COVID-19 in a Single Large UK Rheumatology Centre and Impact on QOL (CRISP)
Primary Purpose
Covid19, Rheumatic Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional other trial for Covid19
Eligibility Criteria
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
Sites / Locations
- The Royal Wolverhampton NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Survey
Arm Description
Survey to be distributed at 6 and 12 months
Outcomes
Primary Outcome Measures
Prevalence of COVID 19
percentage of cases
Mortality rates from COVID 19
number of deaths per 1000 individuals
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04542031
First Posted
September 7, 2020
Last Updated
January 4, 2022
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04542031
Brief Title
COVID-19 in a Single Large UK Rheumatology Centre and Impact on QOL
Acronym
CRISP
Official Title
COVID-19 Prevalence in a Single Large UK Rheumatology Centre and the Impact on Quality of Life From Stringent Social Distancing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Wolverhampton Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Rheumatic Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7911 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Survey
Arm Type
Other
Arm Description
Survey to be distributed at 6 and 12 months
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Questionnaire to be completed at 6 and 12 months
Primary Outcome Measure Information:
Title
Prevalence of COVID 19
Description
percentage of cases
Time Frame
1 year
Title
Mortality rates from COVID 19
Description
number of deaths per 1000 individuals
Time Frame
1 year
Title
Health related quality of life - Short Form 12
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Bateman
Phone
01902307999
Email
jamesbateman@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Cleaton
Email
natasha.cleaton@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Bateman
Organizational Affiliation
The Royal Wolverhampton NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Bateman
Email
jamesbateman@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 in a Single Large UK Rheumatology Centre and Impact on QOL
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