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

NCT ID: NCT04542031

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1010 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Rheumatic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Survey

Survey to be distributed at 6 and 12 months

Group Type OTHER

Questionnaire

Intervention Type OTHER

Questionnaire to be completed at 6 and 12 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

Questionnaire to be completed at 6 and 12 months

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Royal Wolverhampton Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James Bateman

Role: PRINCIPAL_INVESTIGATOR

The Royal Wolverhampton NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Cox N, Raizada SR, Barkham N, Venkatachalam S, Sheeran TP, Adizie T, Sapkota H, Scott IC, Muller S, Bateman J. The impact of the COVID-19 pandemic and stringent social distancing measures on health-related quality of life and COVID-19 infection rates in patients with rheumatic disease: a longitudinal analysis through the pandemic. Rheumatol Adv Pract. 2023 Jan 16;7(1):rkad009. doi: 10.1093/rap/rkad009. eCollection 2023.

Reference Type DERIVED
PMID: 36751643 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020COV113

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COVID-19 Vaccination in Rheumatic Disease Patients
NCT04839315 TERMINATED EARLY_PHASE1