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Trial record 21 of 1220 for:    arthritis+management

Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis (SATIE-PR)

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ClinicalTrials.gov Identifier: NCT03005925
Recruitment Status : Not yet recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. It is a real public health issue. International guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the functional impact of the disease in the long term and to improve the quality of life of the patients.

This care is based on a close follow-up requiring regular visits with the specialist which represents an additional cost (transport, visits). In this context, tele-medicine is often proposed as a complementary approach in the management of these chronic patients.

Thus, the investigators propose to study the interest of a connected device by comparing a group of patients using this Smartphone application, coupled with a hand dynamometer during the 6 months following initiation of a new DMARD.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: Smartphone Other: physical follow up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open Prospective Randomized Controlled Study Comparing the Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis Versus a Standard Outpatient Follow-up by Physical Consultation
Study Start Date : February 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: connected group
remote monitoring by smartphone in the care management of patients with rheumatoid arthritis
Device: Smartphone
Smartphone application coupled with a hand dynamometer
Other Name: tele medicine follow up

Active Comparator: control group
standard outpatient follow-up by physical consultation
Other: physical follow up
regular visits with the specialist




Primary Outcome Measures :
  1. Consultation [ Time Frame: follow up of patients over 6 months ]
    To evaluate whether the use of a computerized monitoring interface on Smartphone ( "SATIE-PR" application) reduces the number of consultations during follow-up of patients with RA over 6 months

  2. Number of consultations [ Time Frame: follow up of patients over 6 months ]
    % of patients who benefit from at least 4 consultations over a 6-month period.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patients between 18 and 75 years old with rheumatoid arthritis according to 2010 ACR (American College of Rheumatology) / EULAR Classification Criteria

    • Patients that need a treatment initiation for rheumatoid arthritis
    • Patients with DAS 28 > 3.2 (Disease Activity Score )
    • Patients who agreed to participate in this study and provide the informed consent

Exclusion Criteria:

  • • Insufficient level of understanding to perform the measurement and self-report questionnaires

    • Patients without an internet connection
    • Difficulties in using a dynamometer due to a dominant-hand surgery done during the previous 12 months, carpal tunnel symptoms, or ulnar nerve compression, or cervicobrachial neuralgia, known presence of motor dysfunction of the upper extremity, or neurological disease
    • Pregnancy

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): NCT03005925


Locations
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France
UH Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03005925     History of Changes
Other Study ID Numbers: 9726
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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