Clinical trial NCT05765721: Family-based Frailty Self Management Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure
Official title: Development of Family-based Frailty Selfmanagement Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Quality of Life
Self-management
Keywords: Frailty
Quality of Life
self management
Heart failure
family-based program
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 328
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the intervention group will receive an 8-week family-based frailty self-management program including:individual consultation, teaching how to do self-management by family-based frailty self-management video.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores
timeFrame: baseline, 4week, 8week, 12week
measure: Changes in The Minnesota living with heart failure questionnaire(MLHFQ) scores
timeFrame: baseline, 4week, 8week, 12week
Secondary outcomes:
measure: Changes in symptoms distress scores
timeFrame: baseline, 4week, 8week, 12week
measure: Changes in anxiety and depression scores
timeFrame: baseline, 4week, 8week, 12week
measure: Changes in caregivers confidence of heart failure self care
timeFrame: baseline, 4week, 8week, 12week
measure: Changes in The Caregiver Strain Index(CSI)
timeFrame: baseline, 4week, 8week, 12week
measure: Changes in heart failure knowledge of caregivers
timeFrame: baseline, 4week, 8week, 12week
measure: Changes in caregivers' quality of life
timeFrame: baseline, 4week, 8week, 12week
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ai-Fu Chiou, PhD
role: PRINCIPAL_INVESTIGATOR
References: