Tight Control of Disease Activity Among Patients With RA Based on a Systematic Telemedicine Treatment Strategy
TeRA
1 other identifier
interventional
300
1 country
2
Brief Summary
The study aims to investigate the effect a systematic telemedicine intervention, based on the tigth control principals, as a platform for disease monitoring among patients with rheumatoid arthritis. It is hypothesized that:
- A systematic telemedicine intervention targeted to tight control of disease activity among patients with RA will be equally effective as usual care (outpatient consultation by a rheumatologist).
- There will be no difference in the effect whether this telemedicine consultation is carried out by a rheumatologist or a rheumatology nurse.
- Patient satisfaction and the patient's general perception of involvement in their treatment will be increased for patients who receive the telemedicine intervention.
- All the effects will apply both in the short term (\< 6 months) and in the long term (\> 1 year).
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 May 2014
Shorter than P25 for not_applicable rheumatoid-arthritis
2 active sites
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
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 9, 2015
April 1, 2014
Same day
June 2, 2014
July 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Activity Score-CRP (DAS28, CRP)
RA disease activity is measured using DAS28, CRP. This score includes: tender and swollen joint count together with the patient's global assessment, report of physical functioning, the measurement of an acute-phase reactant. The DAS28 score run from 0-9.4 and RA disease activity is defined as followed: DAS28\< 3.2: mild disease activity, DAS28 \>3.2-\< 5.1: moderate disease activity, DAS28 \>5.1: high disease activity.
One year
Secondary Outcomes (2)
Self-efficacy
One year
X Ray, hand and feet
one year
Other Outcomes (3)
The Flare Instrument (FI)
weeks 13, 26, 39 and 52
Quality of life (EQ5D)
one year
Health assessment Questionnaire
Weeks 13, 26, 39, 52
Study Arms (3)
Disease control, Telemedicine, doctor
EXPERIMENTALUsing an online platform for self assessment and with the Flare instrument as decision support, the patients are contacted over the telephone by a doctor at week 13, 26, 39.
Disease control, Telemedicine, nurse
EXPERIMENTALUsing an online platform for self assessment and with the Flare instrument as decision support, the patients are contacted over the telephone by a nurse at week 13, 26, 39.
Usual care
NO INTERVENTIONUsual care: control of disease activity with consultations in the outpatient clinic.
Interventions
Control of disease activity by a telemedicine consultation carried out by a doctor. The telemedicine consultation will be based on a telephone consultation, following a predefined consultation checklist. Patients who have expressed a desire to complete questionnaires in webform, will receive a letter a week before the consultation to remind them that they must assess their disease activity through the software interphase, within the next couple of days. Patients, who have expressed a wish to fill in questionnaires in paperform, will receive the questionnaire a week before the consultation. During telephone consultation, updated clinical test results will be available through the electronic medical system.
Control of disease activity by a telemedicine consultation carried out by a nurse. The telemedicine consultation will be based on a telephone consultation, following a predefined consultation checklist. Patients who have expressed a desire to complete questionnaires in webform, will receive a letter a week before the consultation to remind them that they must assess their disease activity through the software interphase, within the next couple of days. Patients, who have expressed a wish to fill in questionnaires in paperform, will receive the questionnaire a week before the consultation. During telephone consultation, updated clinical test results will be available through the electronic medical system.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with rheumatoid arthritis according to the criteria's defined by the American College of Rheumatology, 1987, with a disease duration \>= 2 years.
You may not qualify if:
- Patients unable to answer a questionnaire.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Rheumatology, Aarhus University Hospital
Aarhus, 8000, Denmark
Department of Rheumatology, Silkeborg Regional Hospital
Silkeborg, 8600, Denmark
Related Publications (1)
de Thurah A, Stengaard-Pedersen K, Axelsen M, Fredberg U, Schougaard LMV, Hjollund NHI, Pfeiffer-Jensen M, Laurberg TB, Tarp U, Lomborg K, Maribo T. Tele-Health Followup Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):353-360. doi: 10.1002/acr.23280. Epub 2018 Jan 23.
PMID: 28511288DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annette de Thurah, MPH, Ph.D
Department of Rheumatology, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2014
First Posted
June 4, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2014
Study Completion
July 1, 2015
Last Updated
July 9, 2015
Record last verified: 2014-04