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OpenTrials
Completed

NCT Number: NCT04542031

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

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.

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Key information

Conditions

Covid19 COVID-19 Connective Tissue Diseases Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Musculoskeletal Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rheumatic Diseases Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Questionnaire to be completed at 6 and 12 months

Primary outcomes

  1. Prevalence of COVID 19

    Time frame: 1 year

    percentage of cases

  2. Mortality rates from COVID 19

    Time frame: 1 year

    number of deaths per 1000 individuals

  3. 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

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: CRISP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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