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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04542031
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : September 16, 2020
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 Rheumatic Diseases Other: Questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7911 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: COVID-19 Prevalence in a Single Large UK Rheumatology Centre and the Impact on Quality of Life From Stringent Social Distancing
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

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

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04542031

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Contact: James Bateman 01902307999
Contact: Natasha Cleaton

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United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Contact: James Bateman   
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
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Principal Investigator: James Bateman The Royal Wolverhampton NHS Trust
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Responsible Party: The Royal Wolverhampton Hospitals NHS Trust Identifier: NCT04542031    
Other Study ID Numbers: 2020COV113
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases