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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608387
• Other study ID #: 453
• Secondary ID: 1U01HL087422
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: June 3, 2014
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2014
• Source: Black Hills Center for American Indian Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Hypertension
• Obesity
• Tobacco Use Cessation

Intervention

Behavioral:
• Chronic disease management Web-based software
Participants will have access to remotely based medical providers through the use of the Web-based software.

Locations

Country	Name	City	State
United States	Black Hills Center for American Indian Health	Rapid City	South Dakota

Sponsors (7)

Lead Sponsor	Collaborator
Black Hills Center for American Indian Health	Cheyenne River Sioux Tribe, Cheyenne River Sioux Tribe Telephone Authority, Missouri Breaks Industries Research, Inc., NuMedics, Inc., University of Colorado, Denver, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin (HbgA1c)		Measured at Year 3	No
Secondary	Mean blood pressure		Measured at Year 3	No
Secondary	Low-density lipoprotein cholesterol (LDL)		Measured at Year 3	No
Secondary	BMI		Measured at Year 3	No
Secondary	Smoking status		Measured at Year 3	No
Secondary	Overall cost-effectiveness		Measured at Year 3	No