Skip to content

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

Evaluation of a Connected Interface (Rheumatologist, Physiotherapist, Patient) to Improve the Quality of Life and the Disability of Patients With Rheumatic Diseases

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05417477
Acronym
RHUMATO-APP
Enrollment
80
Registered
2022-06-14
Start date
2023-10-01
Completion date
2023-12-22
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatic and musculoskeletal diseases, e-health, care pathway

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.

Interventions

DEVICEuse 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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the quality of life of patients between baseline and 6 monthsbetween baseline and 6 monthsEvaluate 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 : 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions

Secondary

MeasureTime frameDescription
Percentage of patients adhering to the interfacebetween baseline and 6 monthsEvaluate 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 impactedbetween baseline and 6 monthsAssess the association between patient adherence and change in disease activity level between baseline and 6 months
Percentage of satisfied patientsbetween inclusion and 6 monthsTo 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 adherent patients who are satisfied with the interventionbetween baseline and 6 monthsAssess the association between patient adherence and satisfaction at 6 months
Percentage of satisfied caregiversbetween baseline and 6 monthsAssess the satisfaction of caregivers (physiotherapist, rheumatologist) with the use of this device at the end of the 6-month follow-up
Percentage of adherent patients whose quality of life is positively impactedbetween baseline and 6 monthsEvaluate the association between patient compliance and the variation in their quality of life between baseline and 6 months

Countries

France

Contacts

Primary ContactYves-Marie PERS, MCU-PhD
ym-pers@chu-montpellier.fr04.67.33.72.31

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026