The Effect of NICE Support Program on Frailty and Quality of Life in Patients With Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of NICE Support Program on Frailty and Quality of Life in Patients With Heart Failure

Conditions
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Frailty, Quality of Life

Intervention / Treatment
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* Behavioral: NICE Support Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in the intervention group will receive a 12 week exercise program including: individual consultation, nutrition consultation, teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frailty and Quality of Life in Patients With Heart Failure<br>Patients in this group will receive a 12 week exercise program including: (1) one 40-60 minute individual consultation (teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls); (2) provided exercise booklet, exercise log, exercise video; (3) Nutritional consultation; (4) telephone follow-up once per week for 12 weeks | Behavioral: NICE Support Program<br>* Patients in experimental group will receive a 12 week NICE Support program; patients in control group maintain their usual life activities.<br>|
| No Intervention: Frailty and Quality of Life<br>Patients in this group maintain their daily life activities, and there is no intervention given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Frailty Assessment Scale for Heart Failure, FAS-HF) and Clinical Frailty Scale scores | 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. | baseline, 4week, 12 week, 24week | 
| Changes in symptoms distress scores | 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. | baseline, 4week, 12 week, 24week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Minnesota living with heart failure questionnaire(MLHFQ) | Changes from baseline Minnesota living with heart failure questionnaire at 4 weeks, 12 weeks, 24 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, 12 week, 24week | 
| Changes in anxiety and depression scores | Changes from baseline hospital anxiety and depression scale at 6 weeks, 12 weeks, 24 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, 12 week, 24week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Quality of Life, Heart failure, Exercise program, nutrition