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

Not Applicable

Completed

• Conditions: Rheumatic Diseases; Covid19
• Interventions: Other: Questionnaire

• Registration Number: NCT04542031
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-09
• Study Start: 2020-12-14
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1010

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Survey	Questionnaire	Survey to be distributed at 6 and 12 months

Primary Outcome Measures

Name	Time	Method
Prevalence of COVID 19	1 year	percentage of cases
Mortality rates from COVID 19	1 year	number of deaths per 1000 individuals
Health related quality of life - Short Form 12	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

Trial Locations

Locations (1)

The Royal Wolverhampton NHS Trust; 🇬🇧 Wolverhampton, West Midlands, United Kingdom