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

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05417477
• Other study ID #: RECHMPL21_0412
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: Yves-Marie PERS, MCU-PhD
• Phone: 04.67.33.72.31
• Email: ym-pers[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Rheumatoid Arthritis

Intervention

Device:
• use of an e-health application
Use of the e-health application throughout the duration of the study combined with the usual management of the disease and 20 physiotherapy sessions.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	between baseline and 6 months
Secondary	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	between inclusion and 6 months
Secondary	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	between baseline and 6 months
Secondary	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	between baseline and 6 months
Secondary	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	between baseline and 6 months
Secondary	Percentage of adherent patients who are satisfied with the intervention	Assess the association between patient adherence and satisfaction at 6 months	between baseline and 6 months
Secondary	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	between baseline and 6 months