Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis (SATIE-PR)
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Smartphone
physical follow up
Sponsored by
About this trial
This is an interventional diagnostic trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- UH Montpellier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
connected group
control group
Arm Description
remote monitoring by smartphone in the care management of patients with rheumatoid arthritis
standard outpatient follow-up by physical consultation
Outcomes
Primary Outcome Measures
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
Number of consultations
% of patients who benefit from at least 4 consultations over a 6-month period.
Secondary Outcome Measures
Full Information
NCT ID
NCT03005925
First Posted
December 19, 2016
Last Updated
September 1, 2023
Sponsor
University Hospital, Montpellier
Collaborators
European Union, Occitanie Region
1. Study Identification
Unique Protocol Identification Number
NCT03005925
Brief Title
Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Study Start Date
August 16, 2016 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
July 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
European Union, Occitanie Region
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
connected group
Arm Type
Experimental
Arm Description
remote monitoring by smartphone in the care management of patients with rheumatoid arthritis
Arm Title
control group
Arm Type
Active Comparator
Arm Description
standard outpatient follow-up by physical consultation
Intervention Type
Device
Intervention Name(s)
Smartphone
Other Intervention Name(s)
tele medicine follow up
Intervention Description
Smartphone application coupled with a hand dynamometer
Intervention Type
Other
Intervention Name(s)
physical follow up
Intervention Description
regular visits with the specialist
Primary Outcome Measure Information:
Title
Consultation
Description
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
Time Frame
follow up of patients over 6 months
Title
Number of consultations
Description
% of patients who benefit from at least 4 consultations over a 6-month period.
Time Frame
follow up of patients over 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33020846
Citation
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.
Results Reference
background
PubMed Identifier
35248737
Citation
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.
Results Reference
derived
Learn more about this trial
Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs