Outpatient Follow-up on Demand in Rheumatoid Arthritis

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04476875
• Collaborator: (none)
• Enrollment: 282
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 12.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Other: Open Outpatient Clinic Programme	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 282 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Observation of clinical outcomes in two groupsObservation of clinical outcomes in two groups
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Patient-controlled Outpatient Follow-up on Demand for Patients With Rheumatoid Arthritis: a Two-year Randomized Trial
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open outpatient clinic programme (OOCP) OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist, and had access to nurse-led consultations and telephone helpline.	Other: Open Outpatient Clinic Programme
No Intervention: Traditional scheduled routine follow up (TSRF) Appointments for the TSRF group were scheduled according to routine procedures.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

RA. Disease duration of at least 1 year.

Exclusion Criteria:

Patients treated with monthly intravenous biological medicine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Gentofte	Hellerup	Copenhagen	Denmark	2900

Sponsors and Collaborators

• University Hospital, Gentofte, Copenhagen

Investigators

• Study Chair: Annette Hansen, University Hospital Gentofte

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: René Panduro Poggenborg, Principal Investigator, University Hospital, Gentofte, Copenhagen
• ClinicalTrials.gov Identifier: NCT04476875
• Other Study ID Numbers: Protokol-38787-v1-08072013
• First Posted: Jul 20, 2020
• Last Update Posted: Jul 20, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by René Panduro Poggenborg, Principal Investigator, University Hospital, Gentofte, Copenhagen: Follow-up on demand
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Jul 20, 2020