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
试验速览
- 阶段
- 不适用
- 入组人数
- 334
- 试验地点
- 6
- 主要终点
- Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)
研究概览
简要总结
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).
详细描述
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 -
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Educational Intervention (Behavioral)
结局指标
主要结局
Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)
时间窗: 3 Months
validated non lab based Cardiovascular risk score will be used (developed from NHANES data and validated against Framingham score
Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)
时间窗: 1 Month
A knowledge, attitudes \& practices questionnaire will be administered to participants
Identification of barriers and facilitators for an optimal Cardiovascular Health environment. (In depth interviews and focus groups discussions with random sample of participants)
时间窗: 3 Months
qualitative analysis - In depth interviews and focus groups discussions with random sample of participants
次要结局
未报告次要终点