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

Quality of Life Clinical Trial

— NICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366686
• Other study ID #: YM108131E
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: National Yang Ming University
• Contact: Ai-Fu Chiou, PhD
• Phone: 88628267354
• Email: afchiou[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Heart Failure
• Quality of Life

Intervention

Behavioral:
• NICE Support Program
Patients in experimental group will receive a 12 week NICE Support program; patients in control group maintain their usual life activities.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Afilalo, J. (2019). Evaluating and treating frailty in cardiac rehabilitation. Clinics in Geriatric Medicine, 35(4), 445-457. https://doi.org/10.1016/j.cger.2019.07.002. PMID: 31543177 Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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