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

NCT ID: NCT02388542

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Cardiovascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

University of Colombo

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

St. John's Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Denis Xavier, M.D,MSc.

Role: PRINCIPAL_INVESTIGATOR

St.John's Medical College

Locations

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Appollo Ispat Complex Ltd

Dhaka, , Bangladesh

Site Status

Shardharan Bima Coorporation

Dhaka, , Bangladesh

Site Status

Bharat Heavy Electrical Limited

Bangalore, , India

Site Status

TVS Motor company Limited

Hosūr, , India

Site Status

Department of Census & Statistics

Colombo, , Sri Lanka

Site Status

Sri Lanka Telecom

Colombo, , Sri Lanka

Site Status

Countries

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Bangladesh India Sri Lanka

Other Identifiers

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PROGRESS-IND-1022015

Identifier Type: -

Identifier Source: org_study_id

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