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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frailty and Quality of Life in Patients With Heart Failure | Experimental | 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 |
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| Frailty and Quality of Life | No Intervention | Patients in this group maintain their daily life activities, and there is no intervention given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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 |
| 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 . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ai-Fu Chiou, PhD | National Yang Ming Chiao Tung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Yang-Ming University | Taipei | 112 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 JJ, Ferrucci L, Forman DE. (2014). Frailty assessment in the cardiovascular care of older adults. Journal of the American College of Cardiology, 63(8), 747-762. https://doi.org/10.1016/j.jacc.2013.09.070. PMID: 24291279 Denfeld QE, Winters-Stone K, Mudd JO, Gelow JM, Kurdi S, Lee CS. (2017). The prevalence of frailty in heart failure: A systematic review and meta-analysis. The International Journal of Cardiology, 236, 283-289. PMID: 28215466 Flint KM, Pastva AM, Reeves GR. (2019). Cardiac rehabilitation in older adults with heart failure: Fitting a square peg in a round hole. Clinics in Geriatric Medicine, 35(4), 517-526. https://doi.org/10.1016/j.cger.2019.07.008. PMID: 31543182 | ||
| 41482005 | Derived | Wang TC, Hsieh YC, Yang CY, Lee CM, Liu CY, Chiou AF. Effects of a multimodal support intervention (the NICE-Support programme) on frailty and quality of life in patients with heart failure: a randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Apr 29;25(2):329-338. doi: 10.1093/eurjcn/zvaf187. |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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One research assistant is trained for being a outcomes assessor in this study who did not know the allocation of participants.
| 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 |