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Trial record 45 of 244370 for:    Diseases

Tight Control of Disease Activity Among Patients With RA Based on a Systematic Telemedicine Treatment Strategy (TeRA)

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ClinicalTrials.gov Identifier: NCT02155894
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Disease control, Telemedicine, doctor Behavioral: Disease control, Telemedicine, nurse Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Tight Control of Disease Activity Among Patients With Rheumatoid Arthritis Based on a Systematic Telemedicine Treatment Strategy
Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Disease control, Telemedicine, doctor
Using 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.
Behavioral: Disease control, Telemedicine, doctor

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.


Experimental: Disease control, Telemedicine, nurse
Using 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.
Behavioral: Disease control, Telemedicine, nurse

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.


No Intervention: Usual care
Usual care: control of disease activity with consultations in the outpatient clinic.



Primary Outcome Measures :
  1. Disease Activity Score-CRP (DAS28, CRP) [ Time Frame: One year ]
    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.


Secondary Outcome Measures :
  1. Self-efficacy [ Time Frame: One year ]

    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.


  2. X Ray, hand and feet [ Time Frame: one year ]
    Erosive changes


Other Outcome Measures:
  1. The Flare Instrument (FI) [ Time Frame: weeks 13, 26, 39 and 52 ]
    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.

  2. Quality of life (EQ5D) [ Time Frame: one year ]
    EQ5D consists of a questionnaire and a VAS and is designed to measure well-being as well as illness

  3. Health assessment Questionnaire [ Time Frame: Weeks 13, 26, 39, 52 ]
    Measures level of function among patients with arthritis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155894


Locations
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Denmark
Department of Rheumatology, Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Rheumatology, Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Annette de Thurah, MPH, Ph.D Department of Rheumatology, Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02155894     History of Changes
Other Study ID Numbers: TeRA_15-05-14
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: April 2014

Keywords provided by University of Aarhus:
Rheumatoid arthritis, treat to target, telemedicine

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases