Rheumatoid Arthritis Clinical Trial
— TeRAOfficial title:
Tight Control of Disease Activity Among Patients With Rheumatoid Arthritis Based on a Systematic Telemedicine Treatment Strategy
Verified date | April 2014 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 300 |
Est. completion date | July 2015 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with rheumatoid arthritis according to the criteria's defined by the American College of Rheumatology, 1987, with a disease duration >= 2 years. Exclusion Criteria: - Patients unable to answer a questionnaire. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Rheumatology, Aarhus University Hospital | Aarhus | |
Denmark | Department of Rheumatology, Silkeborg Regional Hospital | Silkeborg |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The Flare Instrument (FI) | A 12 item questionnaire where patients are asked to express their degree of agreement about different statements concerning disease activity on a 10-point likert scale. Six items concerns joint symptoms (tenderness, stiffness and pain) and six items is concerning general symptoms. When scoring FI it is possible to compute a FI total score (all 12 items) or a subscale for joint or general symptoms, respectively. | weeks 13, 26, 39 and 52 | No |
Other | Quality of life (EQ5D) | EQ5D consists of a questionnaire and a VAS and is designed to measure well-being as well as illness | one year | No |
Other | Health assessment Questionnaire | Measures level of function among patients with arthritis | Weeks 13, 26, 39, 52 | No |
Primary | 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 | No |
Secondary | Self-efficacy | Measured by the Generalized Self-Efficacy Scale (GSE), a 10-item scale with a score for each question ranging from 1 to 4. Higher scores indicate stronger patient's belief in self-efficacy. The GSE is designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one's actions are responsible for successful outcomes. |
One year | No |
Secondary | X Ray, hand and feet | Erosive changes | one year | No |
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