Covid19SePaRICNCT04806867
Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia
An observational study of Covid19 and Inflammatory Rheumatism, run by University Hospital, Limoges at 1 site in France.
Trial summary
The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Inflammatory Rheumatism, Rheumatoid Arthritis
- What is being tested?
- SePaRIC-Covid19 cohort
- How many people
- 918 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 31 Jul 2020
- 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 with chronic inflammatory rheumatism
Who may be able to join
- Patients with chronic inflammatory rheumatism who answered the RIC-COVID19 survey during the telephone call set up by the Rheumatology Department of the Limoges University Hospital during the confinement.
Who cannot join
- Patients objecting to the use of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy
The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk
Read the detailed description
The COVID-19 pandemic led to the suspension of consultations and hospitalization of the majority of patients followed in the Rheumatology Department of the Limoges University Hospital.
The department therefore implemented a strategy for the management of patients with chronic inflammatory rheumatism (CIR) during this period, which allowed maintaining contact with patients in the patient database.
During this telephone call, an CIR-Covid19 questionnaire was fulfilled in order to prioritize patients requiring rapid management.
The strategy is based on the use of the available health reserve, i.e. volunteered medical students to provide patient management assistance. These students were trained with face-to-face learning in the rheumatology department given by residents on chronic inflammatory rheumatism to remind them of all the elements of diagnosis and management. They had an interview with a senior rheumatologist from the Department to present the questionnaire and its objectives , to give them advice regarding communication with patients, as well as information about the COVID-19 infection and recommendations of the French Rheumatology Society for CIR patients. The students were trained with quizzes on practical situations, with feedback on the answers.
The information's collected in the questionnaire were based on the patients' feelings. Telephone communication does not allow an assessment of disease activity according to validated criteria as it requires a clinical examination.
The opinion of the referring rheumatologist was requested by the patients or by the medical student at the end of the telephone call, depending on the information collected. At any time, the medical students could call upon to senior doctors from the department or residents in case of difficulties.
943 patients were thus contacted between 14/04/2020 and 28/04/2020. They were able to benefit from an optimized management according to the context of the COVID19 pandemic.
These questionnaires were analyze in order to assess the need for specialized follow-up during this period and to evaluate the impact of COVID19 on this population.
- Conditions
- Covid19, Inflammatory Rheumatism, Rheumatoid Arthritis, Spondyloarthritis, Inflammatory Arthritis
- Being tested
- SePaRIC-Covid19 cohort
- Keywords
- Chronic Inflammatory Rheumatism - COVID-19
- Medical subject headings
- COVID-19, Rheumatic Fever, Arthritis, Rheumatoid, Spondylarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SePaRIC-Covid19 cohortOther
All patients with Chronic Inflammatory Rheumatism who were contacted by telephone as part of the innovative organizational strategy and who did not object to the use of their data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Number of request for advice from the referring Rheumatologist by the student and/or the patient
Measured: 2 months
Secondary outcomes (8)
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Request for an advice from the referring rheumatologist by the student and/or the patient and the factors studied.
Factors studied:
Sex, age, department of residence, RA or AS COVID-19 symptoms, increase in CIR activity, increase in pain, discontinuation of treatment, increase in stress and anxiety, increase in depression, increase in fatigue, increase in sleep disorders, fear of coming to consultation or hospitalization, adaptability with their rheumatic disease, medical loneliness.
Measured: 2 months
COVID-19 infection evaluation in the monitored patient population
Evaluate the proportion of COVID-19 infection in patients monitored in the Rheumatology department at Limoges University Hospital Proportion of COVID-19 serological tests performed and their positivity in this patient population.
Measured: 2 months
Proportion of patients informed about COVID-19
Evaluate the proportion of patients having received medical information about the Covid-19 pandemic.
Measured: 2 months
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied using numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
Measured: 2 months
Evaluate the association between pain increase perceived by patients and the factors studied
Percentage increase in pain perceived by patients during the epidemic and factors studied, evaluated by numerical scale during the phone call 0% to 100% (0% represente no pain, and 100% maximal pain)
Measured: 2 months
Evaluate the association between rheumatologist advice asked by student and the factors studied
request for an advice from the referring rheumatologist by the student and the factors studied
Measured: 2 months
Evaluate the association between rheumatologist advice asked by patient and the factors studied
request for an advice from the referring rheumatologist by the patient and the factors studied.
Measured: 2 months
To evaluate the satisfaction of the telephone call with patients and students. Time Frame: phone call day
Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 May 2020
- Primary completion1 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Retrospective
- Enrolment
- 918 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale PV Vergne-Salle, MD-PhD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806867
- Sponsor's protocol ID
- 87RI20_0044 (SePaRIC)
- Acronym
- SePaRIC
- Status last verified
- Mar 2021
- First submitted
- 9 Dec 2020
- Last updated
- 1 Apr 2021
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy
- ClinicalTrials.gov ID
- NCT04806867
- Acronym / sponsor ID
- SePaRIC / 87RI20_0044 (SePaRIC)
- Conditions
- Covid19, Inflammatory Rheumatism, Rheumatoid Arthritis, Spondyloarthritis, Inflammatory Arthritis
- Keywords
- Chronic Inflammatory Rheumatism - COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 918 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 19 Mar 2021 (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.
The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk
Detailed description
The COVID-19 pandemic led to the suspension of consultations and hospitalization of the majority of patients followed in the Rheumatology Department of the Limoges University Hospital.
The department therefore implemented a strategy for the management of patients with chronic inflammatory rheumatism (CIR) during this period, which allowed maintaining contact with patients in the patient database.
During this telephone call, an CIR-Covid19 questionnaire was fulfilled in order to prioritize patients requiring rapid management.
The strategy is based on the use of the available health reserve, i.e. volunteered medical students to provide patient management assistance. These students were trained with face-to-face learning in the rheumatology department given by residents on chronic inflammatory rheumatism to remind them of all the elements of diagnosis and management. They had an interview with a senior rheumatologist from the Department to present the questionnaire and its objectives , to give them advice regarding communication with patients, as well as information about the COVID-19 infection and recommendations of the French Rheumatology Society for CIR patients. The students were trained with quizzes on practical situations, with feedback on the answers.
The information's collected in the questionnaire were based on the patients' feelings. Telephone communication does not allow an assessment of disease activity according to validated criteria as it requires a clinical examination.
The opinion of the referring rheumatologist was requested by the patients or by the medical student at the end of the telephone call, depending on the information collected. At any time, the medical students could call upon to senior doctors from the department or residents in case of difficulties.
943 patients were thus contacted between 14/04/2020 and 28/04/2020. They were able to benefit from an optimized management according to the context of the COVID19 pandemic.
These questionnaires were analyze in order to assess the need for specialized follow-up during this period and to evaluate the impact of COVID19 on this population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic inflammatory rheumatism
Key inclusion criteria (1 listed)
- Patients with chronic inflammatory rheumatism who answered the RIC-COVID19 survey during the telephone call set up by the Rheumatology Department of the Limoges University Hospital during the confinement.
Key exclusion criteria (1 listed)
- Patients objecting to the use of their data
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 |
|---|---|---|
| SePaRIC-Covid19 cohortAll patients with Chronic Inflammatory Rheumatism who were contacted by telephone as part of the innovative organizational strategy and who did not object to the use of their data. | Other | – |
Primary outcome
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Time frame: 2 months
Number of request for advice from the referring Rheumatologist by the student and/or the patient
8 secondary outcomes
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Time frame: 2 months
COVID-19 infection evaluation in the monitored patient population
Time frame: 2 months
Proportion of patients informed about COVID-19
Time frame: 2 months
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied
Time frame: 2 months
Evaluate the association between pain increase perceived by patients and the factors studied
Time frame: 2 months
Evaluate the association between rheumatologist advice asked by student and the factors studied
Time frame: 2 months
Evaluate the association between rheumatologist advice asked by patient and the factors studied
Time frame: 2 months
To evaluate the satisfaction of the telephone call with patients and students. Time Frame: phone call day
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
Pascale PV Vergne-Salle, MD-PhD principal investigator
University Hospital, Limoges
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 Covid19 and Inflammatory Rheumatism, run by University Hospital, Limoges 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Apr 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey. (time frame: 2 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 1 Apr 2021.