Outpatient Follow-up on Demand in Rheumatoid Arthritis
Patient-controlled Outpatient Follow-up on Demand for Patients With Rheumatoid Arthritis: a Two-year Randomized Trial
1 other identifier
interventional
282
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedJuly 20, 2020
July 1, 2020
1.9 years
July 7, 2020
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analogue Scale (VAS) Patient satisfaction
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).
2 years
Secondary Outcomes (2)
Disease activity score in 28 joints (DAS28)
2 years
Radiographic progression
2 year
Study Arms (2)
Open outpatient clinic programme (OOCP)
ACTIVE COMPARATOROOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist, and had access to nurse-led consultations and telephone helpline.
Traditional scheduled routine follow up (TSRF)
NO INTERVENTIONAppointments for the TSRF group were scheduled according to routine procedures.
Interventions
Eligibility Criteria
You may qualify if:
- RA. Disease duration of at least 1 year.
You may not qualify if:
- Patients treated with monthly intravenous biological medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Gentofte
Hellerup, Copenhagen, 2900, Denmark
Related Publications (1)
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.
PMID: 33677724DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Annette Hansen
University Hospital Gentofte
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 20, 2020
Study Start
February 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
July 20, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share