Viewing Study NCT02388542



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Last Modification Date: 2024-10-26 @ 11:39 AM
Study NCT ID: NCT02388542
Status: UNKNOWN
Last Update Posted: 2017-09-14
First Post: 2015-02-09

Brief Title: Effect of Peer-mentor Mediated Interventions on Cardiovascular Risk Factors at Worksites
Sponsor: St Johns Research Institute
Organization: St Johns Research Institute

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2016-10
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PROGRESS
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 diseaseCVD 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None