NCT04542031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,010

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

September 7, 2020

Last Update Submit

January 2, 2025

Conditions

Covid19Rheumatic Diseases

Outcome Measures

Primary Outcomes (3)

  • Prevalence of COVID 19

    percentage of cases

    1 year

  • Mortality rates from COVID 19

    number of deaths per 1000 individuals

    1 year

  • 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

    1 year

Study Arms (1)

Survey

OTHER

Survey to be distributed at 6 and 12 months

Other: Questionnaire

Interventions

QuestionnaireOTHER

Questionnaire to be completed at 6 and 12 months

Survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All rheumatology patients under active follow up at the Royal Wolverhampton Trust with a validated mobile telephone number

You may not qualify if:

  • Patients without a validated mobile phone number linked to their hospital record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 36751643DERIVED

MeSH Terms

Conditions

COVID-19Rheumatic Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • James Bateman

    The Royal Wolverhampton NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 9, 2020

Study Start

December 14, 2020

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)