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
1 other identifier
interventional
312
1 country
1
Brief Summary
This study has two parts: A drug utilization study and a Health-related quality of life study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Mar 2018
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedFirst Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedFebruary 17, 2020
February 1, 2020
1.4 years
February 12, 2020
February 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form
9 months
Other Outcomes (1)
Body mass index
9 months
Study Arms (2)
Experimental
EXPERIMENTALPatients receiving an education program along with usual medical care
Non Experimental
NO INTERVENTIONPatients receiving usual medical care
Interventions
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
Eligibility Criteria
You may qualify if:
- Male or female adults 18 - 75 years of age
- Diagnosed cased of coronary artery disease
- Agreeing after informed consent to participate
You may not qualify if:
- High risk cardiac patients
- Systemic, orthopedic and/or neurological problems restricting physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paras Hospital
Gurgaon, Haryana, 122002, India
Related Publications (1)
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.
PMID: 34741536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yojna Jain, Masters
KR Mangalam University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scholar
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 17, 2020
Study Start
March 1, 2018
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share