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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
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Other | These patients will not use the mobile application and will continue to receive standard treatment and care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile app | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Science Gulhane Training and Research Hospital | Ankara | Yahşihan | Turkey (Türkiye) | |||
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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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Control (Standard treatment) | Other | Routine medical check-ups and the information provided during these visits |
|
| 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). | 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. | 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. | 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. | 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. | 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. | Baseline and 12 weeks after intervention |
| University of Health Science Gulhane Training and Research Hospital |
| Ankara |
| Turkey (Türkiye) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |