Condition category
Skin and Connective Tissue Diseases
Date applied
27/06/2016
Date assigned
20/09/2016
Last edited
20/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Psoriasis is a common skin disorder affecting over 1 million people in England. There are many health complications which are associated with psoriasis. The purpose of the TUDOR study is to find out whether diagnosing psoriasis related health complications earlier (than normally in standard NHS care) leads to an improvement in physical health of the patient.

Who can participate?
Psoriasis patients between the ages of 18-70 who meet the study inclusion criteria can take part in the study.

What does the study involve?
People who participate in this study will need to complete questionnaires regarding their condition and attend clinical assessments which will include a physical examination.

What are the possible benefits and risks of participating?
By participating in the TUDOR study participants will be benefiting from a clinical assessment of their psoriasis by a qualified clinician, meaning that the severity of their condition and associated symptoms will be assessed by a qualified clinician. Participating in the study will also provide the research team with vital information about living with psoriasis and the measures that may need to be put in place to improve the care and support of psoriasis patients in the future. However taking time in the study requires time commitment to complete the study questionnaires and attend the clinical assessments. Some of the questions asked at the clinical assessments maybe of a personal or sensitive nature.

Where is the study run from?
The study will be carried out in 4 centres in the UK. Participants will be invited to take part in the study by their GPs via a postal invitation letter. GPs will identify potential participants from their practice database.

When is the study starting and how long is it expected to run for?
June 2015 to May 2020

Who is funding the study?
National Institute for Health Research

Who is the main contact?
Ms Claire Davies – Senior Trial Manager

Trial website

Contact information

Type

Public

Primary contact

Mrs Saila Waseem

ORCID ID

Contact details

Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31138

Study information

Scientific title

TUDOR – Total Burden of Psoriasis

Acronym

TUDOR

Study hypothesis

The aim of the TUDOR study is to find out whether diagnosing psoriasis related health complications earlier (than normally in standard NHS care) leads to an improvement in physical health of the patient.

Ethics approval

South West – Central Bristol Research Ethics Committee, 20/06/2016, ref: 16/SW/0161

Study design

Randomised; Interventional; Design type: Screening, Process of Care, Active Monitoring

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Specialty: Primary Care, Disease: Skin/ Papulosquamous disorders, Inflammatory/ Certain disorders involving the immune mechanism

Intervention

1. Clinical Assessment including a physical examination and completion of questionnaires related to psoriasis and quality of life (QoL)
2. Participants in the standard care arm of the trial will be requested to complete postal questionnaires regarding their condition and QoL at baseline and 12 months from trial registration date. Participants will then be invited to attend a clinical assessment at 24 months and also complete further questionnaires at the assessment visit
3. Participants in the trial arm will be invited to attend clinical assessments at baseline, 12 months and at 24 months. At each of the assessment visits participants will be requested to complete the same questionnaires as the standard care arm participants

Intervention type

Other

Phase

Drug names

Primary outcome measures

Physical function, measured by the Health Assessment Questionnaire and Disability Index (HAQ-DI) score at 24 months.

The primary outcome will be analysed using a fixed effects zero-inflated beta regression model adjusting for the stratification factors, HAQ-DI measured at baseline, other relevant baseline covariates, and treatment arm.

Secondary outcome measures

1. Disease activity for people diagnosed with psoriatic complications at 24 months post registration. Disease specific questionnaires will be analysed using multivariable fixed effects models, adjusting for the stratification factors and relevant baseline covariates. This will be based on data collected at 24 months post registration.
2. The diagnostic accuracy of an updated symptom questionnaire for identification of psoriatic disease. The diagnostic accuracy of the questionnaire will be assessed by estimating of the sensitivity and specificity, positive and negative predictive values, and AUCs of the questionnaires, against the gold standard for diagnosing psoriatic disease. Regression-based sensitivity analysis, incorporating the possibility of dependence in the outcomes will be utilised to explore the additional explanatory power of the updated questionnaire. This will be measured either at baseline or 24 months depending upon the arm of the study.
3. To compare the sensitivity and specificity of the updated symptom screening tool with the symptom questionnaire currently approved for use in standard care. The differences between the updated and the currently approved questionnaires in terms of their sensitivity and specificity, positive and negative predictive values, and AUCs will be assessed. Where participants have completed both questionnaires, adjusted McNemar's tests, which account for clustered data, will be used to compare sensitivity and specificity. To examine the optimal method for screening for psoriatic disease, diagnostic questionnaires and their different cut points will be compared using receiver operator characteristic (ROC) curve analysis. This will be measured either at baseline or 24 months depending upon the arm of the study.
4. The impact of psoriatic complications on health-related quality of life and work productivity.
Quality of Life and Work Productivity questionnaires will be analysed using a mixed effects model, adjusting
for the stratification factors, other relevant baseline covariates and treatment arm. The model will also adjust for fixed effects as well as random effects where relevant.
5. To identify risk factors associated with a longer duration to diagnosis of psoriasis related health complications. Mixed effects generalised additive models will be used to assess the association between age, sex and psoriasis severity on time to diagnosis in patients diagnosed with psoriasis related health complications, allowing for the possibility of non-linear effects between explanatory variables and response.
6. The association between severity of psoriasis and the development of psoriasis related health complications. The development of psoriasis related health complications will be analysed using a fixed effects zero-inflated beta regression model adjusting for the stratification factors, SAPASI (psoriasis severity measure), HAQ-DI measured at baseline, other relevant baseline covariates and treatment arm, at 24 months post registration.
7. To explore the extent to which certain candidate risk factors are associated with the development of psoriatic disease in people with psoriasis. Mixed effects generalised (logistic) effects models will be used to assess the extent to which age, sex, psoriasis severity, psoriatic disease duration and other risk factors are associated with the development of psoriatic complications in people with psoriasis.
8. The prevalence of inflammatory back pain in people with psoriasis. The prevalence of inflammatory back pain in the trial population will be calculated, together with 95% confidence intervals at baseline and at 12 and 24 months, depending on the arm of the study. The incidence of inflammatory back pain in the ES arms will be calculated, together with 95% confidence intervals at the 12 and 24 month assessments.

Overall trial start date

01/06/2015

Overall trial end date

31/05/2020

Reason abandoned

Eligibility

Participant inclusion criteria

At all participating GP practices, patients will be eligible to take part in the trial if they meet the following criteria:
1. Males and females age 18-70 at time of recruitment
2. Their primary care record contains a Read Code for psoriasis at any time prior to their date of recruitment
3. Able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Between 1916 and 2384 participants (depending on the number of GP practices opened to recruitment, number of participants recruited per GP practice and the drop-out rate of participants and GP practices) UK Sample Size: 1916-2384

Participant exclusion criteria

Participant Exclusion Criteria:
1. A prior diagnosis of psoriatic complications relevant to the study
2. Inability to comply with the study follow-up schedule
3. Unsuitable to participate in the study as determined by the screening GP
4. Previously participated in the TUDOR trial (in the case of participants who may move between participating GP practices due to house move or other reasons)

Recruitment start date

01/08/2016

Recruitment end date

31/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal United Hospitals Bath NHS Foundation Trust (lead centre)
Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

St Luke’s Hospitals
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Trial participating centre

Haywood Hospital, Staffordshire and Stoke-on-Trent Partnership NHS Trust
Morston House The Midway Newcastle-under-Lyme
Staffordshire
ST5 1QG
United Kingdom

Trial participating centre

Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom

Sponsor information

Organisation

Royal United Hospitals Bath NHS Foundation Trust

Sponsor details

Combe Park
Bath
Avon
Somerset
BA1 3NG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

31/05/2021

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes