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临床试验/NCT06233721
NCT06233721已完成不适用

Master's Degree Graduate Nurse PhD Student

Cumhuriyet University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Identifying Information Form (IIF)

研究概览

简要总结

This randomized controlled study was conducted to investigate the effects of face-to-face Education and tele-education given to individuals with atrial fibrillation taking oral Anticoagulants on their medication compliance and satisfaction levels.

The study sample comprised 150 individuals. Of them, 50 were assigned to the control Group, 50 in the experimental group 1, and 50 for the experimental group 2.

Data were collected by the Descriptive Information Form, Medication Compliance Notification Scale and Duke Anticoagulant Satisfaction Scale. The Intervention Group 1 Was given face-to-face education. The Intervention Group 2 was given tele-education.

The control group underwent no intervention.

详细描述

This randomized controlled study was conducted to investigate effects of face-to-face education and tele-education given to individuals with atrial fibrillation taking oral anticoagulants on their medication compliance and satisfaction levels. The study sample comprised 150 individuals. Of them, 50 were assigned to the control group, 50 to the experimental group 1, and 50 to the experimental group 2. Data were collected with the Descriptive Information Form, Medication Compliance Notification Scale and Duke Anticoagulant Satisfaction Scale. The Intervention Group 1 was given face-to-face education. The Intervention Group 2 was given tele-education.

The control group underwent no intervention. The scales were administered to all the groups twice, at the first and last interviews. Frequency, percentage calculation, Chi-square test, significance test between two means, one-way analysis of variance, Wilcoxon sign test, Fisher test, Bonferroni test and dependent groups t test were used in the analysis of data. The intra-group analysis demonstrated that the Medication Compliance Notification Scale score of the intervention group 1 (face-to-face education group) increased significantly in the final measurement compared to those of the control group and intervention group 2 (tele-education group) (p=.000). The inter-group analysis demonstrated that Duke Anticoagulant Satisfaction Scale scores of the three groups statistically significantly different. The difference stemmed from the intervention group 1.

Face-to-face education given to individuals with atrial fibrillation on oral anticoagulants improved their medication compliance and medication satisfaction levels. Nurses should primarily use face-to-face education in the care and education programs of individuals with atrial fibrillation.

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
Double (Participant, Investigator)

盲法说明

Individuals who agreed to participate in the study were randomly assigned to intervention and control groups by using a randomizer (http://www.randomization.com). 150 individuals who were included in the study were randomly split into three groups by a person other than the researcher, and the three groups were given a code name. In order to generate random numbers for randomization (from 1 to 50), a software was used. Thus, determined numbers for each group were obtained. Both the participants and the researchers were blinded in group assignment.

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

  • 18 years and over
  • Diagnosed with Atrial fibrillation (AF) for at least a year
  • Had been using oral anticoagulant (OACs) for at least 3 months
  • Had a smart phone
  • Had not previously taken any training on oral anticoagulant medication treatment

排除标准

  • The individuals who had disorders that would affect training and experienced complications such as active hemorrhage related to oral anticoagulant use

结局指标

主要结局

Identifying Information Form (IIF)

时间窗: 1 month

The form developed by the researchers by reviewing the literature consisted of 14 questions regarding the individuals' sociodemographic characteristics (age, gender, marital status, occupation, etc.) and disease characteristics (presence of a chronic disease, etc.)

Medication Adherence Report Scale (MARS)

时间窗: 1 month

The 5-point Likert type scale has five items. The total scale score is calculated by summing all item scores. The score to be obtained from the scale ranges between 5-25. High scores obtained from the scale show better medication adherence.

Duke Anticoagulation Satisfaction Scale (DASS)

时间窗: 1 month

The 7-point Likert type scale has 25 items under three subscales. High scores obtained from the scale show low medication satisfaction. The highest and lowest scores to be obtained from the scale are 175 and 25, respectively.

次要结局

未报告次要终点

研究者

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

Harun Küçükballı

Graduate Student, Responsible Researcher

Cumhuriyet University

研究点 (2)

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