Improving Coronary Prevention in a County Health System

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00128687
First received: August 8, 2005
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program , a case management approach, can be effectively used to manage the risk of coronary artery disease.


Condition Intervention
Cardiovascular Diseases
Coronary Disease
Coronary Heart Disease Risk Reduction
Heart Diseases
Behavioral: risk reduction

Study Type: Interventional
Study Design: Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Evidence from extensive population studies and clinical trials shows the effectiveness of risk factor management in reducing morbidity and mortality from coronary artery disease (CAD). These studies have generated important national clinical practice guidelines. Current prevention practices, however, fall short of attaining the goals recommended in these national guidelines. These shortfalls lead to unnecessary CAD disease burden, as well as perpetuation of socioeconomic disparities. Case management proves to augment current CAD prevention activities and improve adherence with national guidelines. The Stanford Health Education and Risk Reduction Training (HEAR2T) program is an innovative, yet well-tested, case management tool which will be evaluated in this study. HEAR2T has been developed and evaluated in several studies at Stanford. It is based upon the social cognitive model of Bandura and uses case managers to work intensely with patients to educate them and change their overall behavior related to health.

DESIGN NARRATIVE:

The Stanford Health Education and Risk Reduction Training (HEAR2T) program will be evaluated in a high-risk population of low socioeconomic status (SES) served by the county health care system of San Mateo County (SMC), California. The study will: 1) enhance the HEAR2T program for use in low-SES populations; 2) implement this program as an integral part of clinical care; 3) implement a randomized controlled trial to evaluate the effectiveness of HEAR2T in lowering aggregate CAD risk; 4) determine if HEAR2T diminishes socioeconomic disparities; 5) estimate HEAR2T's cost effectiveness; and 6) transition the intervention from a research study to an ongoing County CAD case management program. The primary outcome measure will be change in aggregate CAD risk score, calculated from a Framingham model based on individual CAD risk factors. The primary hypothesis is that patients case-management via the HEAR2T model will produce favorable changes in aggregate CAD risk score compared to control patients in usual care. An estimated 200 intervention and 200 usual care patients will be enrolled from four health centers in the SMC system. Usual care patients will crossover to the intervention after 15 months, allowing for additional assessment of the intervention's impact. Continued follow-up of the participants will assess the durability of risk changes achieved during initial intensive case-management. This study will make a critical and innovative contribution to defining optimal disease management in a low-SES population.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128687

Sponsors and Collaborators
Investigators
Investigator: Randall Stafford Stanford University
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128687     History of Changes
Other Study ID Numbers: 240
Study First Received: August 8, 2005
Last Updated: April 22, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013