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Completed

NCT Number: NCT05366686

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

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.

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Key information

Conditions

Frailty Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NICE Support Program

Behavioral

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

Primary outcomes

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

    Time frame: 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.

  2. Changes in symptoms distress scores

    Time frame: 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 outcomes

  1. The Minnesota living with heart failure questionnaire(MLHFQ)

    Time frame: 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 .

  2. Changes in anxiety and depression scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ai-Fu Chiou

Other

Registry information

Acronym: NICE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 9, 2022
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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