Creating and testing a quality of life questionnaire for cardiac sarcoidosis patients
Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
This study is trying to create and test a new questionnaire to help understand how cardiac sarcoidosis affects the daily lives of patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 2 sites (Cambridge and 1 other locations) |
| Trial ID | NCT05145023 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a new questionnaire, the CARD-SARC, specifically designed to measure health-related quality of life in patients with cardiac sarcoidosis. It involves interviewing patients to understand the impact of their condition on daily life, followed by the creation of a draft questionnaire. The draft will then be tested for reliability and validity by having patients complete it alongside established quality of life measures. The study is conducted across two NHS specialist centers in the UK.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of cardiac sarcoidosis attending outpatient clinics at specialist centers.
Not a fit: Patients who are unable or unwilling to provide informed consent or complete the study questionnaires will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for assessing quality of life in cardiac sarcoidosis patients, leading to better patient care and management.
How similar studies have performed: While the approach of developing a specific quality of life tool for cardiac sarcoidosis is relatively novel, similar studies have successfully created and validated quality of life questionnaires for other chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Unable or unwilling to give informed consent * Unable or unwilling to give and/or complete the study questionnaires • Inability to understand written and/or verbal English
Where this trial is running
Cambridge and 1 other locations
- Royal Papworth Hospital NHS Foundation Trust — Cambridge, United Kingdom (Not_yet_recruiting)
- St Bartholomew's Hospital - Barts Health NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Juan Carlos Quijano-Campos, BSc,MSC
- Email: j.c.quijano-campos@qmul.ac.uk
- Phone: 02078822253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.