Sars-CoV2PRPsyCOVIDNCT04351399
Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
An observational study of Sars-CoV2 and Rheumatic Diseases, run by University Hospital, Lille at 1 site in France.
Trial summary
Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration. In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2, Rheumatic Diseases, Rheumatoid Arthritis
- What is being tested?
- questionnaire assesment
- How many people
- 318 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 4 May 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: RA patient will be interviewed par internet questionnaire (patient association / ANDAR)
Who may be able to join
- Rheumatoid arthritis Quarantine
Who cannot join
- Non adult patient RA patient without quarantine
Trial locations and contacts
1 site in 1 country.
About this study
Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration.
In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression.
Read more
During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients.
The present study is an "emergency" being realize before the end of the quarantine.
- Conditions
- Sars-CoV2, Rheumatic Diseases, Rheumatoid Arthritis, Chronic Pain
- Being tested
- questionnaire assesment
- Keywords
- Psychological impact, COVID-19, Rheumatoid arthritis
- Medical subject headings
- Rheumatic Diseases, Arthritis, Rheumatoid, Chronic Pain, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire assesmentOther
The questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine
| Study group | Role | What they receive |
|---|---|---|
| patient with chronic painful inflammatory rheumatism | Not described Receives: Other: questionnaire assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of RA patients with emotional impact (feeling of isolation)
Measured: maximum 1 week from baseline on
Secondary outcomes (1)
self-reported questionnaire for painful
Self reported questionnaire with questions to assess the characteristic,intensity of pain on quality of life, and consumption of analgesic.
Measured: maximum 1 week from baseline on
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start27 Apr 2020
- Primary completion4 May 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René-Marc FLIPO, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351399
- Sponsor's protocol ID
- 2020_29
- Other IDs
- 2020-A00907-32
- Acronym
- PRPsyCOVID
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
- ClinicalTrials.gov ID
- NCT04351399
- Acronym / sponsor ID
- PRPsyCOVID / 2020_29
- Conditions
- Sars-CoV2, Rheumatic Diseases, Rheumatoid Arthritis, Chronic Pain
- Keywords
- Psychological impact, COVID-19, Rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 17 Apr 2020 (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.
Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration.
In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression.
During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients.
The present study is an "emergency" being realize before the end of the quarantine.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with chronic painful inflammatory rheumatism | – | Other: questionnaire assesment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patient will be interviewed par internet questionnaire (patient association / ANDAR)
Key inclusion criteria (1 listed)
- Rheumatoid arthritis Quarantine
Key exclusion criteria (1 listed)
- Non adult patient RA patient without quarantine
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 |
|---|---|---|
| questionnaire assesmentThe questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine | Other | patient with chronic painful inflammatory rheumatism |
Primary outcome
Frequency of RA patients with emotional impact (feeling of isolation)
Time frame: maximum 1 week from baseline on
1 secondary outcome
self-reported questionnaire for painful
Time frame: maximum 1 week from baseline on
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 11 Dec 2020.
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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.
René-Marc FLIPO, MD,PhD principal investigator
University Hospital, Lille
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 Sars-CoV2 and Rheumatic Diseases, run by University Hospital, Lille 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 11 Dec 2020. 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?
Frequency of RA patients with emotional impact (feeling of isolation) (time frame: maximum 1 week from baseline on). 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 11 Dec 2020.