Simplified cardiovascular management study

Completed

• Conditions: Cerebral infarction, (2) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, (3) ICD-10 Condition: I10||Essential (primary) hypertension, (4) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,

• Registration Number: CTRI/2012/07/002762
• Lead Sponsor: National Heart Lung and Blood Institute

Brief Summary

The **overall goal** of the present proposal is to develop, pilot test, and evaluate a highly simplified butguideline-based program for cardiovascular management in resource-scarcesettings.The **specificaim** is to evaluate the effects of implementing a simple low-cost cardiovascular management programfor high-risk individuals, delivered by primary careproviders andcommunity healthcare workers (CHWs), on the proportion of patientsappropriately treated with diuretics as well as a number of secondary outcomes.  The main features of the **simplified cardiovascular managementprogram** include: 1) focus on high-risk for maximal cost-effectiveness; 2)simplified yet evidence-based measures; 3) systematic training of CHWs; 4)healthcare system strengthening with electronic decision support andperformance feedback and payment; 5) adaptive interventional design; and 6)local government support.

Building on our prior experiences, theGeorge Institute for Global Health, China in collaborations with the PublicHealth Foundation of India with cross-fertilizationof ideas and expertise proposes to conduct **a cluster-randomized controlled interventional pilot trial**in the rural areas in Tibet, Chinaand Haryana, India.  In each country, 12villages will be selected to be randomized to receive the intervention (6villages) or usual care (6 villages). Before the intervention begins, avillage-wide screening will be done to identify and measure high-riskindividuals in all villages. The intervention will be one year long.  A post-intervention assessment of allhigh-risk individuals will also be conducted. Process evaluation, economicevaluation, and verbal autopsy represent important aspects of the evaluationmatrix. The results of the studyare expected to both advance scientific knowledge to prepare for futurelarge-scale studies and to provide translational evidence necessary for soundpolicy making to address the CVD problem in resource-scarce settings.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-07
• Study Completion: 2014-03-31
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

• All participants above the age of 40 years will be approached to participate regardless of gender, ethnic group, denomination, or other factors to assess their cardiovascular risk status.From this group subjects having elevated cardiovascular risk will be eligible for enrollment in study. High cardiovascular risk will be defined as: •History of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or •Older age.
• 40 years or older and having diabetes mellitus, or •Older age (40 years or more) and systolic blood pressure more than 160 mmHg on two occasions at least one day apart.

Exclusion Criteria

• The research proposes to study adults at high risk for cardiovascular disease, and excludes adults below the age of 40 years.
• Additional exclusions are: •Subjects with cardiovascular diseases complications whom cannot be managed at primary care settings •Subjects having Malignancy or life-threatening diseases; •Bed-ridden subjects; •Currently participating in a clinical trial;and •Subjects having plans to move in the next 1 year.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the net differences between the changes in the proportion of high-risk individuals treated with low-dose diuretics pre-and-post intervention between intervention and control villages.	12 months

Secondary Outcome Measures

Name	Time	Method
•The net difference in mean post-intervention blood pressure changes of high-risk patients from baseline between intervention and control villages;	•The proportion of high-risk individuals aware of the harms of smoking or high-salt diet;

Trial Locations

Locations (1)

Ballabgarh; 🇮🇳 Faridabad, HARYANA, India

Ballabgarh

🇮🇳Faridabad, HARYANA, India

Vamadevan S Ajay

Principal investigator

11-43421966

ajay@ccdcindia.org