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

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

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).

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Educational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Appollo Ispat Complex Ltd
  • Dhaka, Bangladesh
    • Shardharan Bima Coorporation
• India
  • Bangalore, India
    • Bharat Heavy Electrical Limited
  • Hosur, India
    • TVS Motor company Limited
• Sri Lanka
  • Colombo, Sri Lanka
    • Department of Census & Statistics
  • Colombo, Sri Lanka
    • Sri Lanka Telecom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 relocate during the study period.
  5. Unwilling or unable to comply with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: lifestyle counseling; we will have a trained peer mentor educating employees regarding lifestyle modification for control of cardiovascular disease risk factors and following them up for a duration of 3 months

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)	A knowledge, attitudes & practices questionnaire will be administered to participants	1 Month
Identification of barriers and facilitators for an optimal Cardiovascular Health environment. (In depth interviews and focus groups discussions with random sample of participants)	qualitative analysis - In depth interviews and focus groups discussions with random sample of participants	3 Months
Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)	validated non lab based Cardiovascular risk score will be used (developed from NHANES data and validated against Framingham score	3 Months

Collaborators and Investigators

• Sponsor: St. John's Research Institute
• Collaborators: University of Oxford; International Centre for Diarrhoeal Disease Research, Bangladesh; University of Colombo
• Investigators: Principal Investigator: Dr Denis Xavier, M.D,MSc., St.John's Medical College

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: cardiovascular disease; education; peer mentor
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PROGRESS-IND-1022015