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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04271566
Enrollment
312
Registered
2020-02-17
Start date
2018-03-01
Completion date
2019-07-31
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

BEHAVIORALEducation 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

Sponsors

KR Mangalam University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HRQOL measured by RAND-Short form (SF)- 36 questionnaire9 monthsHealth 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

MeasureTime frameDescription
Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form9 monthsPhysical 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

MeasureTime frameDescription
Body mass index9 monthsBody mass index for all patients

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026