跳至主要内容
临床试验/NCT07139080
NCT07139080已完成不适用

The Effect of Mobile Application-Based Education on Self-Efficacy, Medication Adherence and Sleep Quality in Asthma Patients.

Gulhane Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年12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
发起方
入组人数
68
试验地点
1
主要终点
Chronic Disease Self-Efficacy

研究概览

简要总结

Asthma patients with recurrent airway obstruction frequently exhibit poor symptom control, characterized by treatment non-adherence and sleep-wake cycle disturbances. A nurse-led mobile health education intervention may address these challenges by enhancing collaborative disease management, enabling remote patient monitoring, and strengthening self-management competencies.

The AstımAsistan application was designed to monitor changes in patient self-efficacy, medication adherence, and sleep quality through three core features: (1) patient education modules, (2) breathing exercise/medication reminders, and (3) mobile consultation capabilities.

Study data were collected using four instruments: (1) the Participant Information Form, (2) the Chronic Disease Self-Efficacy Scale, (3) the Medication Adherence Reporting Scale, and (4) the Pittsburgh Sleep Quality Index. The mobile education-based application was developed following the ADDIE (Analysis, Design, Development, Implementation, and Evaluation) instructional design model."

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 (Participant)

盲法说明

Randomization will be performed according to disease duration via calculatorsoup.com, a web-based program. It will be defined as the intervention group (M) and the control group (K). During the randomization process, numbered envelopes will be prepared by an academician outside the research for the patients included in the intervention and control groups. The researcher will learn the information about the intervention or control group in the prepared envelopes when the relevant envelope is opened during the interview with the patient. Thus, statistical blinding will be ensured.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being between the ages of 18-65
  • •Having been diagnosed with asthma at least 6 months ago
  • •Being treated for asthma in oral, inhaler or injection forms
  • •Being literate in Turkish
  • •Having an Android phone on which the mobile application can be installed and being able to use the phone
  • •Having mobile network or wireless internet access
  • •Volunteering to participate in research
  • •Living in Ankara

排除标准

  • •Being hospitalized for asthma treatment
  • •Having a language barrier that hinders communication
  • •Being diagnosed with COPD
  • •Being diagnosed with a psychiatric disease
  • •Being on psychoactive or opioid therapy
  • •Being diagnosed with a sleep disorder related to non-respiratory reasons (physical and psychological) and being treated
  • •Exclusion criteria when the study is going on :
  • •Intervention group;
  • •The participant was diagnosed with a health problem requiring inpatient treatment during the study period.
  • •The participant withdraws from the study voluntarily.
  • •Inability to use the mobile application during the research
  • •Reading fewer than 6 theme headings in the mobile application (75% or less) and missing breathing exercises for more than 16 days (80% or less)
  • •Control group;
  • •The participant was diagnosed with a health problem requiring inpatient treatment during the study period.
  • •The participant withdraws from the study voluntarily.

研究组 & 干预措施

Mobile Education Group

Experimental

It consists of participants who will download the mobile patient education and breathing exercise reminder program and apply it for 10 weeks.

干预措施: Mobile education (Behavioral)

Control Group

No Intervention

This is the group of participants to be followed within the standard treatment plan. A mobile training and breathing exercise reminder program will be downloaded to patients in this group at the end of the study.

结局指标

主要结局

Chronic Disease Self-Efficacy

时间窗: 10 weeks

Chronic Disease Self Efficacy Scale: In this 30-item scale, each question is scored between 1 and 10 points to determine the level of self-efficacy. The total score obtained by the individual from the scale is divided by the number of items to calculate an overall self-efficacy average. The scale also has 10 subtitles. If the 30 items' average is below 7, it means the individual has low self-efficacy. If the average is 7 or above, it indicates that the individual has high self-efficacy regarding their illness and believes they can achieve their goals."

Medication Adherence

时间窗: 10 weeks

The Medication Adherence Report Scale (MARS), developed by Horne and Hankins (2001), can be adapted based on disease type. The scale requires participants to indicate the frequency of occurrence for 5 specific statements in themselves. The scoring uses a Likert-type scale where: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always. The total test score is obtained by summing the scores from all items. The minimum possible score on the scale is 5, and the maximum is 25. Higher scores indicate compliance, while lower scores suggest non-compliance.

Sleep Quality

时间窗: 10 weeks

PSQI is developed by Buysse et al. in 1989, this scale is used to assess sleep quality and identify factors contributing to sleep disorders. Its validity and reliability for our country were established by Ağargün et al. The scale consists of 18 scored items grouped into 7 component scores, with each item rated on a 0-3 scale. The components are: Subjective Sleep Quality Sleep Latency Sleep Duration Habitual Sleep Efficiency Sleep Disturbances Use of Sleep Medication Daytime Dysfunction The total scale score is calculated by summing the seven component scores. A total score of 5 or higher indicates poor sleep quality.

次要结局

未报告次要终点

研究者

发起方
Gulhane Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ezgi Yildirim

Principal İnvestigator

Gulhane Training and Research Hospital

研究点 (1)

Loading locations...

相似试验