Simplified Cardiovascular Management Study (SimCard)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The George Institute for Global Health, China
ClinicalTrials.gov Identifier:
NCT01503814
First received: December 30, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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 Intervention
Cardiovascular Disease
Other: Simplified cardiovascular disease management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The George Institute for Global Health, China:

Primary Outcome Measures:
  • Net Difference in Proportion Treated with Low-dose Diuretics [ Time Frame: baseline and at one year ] [ Designated as safety issue: No ]
    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:
  • Net Difference from Baseline in Mean Blood Pressure [ Time Frame: baseline and at one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 2086
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)


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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503814

Locations
China, Tibet
Linzhou
Lhasa, Tibet, China
Gongbujiangda
Linzhi, Tibet, China
India
Faridabad
Haryana, India
Sponsors and Collaborators
The George Institute for Global Health, China
Investigators
Principal Investigator: Lijing Yan, PhD The George Institute, China (Beijing, CN)
  More Information

Publications:
Responsible Party: The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT01503814     History of Changes
Other Study ID Numbers: 03COE-RA02, HHSN268200900027C
Study First Received: December 30, 2011
Last Updated: August 25, 2014
Health Authority: China: Ethics Committee
United States: Institutional Review Board

Keywords provided by The George Institute for Global Health, China:
hypertension
primary care
cardiovascular disease prevention
high cardiovascular risk
diuretics
aspirin
smoking cessation
salt reduction
Tibet

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014