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

Study Overview
=================
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.

Official Title
-----------------
Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction

Conditions
-----------------
Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension, Obesity, Tobacco Use Cessation

Intervention / Treatment
-----------------
* Behavioral: Chronic disease management Web-based software


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* Participants will have access to remotely based medical providers through the use of the Web-based software.<br>* Other names: CliniPro;|
| No Intervention: B<br>Participants will receive usual care from their healthcare providers. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin (HbgA1c) |  | Measured at Year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood pressure |  | Measured at Year 3 | 
| Low-density lipoprotein cholesterol (LDL) |  | Measured at Year 3 | 
| BMI |  | Measured at Year 3 | 
| Smoking status |  | Measured at Year 3 | 
| Overall cost-effectiveness |  | Measured at Year 3 |