NCT02388542

Effect of Peer-mentor Mediated Interventions on Cardiovascular Risk Factors at Worksites

Policy and Peer Mentor Intervention Programs on Cardiovascular Disease at Small to Medium Sized Worksites in 3 South Asian Countries - a Pilot Study for a Definitive Large International Cluster Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: St. John's Research Institute · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention to improve life style and enhance medication adherence among those at moderate to high risk of cardiovascular disease (CVD).

Detailed description

Eligibility Criteria - All employees aged above 35 years at selected workplaces. Study design - Mixed methods methods Phase 1 - Qualitative study; Phase 2 - Quantitative - Single group, non-randomized before-after comparison study + KAP survey Sample size - Approximately 334 participants. The study entails the following steps - Step 1 - An evaluation for knowledge, attitudes and practices (KAP) related to cardiovascular health/ disease at worksites. Step 2 - A qualitative study for barriers and facilitators of behaviors associated with optimal cardiovascular health Step 3 - Baseline assessment of cardiovascular risk using a non-lab based risk assessment score Step 4 - Piloting a trained peer mentored educational/ intensive follow-up intervention for 3 month with a re-assessment at 3 months.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	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 life style medication and adherence to medication (if applicable).importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle(tobacco, physical acitivity, diet, alcohol and strees) and adherence to cardiovascular disease prevention medication. peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal valves, provide lifestyle counseling and refer to treating physician when appropriate.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-03-17
• Last updated: 2017-09-14

Locations

6 sites across 3 countries: Bangladesh, India, Sri Lanka