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Simplified Cardiovascular Management Study (SimCard)

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ClinicalTrials.gov Identifier: NCT01503814
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE December 30, 2011
First Posted Date  ICMJE January 4, 2012
Last Update Posted Date May 16, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simplified Cardiovascular Management Study
Official Title  ICMJE Simplified Cardiovascular Management Study: A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in Tibet, China and Haryana, India
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE 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)

Study Arms  ICMJE
  • No Intervention: Control (Usual Care)
    Control
  • 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
    Intervention: Other: Simplified cardiovascular disease management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2014)
2086
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2012)
1000
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01503814
Other Study ID Numbers  ICMJE 03COE-RA02
HHSN268200900027C ( Other Grant/Funding Number: NHLBI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lijing Yan, PhD The George Institute, China (Beijing, CN)
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP