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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04542031
Other study ID # 2020COV113
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 14, 2020
Est. completion date February 1, 2022

Study information

Verified date December 2023
Source The Royal Wolverhampton Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 1010
Est. completion date February 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All rheumatology patients under active follow up at the Royal Wolverhampton Trust with a validated mobile telephone number Exclusion Criteria: - Patients without a validated mobile phone number linked to their hospital record

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Questionnaire to be completed at 6 and 12 months

Locations

Country Name City State
United Kingdom The Royal Wolverhampton NHS Trust Wolverhampton West Midlands

Sponsors (1)

Lead Sponsor Collaborator
The Royal Wolverhampton Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of COVID 19 percentage of cases 1 year
Primary Mortality rates from COVID 19 number of deaths per 1000 individuals 1 year
Primary 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 1 year
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