Clinical trial NCT04476875: Outpatient Follow-up on Demand in Rheumatoid Arthritis
Official title: Patient-controlled Outpatient Follow-up on Demand for Patients With Rheumatoid Arthritis: a Two-year Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Follow-up on demand
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Observation of clinical outcomes in two groups
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: Inclusion Criteria:

RA. Disease duration of at least 1 year.

Exclusion Criteria:

Patients treated with monthly intravenous biological medicine

Primary outcomes:
measure: Visual analogue Scale (VAS) Patient satisfaction
timeFrame: 2 years
Secondary outcomes:
measure: Disease activity score in 28 joints (DAS28)
timeFrame: 2 years
measure: Radiographic progression
timeFrame: 2 year
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: University Hospital Gentofte
state: Copenhagen
Study officials:
affiliation: University Hospital Gentofte
name: Annette Hansen
role: STUDY_CHAIR
References:
citation: Poggenborg RP, Madsen OR, Sweeney AT, Dreyer L, Bukh G, Hansen A. Patient-controlled outpatient follow-up on demand for patients with rheumatoid arthritis: a 2-year randomized controlled trial. Clin Rheumatol. 2021 Sep;40(9):3599-3604. doi: 10.1007/s10067-021-05674-y. Epub 2021 Mar 6.