A questionnaire based validation study in patients with stable angina.

Completed

• Conditions: Other forms of angina pectoris,

• Registration Number: CTRI/2018/08/015492
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

This is a cross sectional, non interventional single visit study to validate the OPTA questionnaires. No drug/Intervention is involved in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-09
• Study Completion: 2019-04-01
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male and female patients >18 years of age 2.
• Patients who have completed at least 10 years of school education 3.
• Patients with a confirmed history of chronic stable angina documented in their medical records and who are on medical therapy for at least the past 6 months 4.
• Patients who have reported ≥1 episodes of angina in the past 6 months 5.
• Patients who are willing and able to respond to the face validation of the questionnaire.

Exclusion Criteria

• Patients with a history of coronary artery bypass grafting within the past 6 months 2.
• Patients with a history of ACS and/or percutaneous transluminal coronary angioplasty (PTCA) within the past 6 months 3.
• Any patient found to be unsuitable by the investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expert validation	6 months
b. Experts assigning a score ≤2 for content relevance for Q1 to Q5	6 months
Face validation (in patients):	6 months
a. Experts assigning a score ≤2 for clarity for Q1 to Q5	6 months
a. Patients disagreeing that the question correctly measures the specific area of cardiovascular health status for Q1 to Q5	6 months
b. Patients disagreeing that the responding options correctly capture the answers for Q1 to Q5	6 months

Trial Locations

Locations (1)

Dr Uday Jadhav Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr Uday Jadhav Clinic

🇮🇳Mumbai, MAHARASHTRA, India

Dr Uday Jadhav

Principal investigator

022-27576205

umjadhav@gmail.com