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

NCT03005925 | Terminated

• 1 other identifier: RECHMPL_0174
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

connected group

EXPERIMENTAL

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

Device: Smartphone

control group

ACTIVE COMPARATOR

standard outpatient follow-up by physical consultation

Other: physical follow up

Interventions

Smartphone DEVICE

Smartphone application coupled with a hand dynamometer

Also known as: tele medicine follow up

connected group

physical follow up OTHER

regular visits with the specialist

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• European Union: collaborator
• Occitanie Region: collaborator

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

Related Publications (2)

• 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.

  PMID: 33020846 BACKGROUND

• Bernard L, Valsecchi V, Mura T, Aouinti S, Padern G, Ferreira R, Pastor J, Jorgensen C, Mercier G, Pers YM. Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial. Joint Bone Spine. 2022 Oct;89(5):105368. doi: 10.1016/j.jbspin.2022.105368. Epub 2022 Mar 4.

  PMID: 35248737 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 30, 2016
• Study Start: August 16, 2016
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)