We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Simplified Cardiovascular Management Study (SimCard)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01503814
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
The goal of this study is to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management for application in resource-scarce settings. The study aims to assess the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers (PCPs) or community health workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes in resource-scarce Tibet, China and Haryana India.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: Simplified cardiovascular disease management Not Applicable

Detailed Description:

Cardiovascular disease (CVD) is the leading cause of morbidity, mortality, and disability in not only developed, but also developing countries. There are well-established interventions such as lifestyle modification and drug therapies, i.e., aspirin and low-dose diuretics, that along with their consistent use, can help alleviate these burdens if the practicalities of how to deliver such care to large numbers in resource-poor settings at low cost can be resolved. One particular cost-effective approach for secondary prevention of CVD is to identify and manage individuals at high CVD risk in order to prevent or delay events. This approach has been tested in the rural Andhra Pradesh Cardiovascular Prevention Study in India and is currently being implemented in rural areas of northern China in the China Rural Health Initiative funded by NHLBI.

This project aims to address the highly prevalent problem of CVD in even more remote and poor areas of China and India that have received only minimal attention so far, specifically Tibet, China and Haryana, India. This pilot project will be a cluster-randomized controlled interventional trial that will include a total of 15 villages in 6 townships in Gongbujiangda County and 12 villages in 6 townships in Linzhou County in Tibet, China and 12 villages in the state of Haryana in India. The study will last for one year. The villages will be randomized to receive either the intervention package or usual care. At baseline, village-wide screenings will be done to identify high-risk individuals in the selected villages who will then be followed throughout the study to about one year.

The interventional model will make use of a highly simplified cardiovascular disease management plan targeting lifestyle modification and utilization of basic drug regimens to help overcome the barriers in prevention and management of CVD in these areas with extremely limited economic and natural resources, minimal public awareness to the problem, and a lack of trained healthcare professionals.

Electronic blood pressure monitors will be used in all villages to measure the blood pressures of these individuals. However accuracy of the electronic blood pressure monitor measurements needs to be considered due to Tibet's high altitude. A study to validate and calibrate the selected blood pressure monitor model in both plains and high altitude areas will thus be undertaken using the validation procedure published by the European Society of Hypertension (ESH) to ensure accuracy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2086 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Simplified Cardiovascular Management Study: A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in Tibet, China and Haryana, India
Study Start Date : January 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2015

Arm Intervention/treatment
No Intervention: Control (Usual Care)
Experimental: Intervention
Use of a simplified guideline-based CVD prevention and management scheme by village doctors targeting high risk individuals focusing on a"2+2"model: 2 therapeutic lifestyle recommendations (smoking cessation and salt consumption reduction) plus prescription of 2 low-cost drugs (aspirin and low-dose diuretics) when applicable
Other: Simplified cardiovascular disease management

This study is a complex pragmatic trial.The intervention includes a "package" of 4 main established measures for cardiovascular prevention and management:

2 therapeutic lifestyle recommendations- smoking cessation (if applicable) and reduced salt consumption

2 drug therapies (if applicable)- hydrochlorothiazide, 25mg tab, 1/2 tab daily (12.5mg/day) and aspirin, 25mg tab, 3 tabs daily (75mg/day)

Primary Outcome Measures :
  1. Net Difference in Proportion Treated with Low-dose Diuretics [ Time Frame: baseline and at one year ]
    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. The outcome measure will be assessed via a questionnaire that will ask about low-dose diuretics usage that will be administered at baseline and then again following the intervention period at around one year.

Secondary Outcome Measures :
  1. Net Difference from Baseline in Mean Blood Pressure [ Time Frame: baseline and at one year ]
    The net difference in mean post-intervention blood pressure changes of high-risk patients from baseline between intervention and control villages will be measured. This outcome measure will be taken at baseline and then again following the intervention period at around one year using a standardized electronic blood pressure monitor. Each subject's blood pressure will be taken twice at different time points within the same visit for the baseline measurement and one year follow-up measurement.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Age is equal or older than 40 years old AND the subject has a self-reported history of ANY of the following diseases:

  • CVD OR
  • Diabetes OR
  • Stroke (including both Ischemic Stroke and Haemorrhagic Stroke) OR
  • Measured systolic blood pressure is equal or greater than 160mmHg at two different time points in the same day during the baseline survey.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503814

Layout table for location information
China, Tibet
Lhasa, Tibet, China
Linzhi, Tibet, China
Haryana, India
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Layout table for investigator information
Principal Investigator: Lijing Yan, PhD The George Institute, China (Beijing, CN)
World Health Organization. Global strategy on diet, physical activity and health, F.-S.W.H. Assembly, Editor. 2004: Available from: http://www.who.int/dietphysicalactivity/goals/en/index.html.
Murray C, and Lopez A. The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability from Disease, Injuries and Risk Factors in 1990 and Projected to 2020. Boston, Mass: Harvard School of Public Health., 1996.
China guideline of hypertension updated 2005 Progression in the diagnosis and management of hypertension. China Hypertension League, 2005.
Li SS, Zhao XS, Ba S, He F, Ke L, Li N, Yan LL, Wu YF. (2009, November). Validation of electronic sphygmomanometers against mercury sphygmomanometers at high altitude in Tibet. Poster presented at The Word Hypertension Congress 2009.
National Vascular Disease Prevention Alliance, Guidelines for the Assessment of Absolute Cardiovascular Disease Risk. 2009, National Heart Foundation of Australia: Melbourne.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01503814    
Other Study ID Numbers: 03COE-RA02
HHSN268200900027C ( Other Grant/Funding Number: NHLBI )
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: August 2014
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
primary care
cardiovascular disease prevention
high cardiovascular risk
smoking cessation
salt reduction
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases