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

Not Applicable

Completed

• Conditions: Frailty; Quality of Life
• Interventions: Behavioral: NICE Support Program

• Registration Number: NCT05366686
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Primary Completion: 2024-02-08
• Study Completion: 2024-02-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Aged above 20 and stable condition and had received physical activity.
2. Clear consciousness, can communicate with Chinese and Taiwanese.
3. Consent to join in this study.
4. Have a smartphone and be able to join social media(Line: heart together-go go go )

Exclusion Criteria

1. Bed-ridden or unable to perform activities of daily living independently.
2. Unstable illness condition.
3. Emergency condition.
4. Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
5. Patients with increased nerve, muscle, bone or rheumatoid diseases due to exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frailty and Quality of Life in Patients With Heart Failure	NICE Support Program	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

Primary Outcome Measures

Name	Time	Method
Change Frailty Assessment Scale for Heart Failure, FAS-HF) and Clinical Frailty Scale scores	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	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.

Secondary Outcome Measures

Name	Time	Method
The Minnesota living with heart failure questionnaire(MLHFQ)	baseline, 4week, 12 week, 24week	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 .
Changes in anxiety and depression scores	baseline, 4week, 12 week, 24week	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.

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei, Taiwan