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Completed

NCT Number: NCT00608387

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chronic disease management Web-based software

Behavioral

Participants will have access to remotely based medical providers through the use of the Web-based software.

Other names: CliniPro

Primary outcomes

  1. Glycosylated hemoglobin (HbgA1c)

    Time frame: Measured at Year 3

Secondary outcomes

  1. Mean blood pressure

    Time frame: Measured at Year 3

  2. Low-density lipoprotein cholesterol (LDL)

    Time frame: Measured at Year 3

  3. BMI

    Time frame: Measured at Year 3

  4. Smoking status

    Time frame: Measured at Year 3

  5. Overall cost-effectiveness

    Time frame: Measured at Year 3

Sponsors and collaborators

Lead sponsor

Black Hills Center for American Indian Health

Other

Collaborators

  • Cheyenne River Sioux Tribe
  • Cheyenne River Sioux Tribe Telephone Authority
  • Missouri Breaks Industries Research, Inc.
  • NuMedics, Inc.
  • University of Colorado, Denver
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 6, 2008
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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