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TerminatedNCT05417477ClinicalTrials.gov record

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

Rheumatoid Arthritis

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 70 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
29 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

Why the study stopped

Problems encountered with the device used in the study

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
chronic inflammatory rheumatism or osteoarthritis

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.

Device: use of an e-health application

use of an e-health application DEVICE

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Change of the quality of life of patients between baseline and 6 months

Time frame: 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 :

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 measures

Percentage of satisfied patients

Time frame: between inclusion and 6 months

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

Time frame: between baseline and 6 months

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

Time frame: between baseline and 6 months

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

Time frame: between baseline and 6 months

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

Time frame: between baseline and 6 months

Assess the association between patient adherence and satisfaction at 6 months

Percentage of satisfied caregivers

Time frame: between baseline and 6 months

Assess the satisfaction of caregivers (physiotherapist, rheumatologist) with the use of this device at the end of the 6-month follow-up

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Centre Hospitalier Universitaire de MontpellierMontpellier, France, FranceStatus unknown

Study team and timeline

Lead sponsor
University Hospital, Montpellier
Study start
May 23, 2024 Actual
Primary completion
Mar 31, 2025 Actual
Study completion
Mar 31, 2025 Actual
First posted
Jun 14, 2022 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026