Outpatient Follow-up on Demand in Rheumatoid Arthritis

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Open Outpatient Clinic Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT04476875

Protokol-38787-v1-08072013

Details and patient eligibility

About

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.

Full 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

Enrollment: 282 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

RA. Disease duration of at least 1 year.

Exclusion criteria

Patients treated with monthly intravenous biological medicine

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Open outpatient clinic programme (OOCP)

Active Comparator group

Description:

OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist, and had access to nurse-led consultations and telephone helpline.

Treatment:

Other: Open Outpatient Clinic Programme

Traditional scheduled routine follow up (TSRF)

No Intervention group

Description:

Appointments for the TSRF group were scheduled according to routine procedures.