COVID-19 in a Single Large UK Rheumatology Centre and Impact on QOL

Covid19 Clinical Trial

— CRISP  

Official title:

COVID-19 Prevalence in a Single Large UK Rheumatology Centre and the Impact on Quality of Life From Stringent Social Distancing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542031
• Other study ID #: 2020COV113
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• Covid19
• Rheumatic Diseases

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