Skip to main content
OpenTrials
Completed

NCT Number: NCT04271566

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paras Hospital

Gurgaon, Haryana, 122002, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education program

Behavioral

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

Primary outcomes

  1. HRQOL measured by RAND-Short form (SF)- 36 questionnaire

    Time frame: 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 outcomes

  1. Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form

    Time frame: 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.

Other outcomes

  1. Body mass index

    Time frame: 9 months

    Body mass index for all patients

Sponsors and collaborators

Lead sponsor

KR Mangalam University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.