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

Coronary Artery Disease Clinical Trial

Official title:

Drug Utilization and Quality of Life Study in Coronary Artery Disease Patients in a North Indian Tertiary Care Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271566
• Other study ID #: HappyHeartTrial
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2020
• Source: KR Mangalam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Education program
A mobile application plus short message service (SMS) program to deliver disease-related health education and reinforcement to experimental group patients and see its impact on their health related quality of life, physical activity and Body mass index

Locations

Country	Name	City	State
India	Paras Hospital	Gurgaon	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
KR Mangalam University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	Body mass index for all patients	9 months
Primary	HRQOL measured by RAND-Short form (SF)- 36 questionnaire	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.	9 months
Secondary	Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form	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.	9 months