Development of Family-based Frailty Selfmanagement Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistants are trained for being outcomes assessors in this study who did not know the allocation of participants.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •have serious chronic diseases and need to dependent on others for daily living
- •diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
- •have an employment relationship with the patient
研究组 & 干预措施
Control group
Patients in this group maintain their daily life activities, and there is no intervention given.
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
干预措施: FRAIL-SM Program (Behavioral)
结局指标
主要结局
Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores
时间窗: 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
时间窗: 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
时间窗: 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.
Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores
时间窗: 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
时间窗: 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 .
次要结局
- 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)