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A scientific trial to determine the effect of risk-related information on awareness, behavior and change in risk of heart disease among people having hypertension, diabetes, or other heart-disease causing risky behavior.

Effect of risk communication methods on risk perception, CVD risk status and risk behaviours among patients with HTN, DM-II and CVD behavioural risk factors.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028614
Enrollment
183
Registered
2020-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Risk communication: Risk communication using Framingham Risk score. Intervention2: Risk communication: Risk communication using heart age. Control Intervention1: Usual care: Usual care

Sponsors

AIIMS BHOPAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. More than 30 years of age. 2. Reside in Bhopal for >6months. 3. Presence of any of the 4 CVD behavioral risk factors (tobacco use, alcohol use, physical inactivity and unhealthy diet); OR already diagnosed with hypertension or diabetes mellitus or both.

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis CAD/IHD/STROKE (verified through written medical prescription or self-reported angiography, DSA, stent, by-pass, etc.) 2. Previous diagnosis of congenital heart diseases (verified through written medical prescription or self-reported frequent pneumonia, blue discoloration, etc.) 3. Previous diagnosis of RHD, valve diseases (verified through written medical prescription or self-reported frequent painful injections, etc.)

Design outcomes

Primary

MeasureTime frame
10-year risk of CVDTimepoint: change in 10-year risk of CVD over 1 year

Secondary

MeasureTime frame
Risk perception, medication adherence ,presence of behavioral risk factor(s) ,adherence to annual screening for complications, hospital visits ,healthcare provider switch behavior, cost of careTimepoint: change after 12 months except risk perception which will be assessed every 3 months for 1 year.

Countries

India

Contacts

Public ContactDr Kritika Singhal

All India Institute of Medical Sciences

sanjeev.CFM@aiimsbhopal.edu.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026