Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Smartphone
* Other: physical follow up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: connected group<br>remote monitoring by smartphone in the care management of patients with rheumatoid arthritis | Device: Smartphone<br>* Smartphone application coupled with a hand dynamometer<br>* Other names: tele medicine follow up;|
| Active Comparator: control group<br>standard outpatient follow-up by physical consultation | Other: physical follow up<br>* regular visits with the specialist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consultation | 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 | follow up of patients over 6 months | 
| Number of consultations | % of patients who benefit from at least 4 consultations over a 6-month period. | follow up of patients over 6 months |