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临床试验/NCT06074887
NCT06074887已完成不适用

The Effect of a Nurse-led, Transtheoretical Model-based Home Education and Follow-up Programme on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial

Cukurova University2 个研究点 分布在 2 个国家目标入组 63 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
European Heart Failure Self-Care Behavior Scale

研究概览

简要总结

The main reason why heart failure (HF) is an important public health problem is that the incidence of HF is increasing and mortality rates remain unchanged despite the decline in the incidence of coronary artery disease. The ageing population and improved medical care services are the main factors supporting this increase. In the guidelines, education and rehabilitation are recommended for symptomatic HF patients with the highest level of evidence and recommendation (Class 1A) and considered as an integral part of HF treatment. The aim of this study was to investigate the effect of Transtheoretical Model-based cardiac rehabilitation training on self-care, quality of life and self-efficacy levels of HF patients. The study was conducted with a parallel-group, randomised controlled experimental design with pre-test and post-test measurements. Thirty-two experimental and 31 control patients, randomly assigned according to inclusion and exclusion criteria, were followed up at home for 12 weeks. Transtheoretical Model (TTM)-based CR training was applied to the intervention group through home visits. Data were collected through socio-demographic information form, behaviour change stage diagnostic form, Minnesota Living with Heart Failure Scale, European Heart Failure Self-Care Behaviour Scale, General Self-Efficacy Scale, home visit follow-up chart, patient follow-up form, telephone counselling follow-up chart and general condition assessment form. Number, percentage, mean and standard deviation were used for descriptive statistics; independent and dependent sample t-test, repeated measures ANOVA test, Chi-Square test, Fisher's Exact test, Fisher-Freeman-Halton Exact test, Wilcoxon Signed Ranks test, Mann-Whitney U test and Friedman test were used for comparative analyses. The findings showed that the TTM-based KR programme had a statistically significant effect on increasing the quality of life, self-efficacy and self-care levels and improving the clinical parameters of the patients in the intervention group. Improvement was observed in the NYHA classification of the patients in the intervention group and 96.9% of them were determined to have passed to the 'movement' stage of TTM. It is recommended that home-based CR programmes should be disseminated and health professionals should be trained in TTM-based interventions to improve the general condition and clinical parameters of HF patients. It is also recommended to investigate the effectiveness of TTM-based training programmes in different patient groups and to evaluate their long-term effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Statistical analyst was blinded

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of heart failure NYHA class I-III Ejection fraction >30% Age 40-75 years Living within the borders of Adana province Having a telephone Volunteering to participate in the study At least primary school graduate

排除标准

  • Unable to participate regularly in the intervention/follow-up Currently enrolled in an active cardiac rehabilitation program Contraindications for cardiac rehabilitation Hypertrophic heart failure Advanced aortic stenosis Angina pectoris Oncological diagnosis Advanced COPD Dialysis treatment Myocardial infarction within the last 6 months Pregnancy Morbid obesity Cognitive dysfunction

研究组 & 干预措施

Control group

No Intervention

Participants in the control group continued routine outpatient cardiology follow-up. Usual care included medical examination, routine clinical monitoring, physician-led medication management when required, and standard verbal recommendations during clinical encounters. They did not receive the Transtheoretical Model-based home education and follow-up intervention during the study period. After study completion, the control group received the educational booklet.

İntervention group

Experimental

Participants in the intervention group received a 12-week nurse-led, Transtheoretical Model-based home education and follow-up programme. The programme included stage-tailored education, symptom monitoring, medication adherence support, daily weight monitoring, salt and fluid management, safe physical activity guidance, healthy nutrition, tobacco control, stress management, motivational interviewing, and individualized behaviour-change planning. Home visits were conducted in weeks 1, 3, 4, 6, 8, and 10. Telephone follow-up was provided in weeks 2, 5, 7, 9, and 11 to review symptoms, medication adherence, weight monitoring, fluid and salt management, physical activity, motivation, barriers to behaviour change, and general clinical status. Post-intervention measurements were conducted in week 12.

干预措施: transtheoretical model-based intervention (Behavioral)

结局指标

主要结局

European Heart Failure Self-Care Behavior Scale

时间窗: 12 weeks

Turkish validity and reliability study of this measurement tool, which measures the self-care behaviors of HF patients, by Baydemir et al. (2013). This scale consists of 12 items, 4 sub-dimensions and a 5-point Likert structure. A low score obtained from the scale indicates high self-care behavior

次要结局

  • Minnesota Living with Heart Failure Questionnaire(12 weeks)
  • General Self-Efficacy Scale(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan ÇELİK

Assistant Professor

Cukurova University

研究点 (2)

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