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

Last updated: October 18, 2024
Sponsor: Queen Mary University of London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoidosis

Treatment

N/A

Clinical Study ID

NCT05145023
143251
256815
  • Ages 18-120
  • All Genders

Study 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 Criteria

Inclusion

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 aCS-specialist centre as per the WASOG criteria

  • Patients attending outpatient clinics in a CS-specialist centre

Exclusion

Exclusion Criteria:

  • Unable or unwilling to give informed consent

  • Unable or unwilling to give and/or complete the study questionnaires • Inability tounderstand written and/or verbal English

Study Design

Total Participants: 120
Study Start date:
January 10, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, CB20AY
    United Kingdom

    Site Not Available

  • St Bartholomew's Hospital - Barts Health NHS Trust

    London, EC1A 7DN
    United Kingdom

    Active - Recruiting

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