Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY
What is the purpose of this research? This study includes two parts based in two NHS specialist centres for cardiac sarcoidosis: * Development of the CARD-SARC: Development of the new questionnaire to measure quality of life in cardiac sarcoidosis patients (the CARD-SARC questionnaire) * Validation of the CARD-SARC: Evaluation of how good the CARD-SARC questionnaire is at measuring quality of life changes in patients with cardiac sarcoidosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:
• Adult (≥ 18 years)
• Patients with a probable (50-90% likelihood) or highly probable (\>90% likelihood) diagnosis of cardiac sarcoidosis (CS) by a multidisciplinary team meeting in a CS-specialist centre as per the WASOG criteria
• Patients attending outpatient clinics in a CS-specialist centre
Locations
Other Locations
United Kingdom
Royal Papworth Hospital NHS Foundation Trust
NOT_YET_RECRUITING
Cambridge
St Bartholomew's Hospital - Barts Health NHS Trust
RECRUITING
London
Contact Information
Primary
Juan Carlos Quijano-Campos, BSc,MSC
j.c.quijano-campos@qmul.ac.uk
02078822253
Backup
(JRMO) Joint Research Management Office
research.governance@qmul.ac.uk
Time Frame
Start Date: 2022-01-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 120
Treatments
Development of the CARD-SARC (n=20)
* Interviews: 6-20 participants (depending of data saturation) will be recruited using a convenience sampling strategy.~* Field-testing: 20 participants using a convenience/consecutive sampling strategy.
Validation of the CARD-SARC (n=100)
The CS-specialist centres (Barts Health NHS Trust and Royal Papworth Hospital NHS Foundation Trust) have a cohort of 60-70 potential candidates in each site. The estimated sample size for the Pilot-testing is 100 study participants, considering previous sarcoidosis studies including PROMs, with less than 10% population declining participation or failing to complete their questionnaires.
Authors
Juan Carlos Quijano-Campos
Related Therapeutic Areas
Sponsors
Leads: Queen Mary University of London
Collaborators: Barts & The London NHS Trust, Papworth Hospital NHS Foundation Trust