Influence of Rheumatologists on Therapy Adherence in Patients with Inflammatory Rheumatic Diseases – The Prospective Multicenter DRAMA Study

Influence of Rheumatologists on Therapy Adherence in Patients with Inflammatory Rheumatic Diseases – The Prospective Multicenter DRAMA Study - (DmaRd Adherence in rheuMatic diseAses)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036957

Enrollment

200

Registered

2025-05-19

Start date

2025-06-02

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory rheumatic diseases, specifically seropositive rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

Interventions

Group 1: cDMARD Cohort Patients with rheumatoid arthritis or psoriatic arthritis who are being initiated on a conventional synthetic disease-modifying antirheumatic drug (cDMARD) for the first time. T

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Cohort 1: cDMARD Cohort Minimum age 18 years, first-time initiation of a conventional synthetic DMARD (administered subcutaneously or orally), outpatient follow-up visits every 3 months, confirmed diagnosis of rheumatoid arthritis or psoriatic arthritis, sufficient language skills to understand the informed consent. Cohort 2: bDMARD Cohort Minimum age 18 years, first-time initiation of a subcutaneously administered biological DMARD, outpatient follow-up visits every 3 months, confirmed diagnosis of seropositive rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis, sufficient language skills to understand the informed consent.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Therapy adherence after 6 months, measured using the Medication Adherence Report Scale – German version (MARS-D). • Assessment time point: Week 24 ± 2 • Scale: 1 to 5	—

Secondary

Measure	Time frame
1. Time spent on the physician’s counseling session. Measurement of the duration of the counseling session by the physician. 2. Use of shared decision making – Week 0. Documentation in the physician’s assessment form as a dichotomous variable (Yes/No). 3. Subjectively perceived clarity of the counseling – Week 0. Patient questionnaire; rated on a scale from 1 (“not clear at all”) to 5 (“very clear”). 4. Professional qualification of the counseling rheumatologist – Week 0. Qualitative categorization (e.g., resident physician, board-certified specialist). 5. Patient satisfaction with the counseling – Week 0. Patient questionnaire; scale from 1 (“not satisfied at all”) to 5 (“very satisfied”).	—

Measure

Time frame

1. Time spent on the physician’s counseling session. Measurement of the duration of the counseling session by the physician. 2. Use of shared decision making – Week 0. Documentation in the physician’s assessment form as a dichotomous variable (Yes/No). 3. Subjectively perceived clarity of the counseling – Week 0. Patient questionnaire; rated on a scale from 1 (“not clear at all”) to 5 (“very clear”). 4. Professional qualification of the counseling rheumatologist – Week 0. Qualitative categorization (e.g., resident physician, board-certified specialist). 5. Patient satisfaction with the counseling – Week 0. Patient questionnaire; scale from 1 (“not satisfied at all”) to 5 (“very satisfied”).

—

Countries

Germany

Contacts

Public ContactVanessa Bartsch

Klinikum Nürnberg, Abteilung Rheumatologie

rheumatologie@klinikum-nuernberg.de+ 49 911 398-3051

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026