Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Black Hills Center for American Indian Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: A
Participants will receive usual care from their healthcare providers and have access to a Web-based CVD risk-factor management program.
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Participants will have access to remotely based medical providers through the use of the Web-based software.
Other Names:
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No Intervention: B
Participants will receive usual care from their healthcare providers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Glycosylated hemoglobin (HbgA1c)
Time Frame: Measured at Year 3
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Measured at Year 3
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Mean blood pressure
Time Frame: Measured at Year 3
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Measured at Year 3
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Low-density lipoprotein cholesterol (LDL)
Time Frame: Measured at Year 3
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Measured at Year 3
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BMI
Time Frame: Measured at Year 3
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Measured at Year 3
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Smoking status
Time Frame: Measured at Year 3
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Measured at Year 3
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Overall cost-effectiveness
Time Frame: Measured at Year 3
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Measured at Year 3
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeffrey A. Henderson, MD, MPH, Black Hills Center for American Indian Health
Publications and helpful links
General Publications
- Goldberg HI, Ralston JD, Hirsch IB, Hoath JI, Ahmed KI. Using an Internet comanagement module to improve the quality of chronic disease care. Jt Comm J Qual Saf. 2003 Sep;29(9):443-51. doi: 10.1016/s1549-3741(03)29053-5.
- Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159. doi: 10.1136/bmj.328.7449.1159.
- Goldberg HI, Lessler DS, Mertens K, Eytan TA, Cheadle AD. Self-management support in a web-based medical record: a pilot randomized controlled trial. Jt Comm J Qual Saf. 2004 Nov;30(11):629-35, 589. doi: 10.1016/s1549-3741(04)30074-2.
- Henderson JA, Chubak J, O'Connell J, Ramos MC, Jensen J, Jobe JB; LOWPK Project Team. Design of a randomized controlled trial of a web-based intervention to reduce cardiovascular disease risk factors among remote reservation-dwelling American Indian adults with type 2 diabetes. J Prim Prev. 2012 Aug;33(4):209-22. doi: 10.1007/s10935-012-0276-x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 453
- 1U01HL087422 (U.S. NIH Grant/Contract)
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