NCT02388542

Brief 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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
3 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

February 9, 2015

Last Update Submit

September 13, 2017

Conditions

Cardiovascular Disease

Keywords

cardiovascular diseaseeducationpeer mentor

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

lifestyle counseling

EXPERIMENTAL

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

Interventions

Educational InterventionBEHAVIORAL

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.

lifestyle counseling

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All criteria must be met to be eligible
  • Employees (Men \& Women) above the age of 35 years.
  • permanent employees with at least 6 months for retirement.
  • Willing to provide Informed Consent.

You may not qualify if:

  • Subject ineligible if even one criterion is met
  • Pregnant or intent to get pregnant in one year.
  • Inability to attend follow up visits.
  • Any active malignancy or known malignancy on treatment.
  • Will relocate during the study period.
  • Unwilling or unable to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Appollo Ispat Complex Ltd

Dhaka, Bangladesh

Location

Shardharan Bima Coorporation

Dhaka, Bangladesh

Location

Bharat Heavy Electrical Limited

Bangalore, India

Location

TVS Motor company Limited

Hosūr, India

Location

Department of Census & Statistics

Colombo, Sri Lanka

Location

Sri Lanka Telecom

Colombo, Sri Lanka

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Dr Denis Xavier, M.D,MSc.

    St.John's Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 17, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

September 14, 2017

Record last verified: 2016-10

Locations

IN(2)SR(2)BA(2)