Development of Family-based Frailty Selfmanagement Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- National Yang Ming Chiao Tung University
- Enrollment
- 232
- Locations
- 2
- Primary Endpoint
- Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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, 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.
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.
Investigators
Eligibility Criteria
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
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 PaO
- •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:
Outcomes
Primary Outcomes
Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores
Time Frame: baseline, 4week, 8week, 12week
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.
Changes in The Minnesota living with heart failure questionnaire(MLHFQ) scores
Time Frame: baseline, 4week, 8week, 12week
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 .
Changes in the Self-Care of Heart Failure Index scores
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
Changes from baseline Self-Care of Heart Failure Index scores including three indicators: self-maintenance, self-management and self confidence , at 4 weeks, 8 weeks, 12 weeks. This scale contains 22 items, each item use Likert scale four point scoring, the total scores ranged from 22 to 88, the higher scores indicate better self-care.
Secondary Outcomes
- Changes in The Caregiver Strain Index(CSI)(baseline, 4week, 8week, 12week)
- Changes in heart failure knowledge of caregivers(baseline, 4week, 8week, 12week)
- Changes in caregivers' quality of life(baseline, 4week, 8week, 12week)
- Changes in caregivers confidence of heart failure self care(baseline, 4week, 8week, 12week)
- Changes in symptoms distress scores(baseline, 4week, 8week, 12week)
- Changes in anxiety and depression scores(baseline, 4week, 8week, 12week)