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Evaluation of a Connected Interface to Improve the Quality of Life and the Disability of Patient With Rheumatic Diseases (RHUMATO-APP)

Primary Purpose

Rheumatoid Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
use of an e-health application
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Rheumatic and musculoskeletal diseases, e-health, care pathway

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18 to 70 years
  • Presence of a chronic inflammatory rheumatism (rheumatoid arthritis, axial and/or peripheral spondyloarthritis) or osteoarthritis disease requiring the initiation of at least 20 sessions of physical therapy
  • Diagnostic confirmation left to the discretion of the investigating physician
  • Accessibility of an internet network (compatible with smartphone and/or computer)
  • Information and consent of the patient

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patient refusing or unable to give consent: patient under guardianship or curator, mentally retarded, dementia, language barrier
  • Patient not affiliated to a social security scheme
  • Patient under legal protection

Sites / Locations

  • Centre Hospitalier Universitaire de Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chronic inflammatory rheumatism or osteoarthritis

Arm Description

The experimental intervention consists in providing the patient with access to a specific version of the application ''MedicApp'' for the duration of the study. The intervention will be limited for each patient to the entry of their data on the application at regular intervals during the study. The interface on the rheumatologist side will contain the demographic characteristics of the patient, his history, the treatments and the pathology requiring the use of physiotherapy Then, at regular intervals, the scores of the questionnaires addressed to the patient will be available on his interface. The interface, on the physiotherapist side, will contain the summary of the patient's clinical history, his treatments and the reason for the physiotherapy sessions. Then, at regular intervals, the physiotherapist will indicate the patient's locomotor assessment, the type of intervention performed and the final summary.

Outcomes

Primary Outcome Measures

Change of the quality of life of patients between baseline and 6 months
Evaluate the impact of the computer interface on the patient's quality of life by comparing the evolution of the global SF-12 score between baseline and 6 months (longitudinal follow-up). The Survey Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is a shortened version of SF-36. The SF-12 have eight domains : Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions

Secondary Outcome Measures

Percentage of satisfied patients
To assess the patient's satisfaction with the use of this device at the end of the 6-month follow-up with the F-SUS (French System Usability Scale) questionnaire. The F-SUS (French System Usability Scale) is a 10-items, to determine the level of satisfaction of users of a service and the usability of the interactive system of the study. Score range from 1 to 5 with 1=totally disagree and 5=totally agree
Percentage of patients adhering to the interface
Evaluate the patient's adherence to the use of a computer interface based on the weekly filling rate during the 6-month follow-up
Percentage of adherent patients whose disease activity is positively impacted
Assess the association between patient adherence and change in disease activity level between baseline and 6 months
Percentage of adherent patients whose quality of life is positively impacted
Evaluate the association between patient compliance and the variation in their quality of life between baseline and 6 months
Percentage of adherent patients who are satisfied with the intervention
Assess the association between patient adherence and satisfaction at 6 months
Percentage of satisfied caregivers
Assess the satisfaction of caregivers (physiotherapist, rheumatologist) with the use of this device at the end of the 6-month follow-up

Full Information

First Posted
May 27, 2022
Last Updated
September 7, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05417477
Brief Title
Evaluation of a Connected Interface to Improve the Quality of Life and the Disability of Patient With Rheumatic Diseases
Acronym
RHUMATO-APP
Official Title
Evaluation of a Connected Interface (Rheumatologist, Physiotherapist, Patient) to Improve the Quality of Life and the Disability of Patients With Rheumatic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Musculoskeletal pathologies constitute a major public health problem. Rheumatologists, whether they practice in private or hospital settings, play a major role in the management of responsible for these ailments. Due to the increase in life expectancy, an increase in the number of consultations can be expected. It is therefore imperative that the latter be more efficient, without losing quality. Communication between doctor and patient is bound to evolve due to the multiplicity of IT tools available and those that are emerging, which are increasingly essential, including many smartphone applications. Each targeting a specific pathology (rheumatoid arthritis, ankylosing spondylitis, osteoporosis osteoarthritis, they will allow the patient to self-assess, thus becoming an actor in his own care. A "facilitated" exchange between caregivers and patients would be relevant and would provide added value for all. This is the reason why there is a real need for an application listing precise information on the patient, in a sufficiently succinct way to optimize their transmission to the physiotherapist.
Detailed Description
Musculoskeletal pathologies constitute a major public health problem. Rheumatologists, whether they practice in private or hospital settings, play a major role in the management of responsible for these ailments. Due to the increase in life expectancy, an increase in the number of consultations can be expected. It is therefore imperative that the latter be more efficient, without losing quality. Communication between doctor and patient is bound to evolve due to the multiplicity of IT tools available and those that are emerging, which are increasingly essential, including many smartphone applications. Each targeting a specific pathology (rheumatoid arthritis, ankylosing spondylitis, osteoporosis osteoarthritis, they will allow the patient to self-assess, thus becoming an actor in his own care. A "facilitated" exchange between caregivers and patients would be relevant and would provide added value for all. This is the reason why there is a real need for an application listing precise information on the patient, in a sufficiently succinct way to optimize their transmission to the physiotherapist. Our team has recently highlighted that monitoring rheumatoid arthritis in connected mode (smartphone + online interface for the physician + distancing interaction patient / caregiver) provided a benefit in terms of quality of life as well as on the medico-economics level compared to conventional monitoring, without affecting the control of rheumatoid arthritis activity. Telemedicine is positioned more than ever as an essential instrument for organizing the longitudinal monitoring of diseases, especially in a context of confinement, which implies limited access to physiotherapy sessions, even though these are essential for optimizing the management of many osteoarticular disorders. By promoting the use of a digital telemedicine tool in the follow-up of patients suffering from rheumatological pathologies in both private practice and hospitals, the Rhumato-App project aims to develop an ergonomic offline/online platform for patients/healthcare providers (e.g. rheumatologist, general practitioner, physiotherapist), accessible from a computer or a smartphone. This platform will improve the articulation of the patient's care pathway by feeding a secure medical file shared between caregivers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatic and musculoskeletal diseases, e-health, care pathway

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective exploratory pilot study. We plan to recruit 40 patients with Chronic Inflammatory Rheumatism (CIR) and 40 patients with Osteoarthritis (OA) by several investigating teams, for a total of 80 patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chronic inflammatory rheumatism or osteoarthritis
Arm Type
Experimental
Arm Description
The experimental intervention consists in providing the patient with access to a specific version of the application ''MedicApp'' for the duration of the study. The intervention will be limited for each patient to the entry of their data on the application at regular intervals during the study. The interface on the rheumatologist side will contain the demographic characteristics of the patient, his history, the treatments and the pathology requiring the use of physiotherapy Then, at regular intervals, the scores of the questionnaires addressed to the patient will be available on his interface. The interface, on the physiotherapist side, will contain the summary of the patient's clinical history, his treatments and the reason for the physiotherapy sessions. Then, at regular intervals, the physiotherapist will indicate the patient's locomotor assessment, the type of intervention performed and the final summary.
Intervention Type
Device
Intervention Name(s)
use of an e-health application
Intervention Description
Use of the e-health application throughout the duration of the study combined with the usual management of the disease and 20 physiotherapy sessions.
Primary Outcome Measure Information:
Title
Change of the quality of life of patients between baseline and 6 months
Description
Evaluate the impact of the computer interface on the patient's quality of life by comparing the evolution of the global SF-12 score between baseline and 6 months (longitudinal follow-up). The Survey Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is a shortened version of SF-36. The SF-12 have eight domains : Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions
Time Frame
between baseline and 6 months
Secondary Outcome Measure Information:
Title
Percentage of satisfied patients
Description
To assess the patient's satisfaction with the use of this device at the end of the 6-month follow-up with the F-SUS (French System Usability Scale) questionnaire. The F-SUS (French System Usability Scale) is a 10-items, to determine the level of satisfaction of users of a service and the usability of the interactive system of the study. Score range from 1 to 5 with 1=totally disagree and 5=totally agree
Time Frame
between inclusion and 6 months
Title
Percentage of patients adhering to the interface
Description
Evaluate the patient's adherence to the use of a computer interface based on the weekly filling rate during the 6-month follow-up
Time Frame
between baseline and 6 months
Title
Percentage of adherent patients whose disease activity is positively impacted
Description
Assess the association between patient adherence and change in disease activity level between baseline and 6 months
Time Frame
between baseline and 6 months
Title
Percentage of adherent patients whose quality of life is positively impacted
Description
Evaluate the association between patient compliance and the variation in their quality of life between baseline and 6 months
Time Frame
between baseline and 6 months
Title
Percentage of adherent patients who are satisfied with the intervention
Description
Assess the association between patient adherence and satisfaction at 6 months
Time Frame
between baseline and 6 months
Title
Percentage of satisfied caregivers
Description
Assess the satisfaction of caregivers (physiotherapist, rheumatologist) with the use of this device at the end of the 6-month follow-up
Time Frame
between baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 to 70 years Presence of a chronic inflammatory rheumatism (rheumatoid arthritis, axial and/or peripheral spondyloarthritis) or osteoarthritis disease requiring the initiation of at least 20 sessions of physical therapy Diagnostic confirmation left to the discretion of the investigating physician Accessibility of an internet network (compatible with smartphone and/or computer) Information and consent of the patient Exclusion Criteria: Pregnant or breastfeeding women Patient refusing or unable to give consent: patient under guardianship or curator, mentally retarded, dementia, language barrier Patient not affiliated to a social security scheme Patient under legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves-Marie PERS, MCU-PhD
Phone
04.67.33.72.31
Ext
33
Email
ym-pers@chu-montpellier.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves-Marie PERS, MCU-PhD
Phone
04.67.33.72.31
Ext
33
Email
ym-pers@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of a Connected Interface to Improve the Quality of Life and the Disability of Patient With Rheumatic Diseases

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