Rheumatoid ArthritisRA-AppNCT06873607
Effectiveness Evaluation of a Mobile Application for Rheumatoid Arthritis
A study testing mobile app in people with Rheumatoid Arthritis and Mobile Application, run by Kırıkkale University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Mobile Application
- What is being tested?
- mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
University of Health Science Gulhane Training and Research Hospital
Ankara, Yahşihan
University of Health Science Gulhane Training and Research Hospital
Ankara
About this study
Official title: Evaluation of the Effectiveness of a Mobile Application Developed for Individuals With Rheumatoid Arthritis
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
Read more
- 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Mobile Application
- Being tested
- mobile app, Control (Standard treatment)
- Keywords
- rheumatoid arthritis, mobile application, nursing, quality of life, disease activity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile appDevice
Also called standard treatment and care
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.
Control (Standard treatment)Other
Routine medical check-ups and the information provided during these visits
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: mobile app |
| Control | Other | These patients will not use the mobile application and will continue to receive standard treatment and care. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12 weeks after intervention.
Secondary outcomes (7)
Mediterranean Diet Adherence Screener-MEDAS
It consists of 14 items regarding the type of essential fat individuals use in meals, daily olive oil consumption, daily fruit and vegetable portions, daily margarine/butter and red meat consumption, weekly red wine, legumes, fish-seafood, nuts, cakes, and tomato sauce with olive oil consumption. It will be used to evaluate individuals' compliance with the Mediterranean diet. After assigning 1 or 0 points to each item based on the consumption amount, the total score is calculated. A score of ≤ 5 indicates low adherence, 6-9 indicates moderate adherence, and ≥ 10 indicates high adherence.
Measured: Baseline and 12 weeks after intervention
International Physical Activity Questionnaire Short Form-IPAQ-SF
It provides information about the time individuals spend in light, moderate, and vigorous activities and the time they spend sitting. It will be used to determine the physical activity level of individuals. For each activity level, the MET (Metabolic Equivalent) value is multiplied by the number of days and minutes, resulting in a "MET-min/week" score. The obtained value is classified as physically inactive (MET ≤ 600 energy level), insufficiently active (MET = 600-3000 energy level), and sufficiently active (MET ≥ 3000 energy level).
Measured: Baseline and 12 weeks after intervention
The Stanford Health Assessment Questionnaire-HAQ
It is a scale that questions how rheumatological diseases affect the daily lives of individuals.A higher score on the scale indicates functional impairment. The questionnaire assesses the past week and evaluates the patient's difficulty in performing certain activities.
Measured: Baseline and 12 weeks after intervention
Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire-BRAF-MDQ-T
It will be used to determine the fatigue level of individuals with rheumatoid arthritis. It consists of four different subgroups: physical fatigue, fatigue in daily living activities, cognitive fatigue, and emotional fatigue.A higher score on the scale indicates increased fatigue.
Measured: Baseline and 12 weeks after intervention
Perceived Stressed Scale-PSS-14
It will be used to assess patients' perception of stress.A higher score indicates a greater perception of stress.
Measured: Baseline and 12 weeks after intervention
Adaptation to Chronic Illness Scale-ACIS
This scale was developed to assess the adaptation process of individuals with chronic diseases to their illness. It evaluates factors such as patients' compliance with treatment, adaptation to lifestyle changes, and how they cope with the difficulties brought about by the disease.Higher scores on the overall scale and its subdimensions indicate a higher level of adaptation to the illness.
Measured: Baseline and 12 weeks after intervention
Visual Analog Skala-VAS
It will be used to assess the severity of pain experienced by patients. The pain intensity assessment is typically conducted using a 10 cm (100 mm) long horizontal or vertical line, starting with "No Pain" and ending with "Unbearable Pain." The patient marks the appropriate point on the line based on their perceived pain. In this study, the responses provided by patients regarding their pain intensity will be quantified using a 100 mm scale.
Measured: Baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Jul 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Akinci, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873607
- Sponsor's protocol ID
- RA mobile app
- Acronym
- RA-App
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Mobile Application Developed for Individuals With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06873607
- Acronym / sponsor ID
- RA-App / RA mobile app
- Conditions
- Rheumatoid Arthritis, Mobile Application
- Keywords
- rheumatoid arthritis, mobile application, nursing, quality of life, disease activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app care | Experimental | Device: mobile appParticipants 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. |
| Control | Other | Other: Control (Standard treatment)These patients will not use the mobile application and will continue to receive standard treatment and care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile appAlso: standard treatment and careMobile application content: general information about rheumatoid arthritis (causes, symptoms, treatment), lifestyle changes, coping strategies for symptoms, nutrition and exercise recommendations, and daily life considerations. | Device | Mobile app care |
| Control (Standard treatment)Routine medical check-ups and the information provided during these visits | Other | Control |
Primary outcome
Disease Activity Score 28
Time frame: 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
Time frame: 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.
7 secondary outcomes
Mediterranean Diet Adherence Screener-MEDAS
Time frame: Baseline and 12 weeks after intervention
International Physical Activity Questionnaire Short Form-IPAQ-SF
Time frame: Baseline and 12 weeks after intervention
The Stanford Health Assessment Questionnaire-HAQ
Time frame: Baseline and 12 weeks after intervention
Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire-BRAF-MDQ-T
Time frame: Baseline and 12 weeks after intervention
Perceived Stressed Scale-PSS-14
Time frame: Baseline and 12 weeks after intervention
Adaptation to Chronic Illness Scale-ACIS
Time frame: Baseline and 12 weeks after intervention
Visual Analog Skala-VAS
Time frame: Baseline and 12 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile app in people with Rheumatoid Arthritis and Mobile Application, run by Kırıkkale University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Score 28 (time frame: Baseline and 12 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.