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

This study has been completed.
Sponsor:
Collaborators:
University of Washington
University of Colorado, Denver
NuMedics, Inc.
Cheyenne River Sioux Tribe Telephone Authority
Missouri Breaks Research Industries, Inc.
Cheyenne River Sioux Tribe
Information provided by (Responsible Party):
Jeffrey Henderson, MD, MPH, Black Hills Center for American Indian Health
ClinicalTrials.gov Identifier:
NCT00608387
First received: January 7, 2008
Last updated: June 3, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Black Hills Center for American Indian Health:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbgA1c) [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 149
Study Start Date: February 2009
Study Completion Date: June 2012
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608387

Locations
United States, South Dakota
Black Hills Center for American Indian Health
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
Black Hills Center for American Indian Health
University of Washington
University of Colorado, Denver
NuMedics, Inc.
Cheyenne River Sioux Tribe Telephone Authority
Missouri Breaks Research Industries, Inc.
Cheyenne River Sioux Tribe
Investigators
Principal Investigator: Jeffrey A. Henderson, MD, MPH Black Hills Center for American Indian Health
  More Information

Publications:
Responsible Party: Jeffrey Henderson, MD, MPH, President & CEO, 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: June 3, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Obesity
Tobacco Use Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014