The goal of this single-blind, randomized controlled trial is to evaluate the clinical effectiveness and short-term economic impact of a mobile application-based, personalized yoga and meditation program in adult patients with Rheumatoid Arthritis (RA). The main questions it aims to answer are: Does an 8-week digital yoga and meditation intervention reduce anxiety and improve other clinical/psychological outcomes (such as depression, pulmonary function, reaction time, quality of life, and stress) compared to standard medical care? Does this digital intervention reduce short-term healthcare utilization and associated direct medical costs? Researchers will compare the Mobile App Group (receiving personalized yoga and meditation via the Meditopia app) to a Control Group (receiving usual medical care) to evaluate the effectiveness and cost-efficiency of the intervention. Participants in the experimental group will: Use a mobile application to practice 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week over an 8-week period. Complete clinical, psychometric, and economic assessments at baseline, week 4, and week 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
102
The intervention consists of an 8-week individualized program. It includes yoga sequences selected by a physiotherapist based on the patient's functional capacity and joint mobility. It also includes mindfulness-based and emotion regulation-focused meditation content selected by a clinical psychologist. Participants are expected to practice for 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week.The intervention is delivered through the Meditopia mobile application.
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology
Istanbul, Istanbul, Turkey (Türkiye)
Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
Evaluated using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The HADS-A is a 7-item self-report scale scored from 0 to 21. Higher scores indicate a greater symptom burden of anxiety.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2).
Perceived Stress Scale (PSS-10)
Measured by the Perceived Stress Scale (PSS-10), a 10-item tool (scored 0-40) assessing how unpredictable or uncontrollable patients find their lives.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a 9-item self-report scale used to evaluate the impact of fatigue on daily functioning and social life. Each item is scored on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of the 9 items, with a final score ranging from 1 to 7. A higher mean score indicates a greater severity of fatigue and a more significant impact of fatigue on the individual's daily activities.
Time frame: Baseline and Week 8
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess sleep quality and disturbances over a one-month time interval. It evaluates seven 'component' scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21. A total global score of greater than 5 is generally used to indicate poor sleep quality. Higher global scores represent poorer sleep quality and more significant sleep disturbances.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Rheumatoid Arthritis Quality of Life (RAQOL)
The Rheumatoid Arthritis Quality of Life (RAQOL) questionnaire is a disease-specific instrument designed to assess the quality of life in patients with rheumatoid arthritis using a needs-based model. It consists of 30 items with a binary response format (Yes/No). Each 'Yes' response is scored as 1, and each 'No' response is scored as 0. The total score ranges from 0 to 30, with higher scores representing a poorer quality of life and a greater negative impact of the disease on the individual's life. The scale focuses on various domains, including mood, social life, hobbies, everyday tasks, and physical contact.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Chronic Illness Self-Management (CISM) Scale
The Chronic Illness Self-Management (CISM) scale is a 23-item tool designed to assess the self-management behaviors and perceptions of individuals living with chronic conditions. It consists of four subscales: Self-Stigma (7 items), Coping with Stigma (5 items), Healthcare Effectiveness (5 items), and Treatment Adherence (6 items). Each item is evaluated based on the patient's experience, providing a comprehensive measure of how well the individual manages the challenges associated with their illness. Higher scores in specific domains indicate better self-management capabilities and adaptation to the chronic condition.
Time frame: Baseline (T0) and Week 8 (T2)
Forced Vital Capacity (FVC)
Quantitative measurement of respiratory function will be performed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols. FVC (expressed in Liters) will be recorded in a seated position to assess the presence and severity of extra-articular pulmonary involvement. The best of at least three acceptable maneuvers will be used for analysis.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Forced Expiratory Volume in 1 Second (FEV1)
Quantitative measurement of respiratory function assessed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols. FEV1 measures the volume of air exhaled in the first second of the forceful exhalation.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
FEV1/FVC Ratio
The ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity, calculated from the spirometry maneuver to assess obstructive or restrictive pulmonary patterns.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Peak Expiratory Flow (PEF)
Quantitative measurement of respiratory function assessed using a calibrated spirometer in accordance with the ATS/ERS standardization protocols. PEF measures the maximum speed of expiration.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Visual Reaction Time (BlazePod)
Visual reaction time will be measured using the BlazePod device, a portable visual-cognitive technology designed to assess response speed to light stimuli. Simple and selective reaction time tasks will be performed where participants respond by touching or tapping the pod when it illuminates. To ensure reliability, each participant will complete multiple trials (typically 5-10), and the average reaction time in milliseconds will be calculated after excluding outliers. The testing procedure will be standardized regarding lighting conditions, distance, and participant positioning. This measurement serves as a neurocognitive performance indicator to evaluate the systemic and cognitive effects of the intervention.
Time frame: Baseline (T0), Week 4 (T1), and Week 8 (T2)
Total Direct Healthcare Costs (Partial Cost Analysis)
A partial cost analysis will be conducted from a healthcare system perspective to evaluate the short-term economic impact of the digital intervention. Data on healthcare resource utilization-including the number of planned or unplanned rheumatology/internal medicine outpatient visits, emergency room admissions, and the number and duration of hospitalizations-will be collected retrospectively for the 8-week period using a structured 'Healthcare Utilization Questionnaire'. To calculate the total direct medical cost per patient, these frequency data will be multiplied by official unit costs derived from the current Social Security Institution (SGK) Health Implementation Communiqué (SUT) tariffs and supported by relevant cost-of-illness literature in Turkey. This analysis aims to provide preliminary empirical evidence on the cost-effectiveness of integrating mobile mind-body interventions into the routine management of Rheumatoid Arthritis.
Time frame: Baseline (T0) and Week 8 (T2)
System Usability Scale (SUS)
The System Usability Scale will be administered only to participants in the intervention group to evaluate the usability, ease of use, and overall acceptability of the digital system used during the intervention. The SUS is a validated 10-item questionnaire scored on a 5-point Likert scale. Total scores range from 0 to 100, with higher scores indicating better perceived usability and user satisfaction with the system.
Time frame: At the end of the 8-week intervention
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