Covid19CRISPNCT04542031
COVID-19 in a Single Large UK Rheumatology Centre and Impact on QOL
A study testing Questionnaire in people with Covid19 and Rheumatic Diseases, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The COVID-19 pandemic represents a threat to rheumatology patients. National advice for patients to 'shield' is based on risk stratification of therapies and other risk factors. While the epidemiology of COVID-19 in the rheumatological population is largely unknown large case registries are beginning to show potential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Rheumatic Diseases
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2020to 1 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All rheumatology patients under active follow up at the Royal Wolverhampton Trust with a validated mobile telephone number
Who cannot join
- Patients without a validated mobile phone number linked to their hospital record
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
About this study
Official title: COVID-19 Prevalence in a Single Large UK Rheumatology Centre and the Impact on Quality of Life From Stringent Social Distancing
The COVID-19 pandemic represents a threat to rheumatology patients. National advice for patients to 'shield' is based on risk stratification of therapies and other risk factors. While the epidemiology of COVID-19 in the rheumatological population is largely unknown large case registries are beginning to show potential drug treatment interactions. Strict self-isolation (shielding) has been recommended for those deemed 'high risk' although its impact on the likelihood of COVID-19 infection and health related quality of life (HRQoL) is unclear.
The study aims to explore how this unprecedented situation has impacted the Trust patients primarily evaluating prevalence of the infection, effect of stringent social distancing (shielding) and Quality of Life (QOL). This will be done via a voluntary questionnaire, sent via text messaging at 6 and 12 months.
- Conditions
- Covid19, Rheumatic Diseases
- Being tested
- Questionnaire
- Medical subject headings
- COVID-19, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire to be completed at 6 and 12 months
| Study group | Role | What they receive |
|---|---|---|
| Survey | Other | Survey to be distributed at 6 and 12 months Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of COVID 19
percentage of cases
Measured: 1 year
Mortality rates from COVID 19
number of deaths per 1000 individuals
Measured: 1 year
Health related quality of life - Short Form 12
mental and physical component scores through patient reported outcomes. Normative score set at 50 with minimum score being 0 and maximum score being 100. Scores >50 indicate better mental or physical health than the mean. Scores <50 indicate worse mental or physical health than the mean
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start14 Dec 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- James Bateman, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542031
- Sponsor's protocol ID
- 2020COV113
- Acronym
- CRISP
- Status last verified
- Jan 2025
- First submitted
- 7 Sep 2020
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cox N, Raizada SR, Barkham N, Venkatachalam S, Sheeran TP, Adizie T, Sapkota H, Scott IC, Muller S, Bateman J. The impact of the COVID-19 pandemic and stringent social distancing measures on health-related quality of life and COVID-19 infection rates in patients with rheumatic disease: a longitudinal analysis through the pandemic. Rheumatol Adv Pract. 2023 Jan 16;7(1):rkad009. doi: 10.1093/rap/rkad009. eCollection 2023.
PubMed 36751643
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Prevalence in a Single Large UK Rheumatology Centre and the Impact on Quality of Life From Stringent Social Distancing
- ClinicalTrials.gov ID
- NCT04542031
- Acronym / sponsor ID
- CRISP / 2020COV113
- Conditions
- Covid19, Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 9 Sep 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.
The COVID-19 pandemic represents a threat to rheumatology patients. National advice for patients to 'shield' is based on risk stratification of therapies and other risk factors. While the epidemiology of COVID-19 in the rheumatological population is largely unknown large case registries are beginning to show potential drug treatment interactions. Strict self-isolation (shielding) has been recommended for those deemed 'high risk' although its impact on the likelihood of COVID-19 infection and health related quality of life (HRQoL) is unclear.
The study aims to explore how this unprecedented situation has impacted the Trust patients primarily evaluating prevalence of the infection, effect of stringent social distancing (shielding) and Quality of Life (QOL). This will be done via a voluntary questionnaire, sent via text messaging at 6 and 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | Other | Other: QuestionnaireSurvey to be distributed at 6 and 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All rheumatology patients under active follow up at the Royal Wolverhampton Trust with a validated mobile telephone number
Key exclusion criteria (1 listed)
- Patients without a validated mobile phone number linked to their hospital record
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 |
|---|---|---|
| QuestionnaireQuestionnaire to be completed at 6 and 12 months | Other | Survey |
Primary outcome
Prevalence of COVID 19
Time frame: 1 year
percentage of cases
Mortality rates from COVID 19
Time frame: 1 year
number of deaths per 1000 individuals
Health related quality of life - Short Form 12
Time frame: 1 year
mental and physical component scores through patient reported outcomes. Normative score set at 50 with minimum score being 0 and maximum score being 100. Scores >50 indicate better mental or physical health than the mean. Scores <50 indicate worse mental or physical health than the mean
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 6 Jan 2025.
- Derived from this study: PubMed 36751643Cox N, Raizada SR, Barkham N, Venkatachalam S, Sheeran TP, Adizie T, Sapkota H, Scott IC, Muller S, Bateman J. The impact of the COVID-19 pandemic and stringent social distancing measures on health-related quality of life and COVID-19 infection rates in patients with rheumatic disease: a longitudinal analysis through the pandemic. Rheumatol Adv Pract. 2023 Jan 16;7(1):rkad009. doi: 10.1093/rap/rkad009. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
James Bateman principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Covid19 and Rheumatic Diseases, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 6 Jan 2025. 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 United Kingdom. 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?
Prevalence of COVID 19 (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542031, which also lists 1 linked publication.
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 6 Jan 2025.