Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
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|ClinicalTrials.gov Identifier: NCT00608387|
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Diabetes Mellitus, Type 2 Hypertension Obesity Tobacco Use Cessation||Behavioral: Chronic disease management Web-based software||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2012|
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.
Other Name: CliniPro
No Intervention: B
Participants will receive usual care from their healthcare providers.
- Glycosylated hemoglobin (HbgA1c) [ Time Frame: Measured at Year 3 ]
- Mean blood pressure [ Time Frame: Measured at Year 3 ]
- Low-density lipoprotein cholesterol (LDL) [ Time Frame: Measured at Year 3 ]
- BMI [ Time Frame: Measured at Year 3 ]
- Smoking status [ Time Frame: Measured at Year 3 ]
- Overall cost-effectiveness [ Time Frame: Measured at Year 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608387
|United States, South Dakota|
|Black Hills Center for American Indian Health|
|Rapid City, South Dakota, United States, 57701|
|Principal Investigator:||Jeffrey A. Henderson, MD, MPH||Black Hills Center for American Indian Health|