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

Not Applicable

Completed

• Conditions: Obesity; Hypertension; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Tobacco Use Cessation
• Interventions: Behavioral: Chronic disease management Web-based software

• Registration Number: NCT00608387
• Lead Sponsor: Black Hills Center for American Indian Health

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-06
• Study Start: 2009-02
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Chronic disease management Web-based software	Participants will receive usual care from their healthcare providers and have access to a Web-based CVD risk-factor management program.

Primary Outcome Measures

Name	Time	Method
Glycosylated hemoglobin (HbgA1c)	Measured at Year 3

Secondary Outcome Measures

Name	Time	Method
Mean blood pressure	Measured at Year 3
Overall cost-effectiveness	Measured at Year 3
Low-density lipoprotein cholesterol (LDL)	Measured at Year 3
BMI	Measured at Year 3
Smoking status	Measured at Year 3

Trial Locations

Locations (1)

Black Hills Center for American Indian Health; 🇺🇸 Rapid City, South Dakota, United States