Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Education program
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Paras Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Non Experimental
Arm Description
Patients receiving an education program along with usual medical care
Patients receiving usual medical care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04271566
First Posted
February 12, 2020
Last Updated
February 14, 2020
Sponsor
KR Mangalam University
1. Study Identification
Unique Protocol Identification Number
NCT04271566
Brief Title
Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic
Official Title
Drug Utilization and Quality of Life Study in Coronary Artery Disease Patients in a North Indian Tertiary Care Center
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KR Mangalam University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients receiving an education program along with usual medical care
Arm Title
Non Experimental
Arm Type
No Intervention
Arm Description
Patients receiving usual medical care
Intervention Type
Behavioral
Intervention Name(s)
Education program
Intervention Description
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 Outcome Measure Information:
Title
HRQOL measured by RAND-Short form (SF)- 36 questionnaire
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form
Description
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.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Body mass index
Description
Body mass index for all patients
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yojna Jain, Masters
Organizational Affiliation
KR Mangalam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paras Hospital
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34741536
Citation
Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
Results Reference
derived
Learn more about this trial
Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic
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