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

Rheumatoid Arthritis Clinical Trial

— SATIE-PR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03005925
• Other study ID #: 9726
• Status: Terminated
• Phase: N/A
• Start date: August 16, 2016
• Est. completion date: July 29, 2019

Study information

• Verified date: April 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: July 29, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Smartphone
Smartphone application coupled with a hand dynamometer

Other:
• physical follow up
regular visits with the specialist

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	European Union, Occitanie Region

Country where clinical trial is conducted

France, 

References & Publications (1)

Pers YM, Valsecchi V, Mura T, Aouinti S, Filippi N, Marouen S, Letaief H, Le Blay P, Autuori M, Fournet D, Mercier G, Ferreira R, Jorgensen C. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis. Rheumatology (Oxford). 2021 Apr 6;60(4):1659-1668. doi: 10.1093/rheumatology/keaa462. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of consultations	% of patients who benefit from at least 4 consultations over a 6-month period.	follow up of patients over 6 months