The Effect of NICE Support Program on Frailty and Quality of Life in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ai-Fu Chiou
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change Frailty Assessment Scale for Heart Failure, FAS-HF) and Clinical Frailty Scale scores
研究概览
简要总结
This RCT study aims to examine effects of a NICE Support Program in heart failure patients.
The following hypotheses were tested: patients who received the NICE program will report significant improvement in frailty , social support, anxiety, and depression, quality of life, and nutritional assessment at baseline,4 weeks, 12 weeks and 24 weeks.
详细描述
This study aims to develop NICE Support program, and examine the effects of an NICE program in heart failure patients. An experimental design is used. Subjects are selected using a purposeful sampling and are randomly assigned to the intervention or control group by using block size randomization method. Patients in the intervention group will receive a 12 week NICE Support program including: individual consultation, nutritional consultation, teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls. Data are collected by physical indicators and a structural questionnaire to measure frailty, quality of life, social support, anxiety and depression, symptom distress at baseline, 4 weeks, 12 weeks and 24 weeks . Data analysis includes descriptive statistics, Pearson correlation coefficient, independent t test, chi square, one way ANOVA 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
One research assistant is trained for being a outcomes assessor in this study who did not know the allocation of participants.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged above 20 and stable condition and had received physical activity.
- •Clear consciousness, can communicate with Chinese and Taiwanese.
- •Consent to join in this study.
- •Have a smartphone and be able to join social media(Line: heart together-go go go )
排除标准
- •Bed-ridden or unable to perform activities of daily living independently.
- •Unstable illness condition.
- •Emergency condition.
- •Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
- •Patients with increased nerve, muscle, bone or rheumatoid diseases due to exercise
结局指标
主要结局
Change Frailty Assessment Scale for Heart Failure, FAS-HF) and Clinical Frailty Scale scores
时间窗: baseline, 4week, 12 week, 24week
Changes from baseline Frailty Assessment Scale for Heart Failure, FAS-HF) scores including three indicators: physical, Psychological and social , at 6 weeks, 12 weeks, 24 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 from baseline Clinical Frailty Scale including nine indicators, the higher scores indicate higher frailty.
Changes in symptoms distress scores
时间窗: baseline, 4week, 12 week, 24week
Changes from baseline symptoms distress scale at 4 weeks, 12 weeks, 24 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.
次要结局
- The Minnesota living with heart failure questionnaire(MLHFQ)(baseline, 4week, 12 week, 24week)
- Changes in anxiety and depression scores(baseline, 4week, 12 week, 24week)
研究者
Ai-Fu Chiou
Professor
National Yang Ming Chiao Tung University