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Simplified cardiovascular management study

Simplified Cardiovascular Management (SimCard) Study â?? A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in India - SIMCARD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002762
Enrollment
2400
Registered
2012-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- â?¢ History of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or Diabetes mellitus Health Condition 2: I63- Cerebral infarction Health Condition 3: I259- Chronic ischemic heart disease, unspecified Health Condition 4: I10- Essential (primary) hypertension Health Condition 5: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Simplified Cardiovascular management programme: Villages in the control group will continue their usual practices while villages in the intervention group will receive the following int
2) simplify guideline-based CVD prevention and management schemes to suit local situations, emphasizing the importance of patient identification, referral, regular follow-up and a â??2+2â??model: 2 th
3) enhance the capacity of local CHWs in CVD prevention and management through systematic training
4) ensure the effectiveness of training through healthcare system strengthening that integrate township PCPs, EDS, performance feedback to CHWs and performance-based payment
5) being flexible and adaptive to incorporate insights gained from process evaluation and program implementation
and 6) enlist the help of government officials in implementing the management schemes
we do not anticipate any problem in obtaining such support owing to our rapport in working with them before. Control Intervention1: Usual practice: Villages in the control group will continue thei

Sponsors

National Heart Lung and Blood Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 12 months

Secondary

MeasureTime frame
â?¢ The net difference in mean post-intervention blood pressure changes of high-risk patients from baseline between intervention and control villages; â?¢ The proportion of high-risk individuals aware of the harms of smoking or high-salt diet; â?¢ The proportion of high-risk individuals treated with aspirin; â?¢ The proportion of high-risk individuals receiving 5 or more follow-up visits in a year; â?¢ Hypertension awareness, treatment, and control rates. Timepoint: 12 months

Countries

China, India

Contacts

Public ContactDr Vamadevan S Ajay

Public Health Foundation of India

ajay@ccdcindia.org91-11-26850117

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026