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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: connected group
remote monitoring by smartphone in the care management of patients with rheumatoid arthritis
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
- 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
- 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.
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
|Montpellier, France, 34295|