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

January 2, 2025 updated by: The Royal Wolverhampton Hospitals NHS Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1010

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Survey
Survey to be distributed at 6 and 12 months
Other: Questionnaire
Questionnaire to be completed at 6 and 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of COVID 19
Time Frame: 1 year
percentage of cases
1 year
Mortality rates from COVID 19
Time Frame: 1 year
number of deaths per 1000 individuals
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Investigators

  • Principal Investigator: James Bateman, The Royal Wolverhampton NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 7, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020COV113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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