Clinical trial NCT00608387: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Diabetes Mellitus, Type 2
Hypertension
Obesity
Tobacco Use Cessation
Lead sponsor: Black Hills Center for American Indian Health
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Colorado, Denver
name: NuMedics, Inc.
name: Cheyenne River Sioux Tribe Telephone Authority
name: Missouri Breaks Industries Research, Inc.
name: Cheyenne River Sioux Tribe
First posted: 2008-02-06
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Glycosylated hemoglobin (HbgA1c)
timeFrame: Measured at Year 3
Secondary outcomes:
measure: Mean blood pressure
timeFrame: Measured at Year 3
measure: Low-density lipoprotein cholesterol (LDL)
timeFrame: Measured at Year 3
measure: BMI
timeFrame: Measured at Year 3
measure: Smoking status
timeFrame: Measured at Year 3
measure: Overall cost-effectiveness
timeFrame: Measured at Year 3
Other outcomes:
Locations:
city: Rapid City
country: United States
facility: Black Hills Center for American Indian Health
state: South Dakota
Study officials:
affiliation: Black Hills Center for American Indian Health
name: Jeffrey A. Henderson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.