Clinical trial NCT05145023: Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
Official title: Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Sarcoidosis
Keywords: cardiac sarcoidosis
health-related quality of life
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
name: Papworth Hospital NHS Foundation Trust
First posted: 2021-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Using the WASOG criteria, participants will be adult patients attending the Outpatients Department 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.

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: To develop and validate a disease-specific HRQoL tool (CARD-SARC) for people diagnosed with cardiac sarcoidosis.
timeFrame: 12 months
Secondary outcomes:
measure: The CARD-SARC questionnaire (new HRQoL-questionnaire for cardiac sarcoidosis).
timeFrame: 12 months
measure: The 5-Levels of severity for the EuroQoL 5- Dimensions (EQ5D-5L) questionnaire.
timeFrame: 12 months
measure: The Short-form 36 (SF-36) questionnaire.
timeFrame: 12 months
measure: The Sarcoidosis Health Questionnaire (SHQ) questionnaire.
timeFrame: 12 months
measure: The King's Sarcoidosis Questionnaire (KSQ) questionnaire.
timeFrame: 12 months
measure: The Sarcoidosis Assessment Tool (SAT).
timeFrame: 12 months
measure: The Fatigue Assessment Scale (FAS).
timeFrame: 12 months
measure: The Hospital Anxiety and Depression Scale (HADS).
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St Bartholomew's Hospital - Barts Health NHS Trust
Study officials:
References: