Assessing somatic symptom burden in patients with suspected coronary artery disease
The Validation of the Somatic Symptom Scale China (SSS-CN) for Assessing Somatic Symptom Burden and Its Utility in Patients With Suspected Coronary Artery Disease
RenJi Hospital · NCT03321409
This study is testing a new questionnaire to see how well it measures physical symptoms in people who might have coronary artery disease and how those symptoms affect their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT03321409 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the reliability and validity of the Somatic Symptom Scale China (SSS-CN) compared to the widely used Patient Health Questionnaire-15 (PHQ-15) in assessing somatic symptom burden. The study will involve patients with suspected coronary artery disease (CAD) across multiple centers, focusing on the prevalence of somatic symptoms and their impact on quality of life. By utilizing a comprehensive self-report instrument, the research seeks to enhance understanding of somatic symptoms in this patient population and improve evidence-based patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals undergoing physical examinations at Renji Hospital who are suspected of having coronary artery disease.
Not a fit: Patients with previously confirmed serious medical or mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment tools for somatic symptoms, enhancing patient care and treatment outcomes for those with suspected CAD.
How similar studies have performed: While the SSS-CN is a novel instrument, the approach of assessing somatic symptoms has shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. People who take the physical examination in Renji Hospital. 2. Patients with suspected CAD. Exclusion Criteria: 1. People who have been previously confirmed serious medical conditions. 2. People who have been previously confirmed serious mental disorders.
Where this trial is running
Shanghai
- Renji Hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Meng Jiang, MD
- Email: jiangmeng0919@163.com
- Phone: 13788912766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Somatization Disorder, Somatic symptom, SSS-CN, PHQ-15, Suspected CAD, Coronary angiography