Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians - Full Text View

Purpose

Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have been few behaviorally based programs to lessen CVD risk among this population. The purpose of this study is to evaluate whether a Web-based program, in addition to usual medical care, can lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of developing CVD.

Condition	Intervention
Cardiovascular Diseases Diabetes Mellitus, Type 2 Hypertension Obesity Tobacco Use Cessation	Behavioral: Chronic disease management Web-based software

MedlinePlus related topics:

Diabetes High Blood Pressure Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Official Title:	Web-Based, Patient-Centered Approach to CVD Risk-Factor Management and Reduction

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

Primary Outcome Measures:

Glycosylated hemoglobin (HbgA1c) [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean blood pressure [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
Low-density lipoprotein cholesterol (LDL) [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
BMI [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
Smoking status [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
Overall cost-effectiveness [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Participants will receive usual care from their healthcare providers and have access to a Web-based CVD risk-factor management program.	Behavioral: Chronic disease management Web-based software Participants will have access to remotely based medical providers through the use of the Web-based software.
B: No Intervention Participants will receive usual care from their healthcare providers.

Detailed Description:

Cardiovascular disease (CVD) is a leading cause of death among American Indians. Significant risk factors for CVD within the American Indian population include type 2 diabetes, tobacco use, poor dietary and physical activity habits, and poor medication and treatment adherence. Despite the fact that these risk factors can be reduced through behavior change, there have been few behaviorally based interventions aimed at American Indians to lessen their CVD risk. Research has shown that medical care is moving away from sporadic, standard doctors' office visits to a more continuous and interactive relationship with health care providers. A Web-based program that allows people to interact with remotely located doctors who can answer questions and provide advice may be beneficial at increasing treatment adherence and lowering CVD risk. This study will evaluate the use of a Web-based program at lowering CVD risk among American Indians with type 2 diabetes. Researchers will also analyze the cost-effectiveness of the Web-based program and the possible healthcare cost savings.

This 3-year study will enroll American Indian adults at high risk for CVD. Participants will be randomly assigned either to usual care at their local health facility or usual care plus the Web-based program. Participants using the Web-based program will have access to a Web site that will allow them to interact with two remotely based doctors. Participants will be able to send e-mail and instant messages to ask questions and receive information, advice, or motivational messages from the doctors. Participants will periodically enter their blood glucose test results and complete questionnaires online. Study visits, occurring twice a year for 3 years, will include blood pressure and body mass index (BMI) measurements, blood collection, and smoking status assessments.

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completed a baseline Education and Research Towards Health (EARTH) study examination
Diagnosed with type 2 diabetes mellitus AND hypertension and/or hyperlipidemia
Able to read and understand English
Able to walk

Exclusion Criteria:

Diagnosed with CVD at study entry
Currently receiving active treatment for any non-skin cell cancer
Any medical condition that study physicians believe would interfere with study participation or evaluation of results
Mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with, the study procedures
Kidney insufficiency, as indicated by serum creatinine level greater than 2.0 mg/dL for women and greater than 2.4 mg/dL for men
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608387

Contacts


Contact: Jeffrey A. Henderson, MD, MPH	605-348-6100	jhenderson@bhcaih.org

Locations


United States, South Dakota
	Black Hills Center for American Indian Health
	Rapid City, South Dakota, United States, 57701

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

University of Washington

University of Colorado at Denver and Health Sciences Center

NuMedics, Inc.

Cheyenne River Sioux Tribe Telephone Authority

Cheyenne River Sioux Tribe

Investigators


Principal Investigator:	Jeffrey A. Henderson, MD, MPH	Black Hills Center for American Indian Health

More Information

Publications:

Goldberg HI, Lessler DS, Mertens K, Eytan TA, Cheadle AD. Self-management support in a web-based medical record: a pilot randomized controlled trial. Jt Comm J Qual Saf. 2004 Nov;30(11):629-35, 589.

Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159.

Goldberg HI, Ralston JD, Hirsch IB, Hoath JI, Ahmed KI. Using an Internet comanagement module to improve the quality of chronic disease care. Jt Comm J Qual Saf. 2003 Sep;29(9):443-51.

Responsible Party:	Black Hills Center for American Indian Health ( Jeffrey A. Henderson, MD, MPH )
Study ID Numbers:	453, 1 U01 HL087422
First Received:	January 7, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00608387
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Diabetes Mellitus

Vascular Diseases

Endocrine System Diseases

Overweight

Body Weight

Signs and Symptoms

Diabetes Mellitus, Type 2

Nutrition Disorders

Overnutrition

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 03, 2008

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) University of Washington University of Colorado at Denver and Health Sciences Center NuMedics, Inc. Cheyenne River Sioux Tribe Telephone Authority Cheyenne River Sioux Tribe
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00608387