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

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Other: physical follow up; Device: Smartphone

• Registration Number: NCT03005925
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-16
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-30
• Primary Completion: 2019-07-29
• Study Completion: 2019-07-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	physical follow up	standard outpatient follow-up by physical consultation
connected group	Smartphone	remote monitoring by smartphone in the care management of patients with rheumatoid arthritis

Primary Outcome Measures

Name	Time	Method
Number of consultations	follow up of patients over 6 months	% of patients who benefit from at least 4 consultations over a 6-month period.
Consultation	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

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France