Clinical trial NCT02388542: Effect of Peer-mentor Mediated Interventions on Cardiovascular Risk Factors at Worksites
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Keywords: cardiovascular disease
education
peer mentor
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: University of Colombo
name: University of Oxford
First posted: 2015-03-17
Enrollment: 334
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)
timeFrame: 1 Month
measure: Identification of barriers and facilitators for an optimal Cardiovascular Health environment. (In depth interviews and focus groups discussions with random sample of participants)
timeFrame: 3 Months
measure: Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Appollo Ispat Complex Ltd
city: Dhaka
country: Bangladesh
facility: Shardharan Bima Coorporation
city: Bangalore
country: India
facility: Bharat Heavy Electrical Limited
city: Hosur
country: India
facility: TVS Motor company Limited
city: Colombo
country: Sri Lanka
facility: Department of Census & Statistics
city: Colombo
country: Sri Lanka
facility: Sri Lanka Telecom
Study officials:
affiliation: St.John's Medical College
name: Dr Denis Xavier, M.D,MSc.
role: PRINCIPAL_INVESTIGATOR
References: