The effect of a community-based programme for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: A cluster randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,600
- 试验地点
- 1
- 主要终点
- Reduction in stroke mortality
研究概览
简要总结
With epidemiological transition, stroke is emerging as an important cause of death and disability in rural India and perpetuates poverty. Community-based interventions that controlled cardiovascular risk factors using well-established medications and lifestyle changes have reduced stroke mortality in developed countries. However, well tested community-based interventions to reduce the stroke mortality in rural areas of India as well as other developing countries are lacking. Stroke mortality in such areas can be potentially reduced in a cost effective manner by using simple guideline-based treatments of cardiovascular risk factors using generic medicines and increasing awareness about stroke. However, delivering such a care in rural areas where there is minimal awareness about stroke and its risk factors, economic resources are limited and healthcare for these problems in not easily available is logistically challenging.
This study aims to address these challenges. In this cluster randomized, parallel group, two arm trial we will assess the effect of a healthcare delivery intervention package to control cardiovascular risk factors on stroke mortality. The study will be conducted in an underdeveloped rural area of central India. Thirty two villages will be randomly assigned to the intervention arm and will receive the healthcare delivery intervention while other 32 villages will be assigned to the control arm and will receive enhanced usual care in the form of health education on harmful effects of tobacco at the beginning and at the end of the intervention. The intervention will last for 3.5 years. The intervention will be jointly delivered by a village-based community health worker and a visiting outreach physician. It is a “3 plus 3†intervention in which the outreach physician will provide medical treatment for 3 conditions-hypertension, diabetes and secondary prophylaxis of stroke while the community health worker will provide lifestyle modification counseling to reduce 3 risk factors- salt, tobacco and alcohol use. In the intervention area all the individuals 50 years of age and above will be screened for hypertension, glycosuria and stroke by a village health worker at the beginning of the intervention. These patients will be evaluated by an outreach physician who will confirm the diagnoses and provide guideline-based medical treatment and follow up. The community health workers will follow these patients to promote medication compliance and provide lifestyle modification advice for reducing the risk factors discussed above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Cluster level: Inclusion criteria: The village 1.should belong to the field practice area of SEARCH in Gadchiroli district 2.should have population >400 Individual level: The individual should.
- •1.be a resident of the village 2.be 50 years of age or older 3.provide written, informed consent to receive the intervention and with ANY of the conditions listed below to receive treatment and follow up under the intervention 4.with a mean systolic blood pressure of 140 mm Hg or above and mean diastolic blood pressure of 90 mm Hg or above (based on 2 separate readings taken 5 minutes apart) or with a diagnosis of hypertension and on antihypertensive medications, 5.with glycosuria detected using urine dipsticks during screening and random capillary blood glucose of 200 mg/dl or above; or those with outside records showing fasting plasma glucose 126 mg/dL or above or single random plasma blood glucose value of 200 mg/dL or above ; or previous diagnosis of diabetes and taking treatment for diabetes 6.with diagnosis of stroke defined using the World Health Organization’s definition as a focal (or at times global) neurological impairment of sudden onset, and lasting > 24 hours (or leading to death), and of presumed vascular origin.
排除标准
- •Cluster level: 1.villages within 5 km distance from Gadchiroli town (district place) Individual level: 1.terminally ill patients 2.patients with cardiovascular or kidney disease that can not be managed in primary care setting.
结局指标
主要结局
Reduction in stroke mortality
时间窗: last 2.5 years of the intervention
次要结局
- Reduction in all-cause mortality(last 2.5 years of the intervention)
- Reduction in cardiovascular mortality(last 2.5 years of the intervention)
- Number of individuals with hypertension taking antihypertensive medications(at baseline and at the end of 3.5 years of the intervention)
- Blood pressure reduction in the intervention arm(at baseline and at the end of 3.5 years of the intervention)
- Number of diabetic patients who have random capillary blood glucose of 200mg/dl or less in the intervention arm(at baseline and at the end of 3.5 years of the intervention)
- Awareness about stroke and its risk factors (Which body organ is affected in stroke? Which diseases or factors increase the risk of stroke?)(at baseline and at the end of 3.5 years of the intervention)