Coronary Artery DiseaseNCT04271566
Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic
A study testing Education program in people with Coronary Artery Disease, run by KR Mangalam University at 1 site in India.
Trial summary
This study has two parts: A drug utilization study and a Health-related quality of life study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults 18 - 75 years of age
- Diagnosed cased of coronary artery disease
- Agreeing after informed consent to participate
Who cannot join
- High risk cardiac patients
- Systemic, orthopedic and/or neurological problems restricting physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Utilization and Quality of Life Study in Coronary Artery Disease Patients in a North Indian Tertiary Care Center
This study has two parts: A drug utilization study and a Health-related quality of life study.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Education program
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients receiving an education program along with usual medical care Receives: Behavioral: Education program |
| Non Experimental | No intervention | Patients receiving usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (1)
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Mar 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- KR Mangalam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yojna Sah Jain, KR Mangalam University
- Investigators
- Yojna Jain, Masters, Principal investigator, KR Mangalam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271566
- Sponsor's protocol ID
- HappyHeartTrial
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34741536
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization and Quality of Life Study in Coronary Artery Disease Patients in a North Indian Tertiary Care Center
- ClinicalTrials.gov ID
- NCT04271566
- Acronym / sponsor ID
- HappyHeartTrial
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- KR Mangalam UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Education programPatients receiving an education program along with usual medical care |
| Non Experimental | No intervention | –Patients receiving usual medical care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adults 18 - 75 years of age
- Diagnosed cased of coronary artery disease
- Agreeing after informed consent to participate
Key exclusion criteria (2 listed)
- High risk cardiac patients
- Systemic, orthopedic and/or neurological problems restricting physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education programA 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 | Behavioural | Experimental |
Primary outcome
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.
1 secondary outcome
Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 34741536Dibben 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yojna Jain, Masters principal investigator
KR Mangalam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program in people with Coronary Artery Disease, run by KR Mangalam University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQOL measured by RAND-Short form (SF)- 36 questionnaire (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04271566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.