Rheumatoid Arthritis
Conditions
Keywords
Follow-up on demand
Brief summary
A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. Patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at baseline, year 1 and 2, including assessment of disease activity and reporting of outcomes measures on a touch screen at the clinic.
Detailed description
A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. At baseline, patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at baseline, year 1 and 2, including assessment of disease activity (DAS-28), blood tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome measures. The objective of the study was to compare an outpatient system for Danish RA patients based on patient self-controlled outpatient follow up on demand, Open Outpatient Clinic Programme with traditional scheduled routine follow-up regarding patient satisfaction and effect on traditional disease markers. The Danish National Patient Registry (DANBIO) was used to identify eligible patients with RA. At pre-planned routine visits with the rheumatologist, identified patients were screened according to inclusion and exclusion criteria. The intervention group had no scheduled appointments at the outpatient clinic, but they could book acute appointments with their contact rheumatologist within 5 days or less whenever they deemed it necessary. They also had access to nurse-led consultations without pre-booked appointments and to a nurse-led telephone helpline
Interventions
OTHEROpen Outpatient Clinic Programme
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Observation of clinical outcomes in two groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
RA. Disease duration of at least 1 year.
Exclusion criteria
Patients treated with monthly intravenous biological medicine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue Scale (VAS) Patient satisfaction | 2 years | Patient reported outcome which assess overall how satisfied the patient is regarding the management of their rheumatoid arthritis in the hospital setting. Patient satisfaction is scored on a visual analogue scale (VAS). Minimum score is 0 (worst), and maximum score 100 (best). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity score in 28 joints (DAS28) | 2 years | DAS28 is a measure of disease activity in rheumatoid arthritis. To calculate the DAS28 we counted the number of swollen joints and tender joints (out of the 28), measured C reactive protein (CRP) and assessed the patients 'global assessment of health' (indicated on a visual analogue scale from 0 (best) to 100 (worst) |
| Radiographic progression | 2 year | Radiographs of hands and feet were compared between baseline and follow-up, regarding development of structural changes, including bone erosions. A musculoskeletal radiologist evaluated whether erosive development or progression was present. |
Countries
Denmark
Outcome results
None listed