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Outpatient Follow-up on Demand in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Open Outpatient Clinic Programme
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Follow-up on demand

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

RA. Disease duration of at least 1 year.

Exclusion Criteria:

Patients treated with monthly intravenous biological medicine

Sites / Locations

  • University Hospital Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Open outpatient clinic programme (OOCP)

Traditional scheduled routine follow up (TSRF)

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Disease activity score in 28 joints (DAS28)
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
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.

Full Information

First Posted
July 7, 2020
Last Updated
July 14, 2020
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04476875
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Follow-up on demand

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Observation of clinical outcomes in two groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open outpatient clinic programme (OOCP)
Arm Type
Active Comparator
Arm 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.
Arm Title
Traditional scheduled routine follow up (TSRF)
Arm Type
No Intervention
Arm Description
Appointments for the TSRF group were scheduled according to routine procedures.
Intervention Type
Other
Intervention Name(s)
Open Outpatient Clinic Programme
Primary Outcome Measure Information:
Title
Visual analogue Scale (VAS) Patient satisfaction
Description
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).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease activity score in 28 joints (DAS28)
Description
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)
Time Frame
2 years
Title
Radiographic progression
Description
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.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: RA. Disease duration of at least 1 year. Exclusion Criteria: Patients treated with monthly intravenous biological medicine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Hansen
Organizational Affiliation
University Hospital Gentofte
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Gentofte
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33677724
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. Erratum In: Clin Rheumatol. 2022 Aug;41(8):2617.
Results Reference
derived

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Outpatient Follow-up on Demand in Rheumatoid Arthritis

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