Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- To develop and validate a disease-specific HRQoL tool (CARD-SARC) for people diagnosed with cardiac sarcoidosis.
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
To develop and validate a disease-specific HRQoL tool (CARD-SARC) for people diagnosed with cardiac sarcoidosis.
时间窗: 12 months
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).
次要结局
- The CARD-SARC questionnaire (new HRQoL-questionnaire for cardiac sarcoidosis).(12 months)
- The Hospital Anxiety and Depression Scale (HADS).(12 months)
- The 5-Levels of severity for the EuroQoL 5- Dimensions (EQ5D-5L) questionnaire.(12 months)
- The Sarcoidosis Health Questionnaire (SHQ) questionnaire.(12 months)
- The King's Sarcoidosis Questionnaire (KSQ) questionnaire.(12 months)
- The Short-form 36 (SF-36) questionnaire.(12 months)
- The Sarcoidosis Assessment Tool (SAT).(12 months)
- The Fatigue Assessment Scale (FAS).(12 months)