跳至主要内容
临床试验/NCT05418478
NCT05418478进行中(未招募)不适用

The Effect of Training Given to Patients With Heart Failure Through Transtheoretic Model-based Telehealth Methods on Self-care, Drug Adherence and Quality of Life

Harran University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
2
主要终点
European Heart Failure Self-Care Behaviors Scale

研究概览

简要总结

This study was planned as a randomized, controlled, experimental study to evaluate the effects of transtheoretic model-based education on self-care, drug compliance and quality of life in patients with heart failure. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses in follow-up and considering that non-parametric tests can be performed, the research group will consist of a total of 72 people, 36 in each group, with an increase of 20%. Patients with heart failure who do not have communication barriers to affect cognitive functions, can use tele-health applications (Smartphone and application), volunteers aged 18 and over and agree to participate in the study will be included in the intervention and control groups. The data of the study, "Socio-demographic Characteristic Data Form", "Question Form Regarding the Disease", "European Heart Failure Self-Care Behaviors Scale-12", "Beliefs About Medication Adherence Scale," in which socio-demographic characteristics and information about the disease were questioned. (IUHIO)'' and ''Minnesota Life with Heart Failure Questionnaire''.

详细描述

The patients in the intervention group will be trained through tele-health practices for at least 25-30 minutes on a transtheoretical basis, every 2 weeks in the 1st month and once a month in the following months. Tele-health applications include phone monitoring, SMS notification and application applications. Educational topics based on model-based self-care behaviors; It will include regular exercise, nutrition-weight monitoring, fluid intake-edema control, smoking cessation, regular drug use, regular rest, vaccination. Educational principles will be shared with patients by SMS from time to time during the education process. Treatment compliance levels and self-care behaviors of both groups of patients will be re-measured from the first week to the 6th month after the training, and any difference will be analyzed using statistical methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator)

入排标准

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

入选标准

  • Have no communication barriers to affect cognitive functions,
  • Ejection-Fraction over 20
  • Diagnosed with Heart Failure for at least 6 months
  • Able to use tele-health applications (smartphone and application)

排除标准

  • Patients with communication difficulties
  • Patients who cannot use tele-health applications

结局指标

主要结局

European Heart Failure Self-Care Behaviors Scale

时间窗: Baseline-6 months

The scale includes recognizing symptoms such as edema and weight gain, dyspnea, and fatigue associated with heart failure; It consists of 12 questions to measure self-care behaviors such as applying to a doctor and nurse for these symptoms, regular use of drugs, use of fluid and salt, treatment such as diet and exercise regimen and self-care behaviors such as weight monitoring and edema monitoring.

次要结局

  • Medication Compliance Notification Scale(Baseline-6 months)
  • Minnesota Life with Heart Failure Survey(Baseline-6 months)
  • New York Heart Association classification (NYHA)(Baseline-6 months)

研究者

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

İbrahim Caner Di̇ki̇ci̇

Lecturer

Harran University

研究点 (2)

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