Rheumatoid ArthritisRHUMATO-APPNCT05417477
Evaluation of a Connected Interface to Improve the Quality of Life and the Disability of Patient With Rheumatic Diseases
A study testing use of an e-health application in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- use of an e-health application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Yves-Marie PERS, MCU-PhD, 04.67.33.72.31 ext. 33, ym-pers@chu-montpellier.fr
About this study
Official title: Evaluation of a Connected Interface (Rheumatologist, Physiotherapist, Patient) to Improve the Quality of Life and the Disability of Patients With Rheumatic Diseases
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.
Read more
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 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- use of an e-health application
- Keywords
- Rheumatic and musculoskeletal diseases, e-health, care pathway
- Medical subject headings
- Arthritis, Rheumatoid, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of an e-health applicationDevice
Use of the e-health application throughout the duration of the study combined with the usual management of the disease and 20 physiotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| chronic inflammatory rheumatism or osteoarthritis | Experimental | 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. Receives: Device: use of an e-health application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between baseline and 6 months
Secondary outcomes (6)
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
Measured: between inclusion and 6 months
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
Measured: between baseline and 6 months
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
Measured: 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
Measured: 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
Measured: between baseline and 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
Measured: between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Oct 2023 (estimated)
- Primary completion22 Dec 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417477
- Sponsor's protocol ID
- RECHMPL21_0412
- Acronym
- RHUMATO-APP
- Status last verified
- Sep 2023
- First submitted
- 27 May 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Connected Interface (Rheumatologist, Physiotherapist, Patient) to Improve the Quality of Life and the Disability of Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT05417477
- Acronym / sponsor ID
- RHUMATO-APP / RECHMPL21_0412
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatic and musculoskeletal diseases, e-health, care pathway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| chronic inflammatory rheumatism or osteoarthritis | Experimental | Device: use of an e-health applicationThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of an e-health applicationUse of the e-health application throughout the duration of the study combined with the usual management of the disease and 20 physiotherapy sessions. | Device | chronic inflammatory rheumatism or osteoarthritis |
Primary outcome
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
6 secondary outcomes
Percentage of satisfied patients
Time frame: between inclusion and 6 months
Percentage of patients adhering to the interface
Time frame: between baseline and 6 months
Percentage of adherent patients whose disease activity is positively impacted
Time frame: between baseline and 6 months
Percentage of adherent patients whose quality of life is positively impacted
Time frame: between baseline and 6 months
Percentage of adherent patients who are satisfied with the intervention
Time frame: between baseline and 6 months
Percentage of satisfied caregivers
Time frame: between baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of an e-health application in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves-Marie PERS, MCU-PhD (04.67.33.72.31 ext. 33, ym-pers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the quality of life of patients between baseline and 6 months (time frame: between baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.