NCT06873607

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 13, 2026

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

March 7, 2025

Last Update Submit

April 8, 2026

Conditions

Keywords

rheumatoid arthritismobile applicationnursingquality of lifedisease activity

Outcome Measures

Primary Outcomes (2)

  • Disease Activity Score 28

    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.

    Baseline and 12 weeks after intervention

  • The Rheumatoid Arthritis Quality of Life Questionnaire-RAQoL

    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.

    Baseline and 12 weeks after intervention.

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Mobile app care

EXPERIMENTAL

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.

Device: mobile app

Control

OTHER

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

Other: Control (Standard treatment)

Interventions

Mobile application content: general information about rheumatoid arthritis (causes, symptoms, treatment), lifestyle changes, coping strategies for symptoms, nutrition and exercise recommendations, and daily life considerations.

Also known as: standard treatment and care
Mobile app care

Routine medical check-ups and the information provided during these visits

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Health Science Gulhane Training and Research Hospital

Ankara, Yahşihan, Turkey (Türkiye)

Location

University of Health Science Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 12, 2025

Study Start

July 1, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

April 13, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

The sharing of individual patient data is not feasible due to the sensitive nature of the data and the potential risks of re-identification, which could compromise patient confidentiality. The study design and the intended use of the data do not require IPD sharing. The focus will be on aggregate analysis and summary results, which do not involve the release of individual patient-level data.

Locations