Effectiveness Evaluation of a Mobile Application for Rheumatoid Arthritis (RA-App)

Kırıkkale University

Status: Not yet enrolling

Conditions: Mobile Application; Rheumatoid Arthritis

Treatments: Device: mobile app; Other: Control (Standard treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT06873607

RA mobile app

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Mobile app care

Experimental group

Description:

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.

Treatment:

Device: mobile app

Control

Other group

Description:

These patients will not use the mobile application and will continue to receive standard treatment and care.

Treatment:

Other: Control (Standard treatment)