symptom recognition.	baseline, 4week, 8week, 12week
Secondary	Changes in caregivers' quality of life	Changes in the WHO Quality of Life-Brief(WHOQOL-BREF) Taiwan version scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The WHOQOL-BREF Taiwan version is a 28-item questionaire rated on a 5-point response scale. It divides quality of life into 4 domains: physical health, psychological, social relationships and environment.	baseline, 4week, 8week, 12week