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

NCT05145023 | Completed

• 2 other identifiers: 143251256815
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Sarcoidosis

Keywords

cardiac sarcoidosis; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• To develop and validate a disease-specific HRQoL tool (CARD-SARC) for people diagnosed with cardiac sarcoidosis.

  Patient-related research activities include semi-structured interviews for item generation (McMaster framework step 1 - item selection), field-testing for the development of the CARD-SARC questionnaire (McMaster framework step 3 - item reduction) and a pilot-testing for the validation of the CARD-SARC (steps 4-6 - determination of reliability, validity and responsiveness).

  12 months

Secondary Outcomes (8)

• The CARD-SARC questionnaire (new HRQoL-questionnaire for cardiac sarcoidosis).

  12 months

• The 5-Levels of severity for the EuroQoL 5- Dimensions (EQ5D-5L) questionnaire.

  12 months

• The Short-form 36 (SF-36) questionnaire.

  12 months

• The Sarcoidosis Health Questionnaire (SHQ) questionnaire.

  12 months

• The King's Sarcoidosis Questionnaire (KSQ) questionnaire.

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts & The London NHS Trust: collaborator
• Papworth Hospital NHS Foundation Trust: collaborator

Study Sites (2)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, CB20AY, United Kingdom

Location

St Bartholomew's Hospital - Barts Health NHS Trust

London, EC1A 7DN, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 6, 2021
• Study Start: November 11, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)