Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis

Queen Mary University of London

Status: Enrolling

Conditions: Cardiac Sarcoidosis

Study type: Observational

Funder types: Other

Identifiers

NCT05145023

143251

256815 (Other Identifier)

Details and patient eligibility

About

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.

Full description

What would taking part involve?

First, we would like to talk with a group of patients (between 6 to 20) about the impact of cardiac sarcoidosis in their quality of life during an interview. We will review and analysed these interviews. Then, we will compare with what is already know about cardiac sarcoidosis and its impact on quality of life. Also, we will ask healthcare professionals working with cardiac sarcoidosis patients to review our results. Finally, we will use this information to create the first draft of the new questionnaire (CARD-SARC questionnaire)to measure quality of life in cardiac sarcoidosis patients.

Second, we will ask 20 patients with cardiac sarcoidosis to complete the draft version of the CARD-SARC questionnaire. Also, they will complete validated quality of life questionnaires (for general population or sarcoidosis patients) and questionnaires that explore potential symptoms of fatigue, anxiety and depression. We will compare an review these results to confirm that the CARD-SARC questionnaire is ready for evaluation.

Third, we will ask 100 cardiac sarcoidosis patients to complete the CARD-SARC questionnaire and the validated questionnaires (for quality of life and potential sarcoidosis symptoms) to evaluate how good the CARD-SARC is at measuring quality of life changes in cardiac sarcoidosis patients.

How will patients or the public help guide the research?

This work has been influenced and designed with people living with cardiac sarcoidosis. SarcoidosisUK, the UK sarcoidosis charity, has been supportive and engaged on this work. Likewise, five expert patients with cardiac sarcoidosis have also agreed to lead, contribute and advice on relevant aspects of the study, and to participate sharing the results to the public, patients and professional groups.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Development of the CARD-SARC (n=20)

Description:

* 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)

Description:

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.