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

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

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients receiving an education program along with usual medical care | Behavioral: Education program<br>* 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<br>|
| No Intervention: Non Experimental<br>Patients receiving usual medical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |