A Research project to reduce the risk of heart attack and strokes at work place.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/11/007465
• Date of registration: 10-11-2016
• Prospective Registration: No
• Primary sponsor: CBCI Society for Medical Education
• Public title: A Research project to reduce the risk of heart attack and strokes at work place.
• Scientific title: Policy and peer mentor intervention programs on cardiovascular disease at small to medium sized worksites in 3 South Asian countries - PROGRESS
• Date of first enrolment: 15-02-2016
• Target sample size: 3000
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10592
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

Bangladesh, India, Sri Lanka

Contacts

• Name: Dr Deepak Kamath MD
• Affiliation: Division of Clinical Research and Training

• Name: Dr Deepak Kamath MD
• Affiliation: Division of Clinical Research and Training

Key inclusion & exclusion criteria

Inclusion criteria: (All criteria must be met to be eligible)



1.Employees(Men & Women)above the age of 35 years.

2.Permanent employees with at least 6 months for retirement.

3.Willing to provide Informed Consent.
Exclusion criteria: (Subject ineligible if even one criterion is met)



1.Pregnant or intent to get pregnant in one year.

2.Inability to attend follow up visits.

3.Any active malignancy or Known malignancy on treatment.

4.Will be relocated during the study period.

5.Unwilling or unable to comply with study procedures.

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Educational Intervention.: Employees above the age of 35 years will be risk stratified into moderate or high risk of developing cardiovascular disease using a simple non-lab based risk scoring system. They will be invited to participate in the pilot intervention study. This is a single arm before-after study. Subject education will focus on lifestyle modification and adherence to medication(If applicable). Importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle(tobacco, physical activity, diet, alcohol and stress) and adherence to Cardio Vascular Disease prevention medications (which are already prescribed by their treating physician). The peer mentor will be trained to detect and refer (to treating physician or company panel doctor) participants who have a high blood pressure. Peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal values, provide lifestyle counseling and refer to treating physician when appropriate.
Control Intervention1: Not Applicable: Not Applicable

Primary Outcome(s)

1)Change in knowledge attitudes & practices related to Cardio Vascular (CV) risk factors.

2)Identification of barriers and facilitators for an optimal Cardio Vascular Disease (CVD) environment.

3) Estimate the CardioVascular (CV) risk burden at 6 worksites in 3 countries using a non-lab based risk scoring system.

4) Feasibility and acceptability of the interventions to reduce cardiovascular risk.Timepoint: 3 Months

Secondary Outcome(s)

1) Identify & Train Peer Mentors (PMs) to deliver an educational intervention.

2) Change in Blood Pressure among identified hypertensives (The study is not powered to detect this change at 3 month.)Timepoint: 3 Months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Medical Research council(UK), 2nd Floor David Philips Buiding, Polaris House, North Star Avenue Swindon wiltshire SN21F1, United Kindgom. Grant ref. no.MR/M019624/1

Ethics review

Status: Approved
Approval date: 05/12/2014
Contact:

Institutional Ethics Committee, St.Johns National Academy of Health Sciences,Bangalore.