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

Cardiovascular Disease Clinical Trial

— PROGRESS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02388542
• Other study ID #: PROGRESS-IND-1022015
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2015
• Last updated: September 13, 2017
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: St. John's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 334
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
St. John's Research Institute	International Centre for Diarrhoeal Disease Research, Bangladesh, University of Colombo, University of Oxford

Countries where clinical trial is conducted

Bangladesh,  India,  Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)	A knowledge, attitudes & practices questionnaire will be administered to participants	1 Month
Primary	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
Primary	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