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临床试验/NCT04607681
NCT04607681已完成不适用

Evaluation of the Effect of Web-designed Training Developed for Asthma Patients on Drug Compliance, Asthma Control, and Fatigue

Eskisehir Osmangazi University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
change from baseline in bility to use inhalation devices at week 6

研究概览

简要总结

The study is an experimental study with pre-test-post-test control group in order to determine the effect of web-designed training developed for asthma patients on drug compliance, asthma control, and fatigue

详细描述

In the first stage, it is aimed to develop, implement and evaluate a web designed asthma education program for asthma patients. In the second stage, it is to evaluate the effect of the web-designed education program developed for asthmatic patients on drug ompliance, asthma control, and fatigue The population of the study consists of patients diagnosed with asthma who are registered in Family Health Centers in Eskişehir. The individuals that constitute the target group in the study will be determined through the records of patients diagnosed with asthma registered in the family health center or the list of patients in the J45-Asthma and J46 Status Asthmaticus ICD codes. The sample of the study will be the patients who meet the criteria for inclusion in the study. G power analysis program was used to determine the sample size. The research will be conducted in two groups, an intervention and a control group. The sample size of the research was found to be 200.

In collecting research data; The personal descriptive characteristics form prepared by the researcher, the questionnaire for determining the information needs, Form for evaluation of the skills of using inhalation devices and the opinion form regarding the web-based asthma education program will be used. At the same time, COPD and asthma fatigue scale, drug compliance reporting scale and Asthma Control Test (AKT) will be used.

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, Outcomes Assessor)

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,
  • Those who have been diagnosed with asthma for at least one year
  • Those with poor asthma control
  • Using at least one asthma medication
  • Not having a communication problem, such as inability to understand/speak Turkish, that would prevent participating in the research or receiving training,
  • Being literate,
  • Having an internet connection at home or on their phone,
  • Having and using a computer, tablet or smart phone,
  • Patients who accepted to participate in the study voluntarily formed the sample of the study.

排除标准

  • No internet connection at home or on their phone,
  • Do not know how to use the Internet and computer,
  • Having a communication problem, such as inability to understand/speak Turkish, that would prevent participating in the research or receiving training,
  • Illiterate,
  • Diagnosed with another respiratory system disease,
  • Diagnosed with cancer or undergoing cancer treatment,
  • Those who have been diagnosed with or have had COVID-19,
  • Individuals with a psychiatric illness were not included in the study.

结局指标

主要结局

change from baseline in bility to use inhalation devices at week 6

时间窗: baseline and 6 weeks

Form for evaluation of the skills of using inhalation devices

change from baseline in Medication Compliance Reporting Scaleat week 6

时间窗: baseline and 6 weeks

Medication Compliance Reporting Scale Participants are asked to indicate the frequency of the 5 statements in each of them. The scale is evaluated with a 5-point Likert type such that 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. The total test score is obtained by summing the scores obtained from the items. The scores obtained from the scale range from 5 to 25. An increase in the obtained scores indicates compatibility, and a decrease in scores indicates incompatibility.

change from baseline in COPD and Asthma Fatigue Scale (DAS) at week 6

时间窗: baseline and 6 weeks

COPD and Asthma Fatigue Scale (DAS) The scale consists of 12 items, and a Likert type rating (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = very often) is used for its answers. In calculating the scale score, the first 10 questions correspond to never = 1 point, rarely = 2 points, sometimes = 3 points, often = 4 points, very often = 5 points, and in the 11th and 12th questions never = 5 points, rarely = 4 points. , sometimes = 3 points, often = 2 points, very often = 1. The total raw score is determined by adding the scores of each item and the raw scores are converted into a total scale score between 0-100. The higher the score obtained from the scale indicates that the fatigue level of the person is high.

change from baseline in Asthma Control Test (AKT) at week 6

时间窗: baseline and 6 weeks

Asthma Control Test (AKT); This scale consists of five Likert type and consists of five questions. The maximum score of this test is 25 and the minimum score is 5, while 25 points are "full control", 20-24 points "good control" and a score of less than 19 is considered "uncontrolled"

evaluating the web-based asthma education program

时间窗: at 6 weeks

Opinion Form Regarding the Web Based Asthma Education Program This form contains 20 questions prepared to determine the views of asthma patients on the web-based asthma education program.

次要结局

未报告次要终点

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

EYLUL GULNUR ERDOGAN, Phd

PHD STUDENT

Eskisehir Osmangazi University

研究点 (1)

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