M15-M19
Conditions
Interventions
Group 1: Intervention group:
AR-enhanced education
Group 2: Control group:
Standard patient education
Sponsors
Justus- Liebig Universität Gießen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis of RA according to ACR/EULAR 2010 classification criteria 2. Adult male or female subject; age =18 years 3. RA patients with a Clinical Disease Activity Score (cDAI) > 10 (at least moderate disease activity) 4. Patient self-assessment of patient education regarding open questions and missing information for the underlying disease („feeling very well educated (no open questions / no missing information)“, „good educated“, „moderately educated“, „poorly educated“, „feeling completely uneducated (only open questions and missing information)“) with a response of feeling „moderately educated“ or worse 5. Patients with more than one RA treatment in the past medical history 6. Patients who receive treatments that need to be taken more for more than one month 7. Able and willing to give written informed consent. 8. Adequate compliance
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any other rheumatological/immunological disease than RA 2. Dementia, epilepsy or any other neurologic disease prohibiting the use of Augmented Reality technology 3. Sensitivity to fast change of light or flashing lights or fast movements 4. Stroke in the last 6 months 5. Employee or direct relative of an employee of the study site, or the sponsor 6. Receiving i.v. RA treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The difference from baseline to 4 weeks after intervention (V3) between the two groups (intervention/ control) in the Brief Illness Perception Questionnaire (BIPQ). 2. Other endpoints for the primary objective: The following timepoints will be also be assessed: o baseline (V1) o after intervention (V2) o 4 weeks after intervention (V3) o 12 weeks after intervention (V4) o 24 weeks after intervention (V5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute value and change from baseline at 4 weeks (V3) in the Beliefs about Medicines Questionnaire(BMQ). 2. Absolute value and change from baseline at 12 weeks (V4) in adherence measured by the Compliance Questionnaire for Rheumatology(CQR5). 3. Absolute value and change from baseline at 12 weeks (V4) in disease activity of rheumatoid arthritis measured by the Simplified Disease Activity Index (sDAI) and Clinical Disease Activity Index (cDAI). 4. Other endpoints for the secondary objectives: The following timepoints will be also be assessed: o baseline (V1) o 4 weeks after intervention (V3) [only for BMQ and CQR5] o 12 weeks after intervention (V4) o 24 weeks after intervention (V5) | — |
Countries
Germany
Contacts
Public ContactPhilipp Klemm
Campus Kerckhoff der Justus-Liebig-Universität Gießen, Abteilung für Rheumatologie und Klinische Immunologie, Kerckhoff Klinik
Outcome results
None listed