Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
Recruitment status was Active, not recruiting
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction |
- Glycosylated hemoglobin (HbgA1c) [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
- 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: | February 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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.
|
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: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
More Information
Publications:
| Responsible Party: | Jeffrey A. Henderson, MD, MPH, Black Hills Center for American Indian Health |
| ClinicalTrials.gov Identifier: | NCT00608387 History of Changes |
| Other Study ID Numbers: | 453, 1 U01 HL087422 |
| Study First Received: | January 7, 2008 |
| Last Updated: | April 18, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Hypertension Obesity Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Vascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013