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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Frailty; Self-management
• Intervention / Treatment: Behavioral: FRAIL-SM Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 328
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ai-Fu Chiou, PhD; Phone Number: 88628267354; Email: afchiou@nycu.edu.tw

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Chih Yun Wei, BS
  • Taipei, Taiwan
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Yia-Ling Chang, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients in this group maintain their daily life activities, and there is no intervention given.
Experimental: intervention group; Patients in this group will receive a 8-week family-based frailty self-management program including: (1) one 20-30 minute individual consultation (teaching how to join the family-based frailty self-management program by using poster); (2) provided self-management booklet; (3) provided family-based frailty self-management program video through Line group meeting, once per two weeks ; (4) individual consultation through telephone follow-up once per week for 8 weeks	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Ai-Fu Chiou, PhD, National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Heart failure; self management; Frailty; family-based program
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Frailty
• Other Study ID Numbers: YM111045EF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No