Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
Primary Purpose
Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic disease management Web-based software
Sponsored by

About this trial
This is an interventional supportive care trial for Cardiovascular Diseases
Eligibility 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
Sites / Locations
- Black Hills Center for American Indian Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
Participants will receive usual care from their healthcare providers and have access to a Web-based CVD risk-factor management program.
Participants will receive usual care from their healthcare providers.
Outcomes
Primary Outcome Measures
Glycosylated hemoglobin (HbgA1c)
Secondary Outcome Measures
Mean blood pressure
Low-density lipoprotein cholesterol (LDL)
BMI
Smoking status
Overall cost-effectiveness
Full Information
NCT ID
NCT00608387
First Posted
January 7, 2008
Last Updated
June 3, 2014
Sponsor
Black Hills Center for American Indian Health
Collaborators
University of Washington, University of Colorado, Denver, NuMedics, Inc., Cheyenne River Sioux Tribe Telephone Authority, Missouri Breaks Industries Research, Inc., Cheyenne River Sioux Tribe
1. Study Identification
Unique Protocol Identification Number
NCT00608387
Brief Title
Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
Official Title
Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Black Hills Center for American Indian Health
Collaborators
University of Washington, University of Colorado, Denver, NuMedics, Inc., Cheyenne River Sioux Tribe Telephone Authority, Missouri Breaks Industries Research, Inc., Cheyenne River Sioux Tribe
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension, Obesity, Tobacco Use Cessation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Participants will receive usual care from their healthcare providers and have access to a Web-based CVD risk-factor management program.
Arm Title
B
Arm Type
No Intervention
Arm Description
Participants will receive usual care from their healthcare providers.
Intervention Type
Behavioral
Intervention Name(s)
Chronic disease management Web-based software
Other Intervention Name(s)
CliniPro
Intervention Description
Participants will have access to remotely based medical providers through the use of the Web-based software.
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin (HbgA1c)
Time Frame
Measured at Year 3
Secondary Outcome Measure Information:
Title
Mean blood pressure
Time Frame
Measured at Year 3
Title
Low-density lipoprotein cholesterol (LDL)
Time Frame
Measured at Year 3
Title
BMI
Time Frame
Measured at Year 3
Title
Smoking status
Time Frame
Measured at Year 3
Title
Overall cost-effectiveness
Time Frame
Measured at Year 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Henderson, MD, MPH
Organizational Affiliation
Black Hills Center for American Indian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Hills Center for American Indian Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15565762
Citation
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.
Results Reference
background
PubMed Identifier
15142919
Citation
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.
Results Reference
background
PubMed Identifier
14513667
Citation
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.
Results Reference
background
PubMed Identifier
23001642
Citation
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.
Results Reference
background
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Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
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