Evaluation of the Effectiveness of a Mobile Application Developed for Individuals With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Disease Activity Score 28
研究概览
简要总结
The aim of this experimental study is to develop a mobile application for patients with rheumatoid arthritis based on evidence-based recommendations and to evaluate the effectiveness of the developed application.
Research Questions
- Is the mobile application developed for patients with rheumatoid arthritis effective in improving their quality of life?
- Is the mobile application developed for patients with rheumatoid arthritis effective in reducing their disease activity? The researchers will enable the intervention group to use the mobile application in order to assess its effectiveness, while the control group will receive routine care throughout the study period.
Participants in the intervention group will use the mobile application for 12 weeks. Changes in the parameters determined by the researchers will be examined before and after the usage period. Patients in the control group will be evaluated after the initial consultation and at the end of 12 weeks. At the conclusion of the study, the control group will also be provided access to the mobile application.
详细描述
The mobile application will include general information about the disease, written and audio materials on disease management, as well as videos on exercise and nutrition recommendations. Stratified randomization based on disease activity will be applied to determine the patients in the intervention and control groups. Patients in the intervention group will be encouraged to use the content available in the application through pre-programmed smartphone notifications.
Data collection forms, including the Patient Sociodemographic and Medical Characteristics Form, Disease Activity Score 28 (DAS-28), The Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL), Mediterranean Diet Adherence Screener (MEDAS), International Physical Activity Questionnaire Short Form (IPAQ-SF), Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ-T), Perceived Stress Scale (PSS-14), Adaptation to Chronic Illness Scale (ACIS), and Visual Analog Scale (VAS) for Pain Assessment, will be administered at the initial encounter with the patients and again after 12 weeks, as specified in the methods section.
The collected data will be analyzed using the SPSS program. After the study is completed, the mobile application will be installed on the smartphones of the patients in the control group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older
- •Diagnosis of Rheumatoid Arthritis according to the American College of Rheumatology (ACR) 1987 criteria
- •Receiving stable treatment for the last 3 months with no new treatments added at the last check-up
- •Ability to read and write in Turkish
- •Ownership of a personal smartphone with internet connectivity and the ability to use an application
- •Willingness to participate in the study
排除标准
- •Pregnancy or breastfeeding
- •Having a diagnosis of inflammatory diseases or a disease that may significantly affect the functional status (such as Multiple Sclerosis, stroke, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Psoriatic Arthritis)
- •Not having any neurological or psychiatric disease/problem diagnosed by a physician
- •Wanting to withdraw from the study
- •Exiting during the study process
- •Not logging in to the mobile application once a week during the study implementation period (twelve weeks) for the intervention group
研究组 & 干预措施
Mobile app care
Participants in this group will receive mobile application-supported care for 12 weeks, along with the recommended treatment. The content of the mobile application will include information about the disease, recommended lifestyle changes, as well as exercise and nutrition suggestions.
干预措施: mobile app (Device)
Control
These patients will not use the mobile application and will continue to receive standard treatment and care.
干预措施: Control (Standard treatment) (Other)
结局指标
主要结局
Disease Activity Score 28
时间窗: Baseline and 12 weeks after intervention
It is a scoring system used to determine the disease activity of rheumatoid arthritis. Calculation is made by evaluating the number of tender and swollen joints, erythrocyte sedimentation rate, global assessment of the patient, and VAS measurements using a special type of calculator. Based on the obtained DAS score, DAS 28 ≤ 2.4 is considered remission, 2.4-3.6 indicates low disease activity, 3.6-5.5 indicates moderate disease activity, and ≥ 5.5 is classified as high disease activity.
The Rheumatoid Arthritis Quality of Life Questionnaire-RAQoL
时间窗: Baseline and 12 weeks after intervention.
It will evaluate the quality of life of individuals with rheumatoid arthritis.The obtained result ranges from 0 to 30, with higher scores indicating poorer quality of life.
次要结局
- Mediterranean Diet Adherence Screener-MEDAS(Baseline and 12 weeks after intervention)
- International Physical Activity Questionnaire Short Form-IPAQ-SF(Baseline and 12 weeks after intervention)
- The Stanford Health Assessment Questionnaire-HAQ(Baseline and 12 weeks after intervention)
- Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire-BRAF-MDQ-T(Baseline and 12 weeks after intervention)
- Perceived Stressed Scale-PSS-14(Baseline and 12 weeks after intervention)
- Adaptation to Chronic Illness Scale-ACIS(Baseline and 12 weeks after intervention)
- Visual Analog Skala-VAS(Baseline and 12 weeks after intervention)
研究者
Merve Akinci
Msc
Kırıkkale University