Clinical trial NCT06873607: Effectiveness Evaluation of a Mobile Application for Rheumatoid Arthritis
Official title: Evaluation of the Effectiveness of a Mobile Application Developed for Individuals With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Mobile Application
Keywords: rheumatoid arthritis
mobile application
nursing
quality of life
disease activity
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

1. Is the mobile application developed for patients with rheumatoid arthritis effective in improving their quality of life?
2. 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Disease Activity Score 28
timeFrame: Baseline and 12 weeks after intervention
measure: The Rheumatoid Arthritis Quality of Life Questionnaire-RAQoL
timeFrame: Baseline and 12 weeks after intervention.
Secondary outcomes:
measure: Mediterranean Diet Adherence Screener-MEDAS
timeFrame: Baseline and 12 weeks after intervention
measure: International Physical Activity Questionnaire Short Form-IPAQ-SF
timeFrame: Baseline and 12 weeks after intervention
measure: The Stanford Health Assessment Questionnaire-HAQ
timeFrame: Baseline and 12 weeks after intervention
measure: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire-BRAF-MDQ-T
timeFrame: Baseline and 12 weeks after intervention
measure: Perceived Stressed Scale-PSS-14
timeFrame: Baseline and 12 weeks after intervention
measure: Adaptation to Chronic Illness Scale-ACIS
timeFrame: Baseline and 12 weeks after intervention
measure: Visual Analog Skala-VAS
timeFrame: Baseline and 12 weeks after intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Science Gulhane Training and Research Hospital
state: Yahşihan
city: Ankara
country: Turkey
facility: University of Health Science Gulhane Training and Research Hospital
Study officials:
References: