Lupuse-LUPUSNCT03953690
Acceptability and Persistence of the Use of a Patient-centred E-health Tool for Lupus Patients Followed in a Specialised Centre in France
An observational study of Lupus, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Systemic lupus erythematosus (SLE) is a complex disease whose evaluation in daily practice and clinical research requires consideration of several aspects, in particular disease activity and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus
- What is being tested?
- use of e-Health service
- How many people
- 221 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2020to 5 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients attending a consultation in their usual treatment centre
Who may be able to join
- Adult > 18 years old
- Having given oral consent for participation
- Confirmed systemic lupus diagnosis (ACR criteria)
- Regular follow-up in the centre for more than 12 months
- With Internet access at home
- Affiliated with national health insurance system or other system
Who cannot join
- Persons subject to a legal protection measure (curatorship, guardianship)
- Persons subject to limited judicial protection
- Adults who are incapable or unable to express their consent
- Patients who cannot read French
- Patients whose cognitive status does not allow them to track their health data on a digital platform
- Patients to be followed up in another centre within 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Systemic lupus erythematosus (SLE) is a complex disease whose evaluation in daily practice and clinical research requires consideration of several aspects, in particular disease activity and quality of life.
Health systems are increasingly using Patient Reported Outcome measures (PRO) data to measure different dimensions of the disease and its experience.
Read more
In addition, there is a growing number of "e-health" tools for patients. Indeed, the collection of health-related data via an electronic system makes it possible to modernise and facilitate communication between patients and doctors within the framework of medical follow-up and therapeutic education. Nevertheless, very few studies measure the acceptability and effective long-term use of such tools, particularly in the context of SLE.
The Sanoïa patient platform is a digital tool already used in therapeutic areas similar to SLE (discoid lupus erythematosus and rheumatoid arthritis), offering a guarantee of safety and a reduced individual cost.
The availability of this health-related quality of life data collection tool via a site and a mobile application adapted to patients with SLE should:
- Facilitate the collection by patients of their quality of life as part of their routine follow-up (patient access)
- Limit the impact of patients' clinical profiles on the frequency of the collection of quality of life data
- Enable internal medicine specialists to systematically use their patients' quality of life data during consultation (physician access).
This study therefore proposes to evaluate this digital platform within the framework of SLE by measuring the distribution of access by physicians according to the data reported by patients and according to the characteristics of the facilities where the subjects were recruited for the study. These data will allow us to evaluate the influence of factors extrinsic to patients on the adoption of the tool. This area has been very poorly evaluated in the few studies that have focused on the adoption of such tools.
- Conditions
- Lupus
- Being tested
- use of e-Health service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of e-Health serviceOther
use of the e-Health e-Lupus account (at least) once a month and encouraged to advise his doctor to consult the entered data before the following consultation
What is being measured
The primary outcome is the main question the study is designed to answer.
utilization rate of online patient account
rate of use of the patient account at least twice, at least 1 month apart, over a 12-month period
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start19 Mar 2020
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Why it stopped: lack of support from doctors and patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953690
- Sponsor's protocol ID
- DEVILLIERS 2018
- Acronym
- e-LUPUS
- Status last verified
- Sep 2023
- First submitted
- 15 May 2019
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Persistence of the Use of a Patient-centred E-health Tool for Lupus Patients Followed in a Specialised Centre in France
- ClinicalTrials.gov ID
- NCT03953690
- Acronym / sponsor ID
- e-LUPUS / DEVILLIERS 2018
- Conditions
- Lupus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of support from doctors and patients
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 16 May 2019 (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.
Systemic lupus erythematosus (SLE) is a complex disease whose evaluation in daily practice and clinical research requires consideration of several aspects, in particular disease activity and quality of life.
Health systems are increasingly using Patient Reported Outcome measures (PRO) data to measure different dimensions of the disease and its experience.
In addition, there is a growing number of "e-health" tools for patients. Indeed, the collection of health-related data via an electronic system makes it possible to modernise and facilitate communication between patients and doctors within the framework of medical follow-up and therapeutic education. Nevertheless, very few studies measure the acceptability and effective long-term use of such tools, particularly in the context of SLE.
The Sanoïa patient platform is a digital tool already used in therapeutic areas similar to SLE (discoid lupus erythematosus and rheumatoid arthritis), offering a guarantee of safety and a reduced individual cost.
The availability of this health-related quality of life data collection tool via a site and a mobile application adapted to patients with SLE should:
- Facilitate the collection by patients of their quality of life as part of their routine follow-up (patient access)
- Limit the impact of patients' clinical profiles on the frequency of the collection of quality of life data
- Enable internal medicine specialists to systematically use their patients' quality of life data during consultation (physician access).
This study therefore proposes to evaluate this digital platform within the framework of SLE by measuring the distribution of access by physicians according to the data reported by patients and according to the characteristics of the facilities where the subjects were recruited for the study. These data will allow us to evaluate the influence of factors extrinsic to patients on the adoption of the tool. This area has been very poorly evaluated in the few studies that have focused on the adoption of such tools.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients attending a consultation in their usual treatment centre
Key inclusion criteria (6 listed)
- Adult > 18 years old
- Having given oral consent for participation
- Confirmed systemic lupus diagnosis (ACR criteria)
- Regular follow-up in the centre for more than 12 months
- With Internet access at home
Key exclusion criteria (6 listed)
- Persons subject to a legal protection measure (curatorship, guardianship)
- Persons subject to limited judicial protection
- Adults who are incapable or unable to express their consent
- Patients who cannot read French
- Patients whose cognitive status does not allow them to track their health data on a digital platform
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 e-Health serviceuse of the e-Health e-Lupus account (at least) once a month and encouraged to advise his doctor to consult the entered data before the following consultation | Other | – |
Primary outcome
utilization rate of online patient account
Time frame: Through study completion, an average of 24 months
rate of use of the patient account at least twice, at least 1 month apart, over a 12-month period
Results and safety
The study was stopped early (reason given: lack of support from doctors and patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Oct 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?
The study was stopped early (reason given: lack of support from doctors and patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
utilization rate of online patient account (time frame: Through study completion, an average of 24 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 2 Oct 2023.