M06 M05 M07 M45.0 M32.1 M32.8 M32.9 M13
Conditions
Interventions
Group 1: Use of the App RheCORD plus standard rheumatology care
Group 2: standard rheumatology care
Sponsors
RheCORD GmbH & Co KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - No use of the RheCORD plus app or the predecessor app RheCORD Home so far - Present diagnosis of one of the following diseases: o Rheumatoid arthritis (ICD10 M05.-, M06.-) o Psoriatic arthritis (ICD10 M07.-) o Axial spondyloarthritis (ICD10 M45.0-) o Systemic lupus erythematosus with joint involvement (ICD10 M32.1, M32.8, M32.9) o Undifferentiated arthritis (ICD10 M13.-) - Duration of disease = 1 year (since diagnosis) - Stable antirheumatic therapy in the last 12 weeks - Age: = 18 years - Able to give informed consent, signed informed consent form for participation in the study. - In possession of and able to use a smartphone compatible with the RheCORD minimum Android or iOS requirements. - Willingness and ability to complete the pre-evaluation assessments for the required 12-week participation period. - RheCORD reminder function for upcoming assessments. - Willingness to use the self-care module on an ongoing basis
Exclusion criteria
Exclusion criteria: - Lack of capacity to consent - Age < 18 years - Inflammatory rheumatic diseases other than those mentioned above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain NRS - PHQ-4 (Patient Health Questionnaire 4) - MSCS-S (Mindful Self-Care Scale Standard) - MSCS-S additional scale for general self-care activities - RAID (Rheumatoid Arthritis Impact of Disease Questionnaire) or PsAID (Psoriatic Arthritis Impact of Disease Questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| PHQ-4 at week 12 (+4): § Depression subscale § Anxiety" subscale MSCS-33 at week 12 (+4): - Mindful Relaxation subscale - Physical Self-Care subscale - Self-Compassion and Meaning in Life subscale - Supportive Relationships" subscale - Supportive Structures subscale - Mindful Awareness subscale SECONDARY FINAL POINTS without gatekeeping reference - Number of contacts made between patient and study centre during the study period - Number of interventions that took place after contact between patient and study centre - Physician-based assessment of rheumatic disease activity (NRS) after 12 (+4) weeks of study participation - WPAI-GH after 12 (+4) weeks - Indication-specific disease activity indices: ASDAS (CRP), DAPSA, DAS28(CRP)/CDAI/SDAI at 12 (+4) weeks. - Average change in NRS (pain) from week 0 to week 12 (+4) - Average change in PHQ-4 from week 0 to week 12 (+4) - Average change in MSCS-S from week 0 to week 12 (+4) - Average change in MGL from week 0 to week 12 (+4) - Average change in RAID/PsAID from week 0 to week 12 (+4) - Proportion of patients with Patient Acceptable Symptom State (PASS) at week 12 (+4) - Proportion of patients in remission in the following indications according to the following criteria at week 12 (+4) o RA: SDAI = 3.3 o PsA: DAPSA = 4 o axSpA: ASDAS-CRP < 1.3 o SLE: DORIS remission, i.e. SLEDAI = 0 & PGA < 0.5 (correspondingly in this study instead of PGA < 0.5: physician NRS activity < 2) | — |
Countries
Germany
Contacts
Public ContactStefan Kleinert
Praxisgemeinschaft Rheumatologie Nephrologie
Outcome results
None listed