Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Education program

• Registration Number: NCT04271566
• Lead Sponsor: KR Mangalam University

Brief Summary

This study has two parts: A drug utilization study and a Health-related quality of life study.

Detailed Description

This study has two parts: A drug utilization study and a Health-related quality of life study.

Drug utilisation study is an open label, cross sectional, descriptive drug utilization analysis of the primary cardiovascular drug classes prescribed to coronary artery disease patients attending cardiology OPD of a North India hospital.

Quality of life study intended to evaluate impact of a mobile based patient education program on the health related quality of life, physical activity and body mass index of coronary artery disease patients. It is a two arm study.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-14
• Last Update Submitted: 2020-02-14
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• Male or female adults 18 - 75 years of age
• Diagnosed cased of coronary artery disease
• Agreeing after informed consent to participate

Exclusion Criteria

• High risk cardiac patients
• Systemic, orthopedic and/or neurological problems restricting physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Education program	Patients receiving an education program along with usual medical care

Primary Outcome Measures

Name	Time	Method
HRQOL measured by RAND-Short form (SF)- 36 questionnaire	9 months	Health related quality of life to be measured using RAND-Short form (SF)- 36 questionnaire. This questionnaire comprises of 36 questions that measure HRQOL across 8 different domains that can be summarised into physical, mental and general health summary scores. Higher the SF 36 domain scores, better is the quality of life.

Secondary Outcome Measures

Name	Time	Method
Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form	9 months	Physical activity of the participants to be measured using International Physical Activity Questionnaire (IPAQ)- Short Form. It measures physical vigorous and moderate physical activity along with time spent in walking and sedentary activities. Higher the IPAQ score, higher is the physical activity.

Trial Locations

Locations (1)

Paras Hospital; 🇮🇳 Gurgaon, Haryana, India