M05 M06
Conditions
Interventions
Group 1: 94 subjects with RA planned to use Mida Rheuma App added to care as usual (Mida Rheuma App group)
The study will consist of 2 study periods:
Screening period: up to 30 days with study visit 1.
Observational period: 12 weeks with 3 study visits (Day 1, week 6, week 12).
Subjects will participate in
Sponsors
Midaia GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adult subjects (male or female) 18 years and over that meet the corresponding specific classification criteria of RA (ICD-10 M05 and M06, according to classification criteria: RA, ACR/ European League Against Rheumatism (EULAR) 2010). - German-speaking person who has a smartphone and an e-mail account, and is able to use both of them - If using Disease-modifying antirheumatic drugs (DMARDs) therapy, subjects are permitted to use any conventional synthetic (csDMARDs), targeted synthetic (tsDMARDs) or biological (bDMARDs), alone or in combination and must have been on a stable dose of the drug for at least 4 weeks prior to study inclusion day. - If taking systemic or steroids, must have been on a stable dose of the drug for at least 4 weeks prior to study inclusion day. - If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior to study inclusion day. - Disease activity of =>6.1 according to RAPID3 at baseline.
Exclusion criteria
Exclusion criteria: - Presence of disorders which, in the opinion of the investigator, significantly complicate the work with the phone that would prevent or substantially complicate Mobile Application use. These disorders can include but are not limited to mental disorders or functional impairment (e.g., physical impairments). - The subject has any condition or circumstances that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements. - History of other inflammatory arthritis, or combination of RA with psoriatic arthritis (PsA), ankylosing spondylitis (AS), or axial spondyloarthritis (axSpA). - Patients with acute fever, acute viral or bacterial infections, other autoimmune diseases (i.e., MS), other severe diseases (i.e., congestive heart failure, heart attack), and uncontrolled conditions: apoplexy, seizures, Parkinson's disease, severe COPD or allergic diseases. - Patients taking antibiotics and antihistamine. - Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening. - The subject for whom a change in arthritis treatment is planned since the start of screening within the next 17 weeks. - Previous use of any Midaia Software or equivalent digital therapeutic in the past 12 months. - The female subject is pregnant or breast feeding or intending to become pregnant or breastfeeding during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There is no differentiation between primary and secondary endpoints. The following endpoints are evaluated: To evaluate the effect of the Mida Rheuma App on patients' disease activity in addition to care as usual versus care as usual only in the treatment of participants with RA, measured through Routine assessment of patient index data 3 (RAPID3). To evaluate the effect of the Mida Rheuma App on patients' Quality of Life in addition to care as usual versus care as usual in the treatment of participants with RA, measured by Short Form Health Survey (SF-36). To evaluate the effect of the Mida Rheuma App on patients' Health Literacy in addition to care as usual versus care as usual in the treatment of participants with RA, measured by European Health Literacy Survey Questionnaire (HLS-EU-Q16). To evaluate the effect of the Mida Rheuma App on patients' Self-Efficacy in addition to care as usual versus care as usual in the treatment of participants with RA, measured by Arthritis Self-Efficacy Scale-8 (ASES-8). To evaluate the effect of the Mida Rheuma App on patients’ Mental Health in addition to care as usual versus care as usual in the treatment of participants with RA, measured by Patient Health Questionnaire-9 (PHQ-9). To evaluate the safety of Mida Rheuma App use, measured by number of adverse events (AEs), severity rate of AEs, relationship of AEs with IP. | — |
Secondary
| Measure | Time frame |
|---|---|
| No distinction is made between primary and secondary endpoints. All endpoints were reported under primary endpoints. | — |
Countries
Germany
Contacts
Public ContactChristine Peine
Midaia GmbH
Outcome results
None listed