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

University Hospital Center (CHU)

Status: Terminated

Conditions: Rheumatoid Arthritis

Treatments: Other: physical follow up; Device: Smartphone

Study type: Interventional

Funder types: Other

Identifiers

NCT03005925

9726

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

connected group

Experimental group

Description:

remote monitoring by smartphone in the care management of patients with rheumatoid arthritis

Treatment:

Device: Smartphone

control group

Active Comparator group

Description:

standard outpatient follow-up by physical consultation

Treatment:

Other: physical follow up