The Journal of Primary Prevention

, Volume 33, Issue 4, pp 209–222 | Cite as

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

  • Jeffrey A. Henderson
  • Jessica Chubak
  • Joan O’Connell
  • Maria C. Ramos
  • Julie Jensen
  • Jared B. Jobe
  • On Behalf of the LOWPK Project Team
Research Methods and Practice

Abstract

We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation–dwelling adult American Indian men and women with type 2 diabetes who are at high risk for CVD. Enrollment on a rolling basis of 180 planned participants began during 2009; an average 18-month follow-up was completed by June 2011. The primary outcome variable is change in glycosylated hemoglobin level after an average 18-month follow-up period. Secondary outcome variables include changes in low-density lipoprotein cholesterol, systolic blood pressure, body mass index, and smoking status, as well as an evaluation of intervention cost-effectiveness. If effective, the LOWPK trial may serve as a guide for future chronic disease intervention trials in remote, technologically challenged settings.

Keywords

American Indians Cardiovascular disease Risk reduction Intervention Web-based 

Notes

Acknowledgments

The Lakota Oyate Wicozani Pi Kte study was funded by the National Heart, Lung, and Blood Institute (UO1 HL087422). The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official view of the National Heart, Lung, and Blood Institute. We acknowledge the contributions and support of the Indian Health Service, the Cheyenne River Sioux Tribe; staff of the University of Washington, including Corinne Hunt, Phu T. Van, Andrew Bogart, Carolyn Noonan, and Odile Lallemand; Dorene Levie and Khazi Ahmed of NuMedics, Inc.; staff associated with the Black Hills Center for American Indian Health, including Monique Giago, Stephanie Big Crow and Crissy Whitewolf; and staff of Missouri Breaks Industries Research, Inc., including Marcia O’Leary, Kendra Enright, Anne Chasing Hawk, Marie Gross, Jay Kunf, and Lillian Brown. We also acknowledge Lifescan, Inc., who provided replacement One Touch Ultra glucometer devices and USB cables (to connect the glucometers to participant computers) to the study at no cost.

References

  1. Borushek, A. (2005). The Calorie King ® calorie, fat & carbohydrate counter. Costa Mesa, CA: Family Health Publications.Google Scholar
  2. Brazier, J. E., & Roberts, J. (2004). The estimation of a preference-based measure of health from the SF-12. Medical Care, 42, 851–859.PubMedCrossRefGoogle Scholar
  3. CDC Diabetes Cost-Effectiveness Group. (2002). Cost-effectiveness of intensive glycemic control, intensified hypertension control, and serum cholesterol level reduction for type 2 diabetes. Journal of the American Medical Association, 287, 2542–2551.CrossRefGoogle Scholar
  4. Centers for Disease Control and Prevention. (1998). Tobacco use among U.S. racial/ethnic minority groups, African Americans, American Indians and Alaska Natives, Asian Americans and Pacific Islanders, Hispanics: A report of the Surgeon General (Executive summary). Morbidity and Mortality Weekly Report, 47(No. RR-18), v–xv, 1–16.Google Scholar
  5. Centers for Disease Control and Prevention. (2001). Cigarette smoking among adults—United States, 1999. Morbidity and Mortality Weekly Report, 50, 869–873.Google Scholar
  6. Centers for Disease Control and Prevention. (2004). Disparities in premature deaths from heart disease—50 States and the District of Columbia, 2001. Morbidity and Mortality Weekly Report, 53, 121–125.Google Scholar
  7. Clark, N. M., & Dodge, J. A. (1999). Exploring self-efficacy as a predictor of disease management. Health Education & Behavior, 26, 72–89.CrossRefGoogle Scholar
  8. Clark, N. M., & Zimmerman, B. J. (1990). A social cognitive view of self-regulated learning about health. Health Education Research, 5, 371–379.CrossRefGoogle Scholar
  9. Committee on Quality of Health Care in America, Institute of Medicine. (2001). Crossing the quality chasm: A new health system for the 21 st century. Washington, DC: The National Academies Press.Google Scholar
  10. Davis, C. E., Hunsberger, S., Murray, D. M., Fabsitz, R. R., Himes, J. H., Stephenson, L. K., et al. (1999). Design and statistical analysis for the Pathways Study. American Journal of Clinical Nutrition, 69(4 Suppl), 760S–763S.PubMedGoogle Scholar
  11. Gaede, P., Vedel, P., Larsen, N., Jensen, G. V., Parving, H. H., & Pedersen, O. (2003). Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. New England Journal of Medicine, 348, 383–393.PubMedCrossRefGoogle Scholar
  12. Galloway, J. M. (2005). Cardiovascular health among American Indians and Alaska Natives: Successes, challenges, and potentials. American Journal of Preventive Medicine, 29(5 Suppl 1), 11–17.PubMedCrossRefGoogle Scholar
  13. Gold, M. R., Siegel, J. E., Russell, L. B., & Weinstein, M. C. (Eds.). (1996). Cost-effectiveness in health and medicine. New York, NY: Oxford University Press.Google Scholar
  14. Goldberg, H. I., Lessler, D. S., Mertens, K., Eytan, T. A., & Cheadle, A. D. (2004). Self-management support in a web-based medical record: A pilot randomized controlled trial. Joint Commission Journal on Quality and Patient Safety, 30, 629–635. 589.Google Scholar
  15. Goldberg, H. I., Ralston, J. D., Hirsch, I. B., Hoath, J. I., & Ahmed, K. I. (2003). Using an internet comanagement module to improve the quality of chronic disease care. Joint Commission Journal on Quality and Patient Safety, 29, 443–451.Google Scholar
  16. Haddix, A. C., Teutsch, S. M., & Corso, P. S. (Eds.). (2002). Prevention effectiveness: A guide to decision analysis and economic evaluation. New York, NY: Oxford University Press.Google Scholar
  17. Howard, B. V., Lee, E. T., Cowan, L. D., Devereux, D. B., Galloway, J. M., Go, O. T., et al. (1999). Rising tide of cardiovascular disease in American Indians: The Strong Heart Study. Circulation, 99, 2389–2395.PubMedCrossRefGoogle Scholar
  18. Indian Appropriations Act of March 2, 1889, 25 U. S. C. § 888 (1889).Google Scholar
  19. Indian Health Service. (2000). Trends in Indian health 1998–1999. Rockville, MD: Office of Public Health, U.S. Department of Human Health and Services.Google Scholar
  20. Lee, E. T., Howard, B. V., Go, O., Savage, P. J., Fabsitz, R. R., Robbins, D. C., et al. (2000). Prevalence of undiagnosed diabetes in three American Indian populations. A comparison of the 1997 American Diabetes Association diagnostic criteria and the 1985 World Health Organization diagnostic criteria: The Strong Heart Study. Diabetes Care, 23, 181–186.PubMedCrossRefGoogle Scholar
  21. Lee, E. T., Howard, B. V., Savage, P. J., Cowan, L. D., Fabsitz, R. R., Oopik, A. J., et al. (1995). Diabetes and impaired glucose tolerance in three American Indian populations aged 45–74 years: The Strong Heart Study. Diabetes Care, 18, 599–610.PubMedCrossRefGoogle Scholar
  22. Lee, E. T., Welty, T. K., Cowan, L. D., Wang, W., Rhoades, D. A., Devereux, R., et al. (2002). Incidence of diabetes in American Indians of three geographic areas: The Strong Heart Study. Diabetes Care, 25, 49–54.PubMedCrossRefGoogle Scholar
  23. Lee, E. T., Welty, T. K., Fabsitz, R., Cowan, L. D., Le, N. A., Oopik, A. J., et al. (1990). The Strong Heart Study: A study of cardiovascular disease in American Indians: Design and methods. American Journal of Epidemiology, 132, 1141–1155.PubMedGoogle Scholar
  24. National Center for Health Statistics. (1994). Plan and operation of the third national health and nutrition examination survey, 1988–1994. Hyattsville, MD: US Department of Health and Human Services. DHHS Publication No. 94–1308.Google Scholar
  25. Nez Henderson, P., Jacobsen, C., Beals, J., & AI-SUPERPFP Team. (2005). Correlates of cigarette smoking among selected Southwest and Northern plains tribal groups: The AI-SUPERPFP Study. American Journal of Public Health, 95, 867–872.PubMedCrossRefGoogle Scholar
  26. O’Connell, J. M., Brunson, D., Anselmo, T., & Sullivan, P. W. (2005). Costs and savings associated with community water fluoridation programs in Colorado. Preventing Chronic Disease, 2(Special Issue), A06.PubMedGoogle Scholar
  27. Palmer, A. J., Roze, S., Valentine, W. J., Spinas, G. A., Shaw, J. E., & Zimmet, P. Z. (2004). Intensive lifestyle changes or metformin in patients with impaired glucose tolerance: Modeling the long-term health economic implications of the Diabetes Prevention Program in Australia, France, Germany, Switzerland, and the United Kingdom. Clinical Therapeutics, 26, 304–321.PubMedCrossRefGoogle Scholar
  28. Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385–401.CrossRefGoogle Scholar
  29. Rothman, R. L., Malone, R., Bryant, B., Shintani, A. K., Crigler, B., Dewalt, D. A., et al. (2005). A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes. American Journal of Medicine, 118, 276–284.PubMedCrossRefGoogle Scholar
  30. Selvin, E., Marinopoulos, S., Berkenblit, G., Rami, T., Brancati, F. L., Powe, N. R., et al. (2004). Meta-analysis: Glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Annals of Internal Medicine, 141, 421–431.PubMedGoogle Scholar
  31. Slattery, M. L., Schumacher, M. C., Lanier, A. P., Edwards, S., Edwards, R., Murtaugh, M. A., et al. (2007). A prospective cohort of American Indian and Alaska Native people: Study design, methods, and implementation. American Journal of Epidemiology, 166, 606–615.PubMedCrossRefGoogle Scholar
  32. Sullivan, S. D., Buist, A. S., & Weiss, K. (2003). Health outcomes assessment and economic evaluation in COPD: Challenges and opportunities. The European Respiratory Journal Supplement, 41, 1s–3s.PubMedCrossRefGoogle Scholar
  33. Teufel-Shone, N. I., Fitzgerald, C., Teufel-Shone, L., & Gamber, M. (2009). Systematic review of physical activity interventions implemented with American Indian and Alaska Native populations in the United States and Canada. American Journal of Health Promotion, 23, S8–S32.PubMedCrossRefGoogle Scholar
  34. Tworoger, S. S., Yasui, Y., Chang, L., Stanczyk, F. Z., & McTiernan, A. (2004). Specimen allocation in longitudinal biomarker studies: Controlling subject-specific effects by design. Cancer Epidemiology, Biomarkers and Prevention, 13, 1257–1260.PubMedCrossRefGoogle Scholar
  35. Wagner, E. H., Sandhu, N., Newton, K. M., McCulloch, D. K., Ramsey, S. D., & Grothaus, L. C. (2001). Effect of improved glycemic control on health care costs and utilization. Journal of the American Medical Association, 285, 182–189.PubMedCrossRefGoogle Scholar
  36. Ware, J., Jr., Kosinski, M., & Keller, S. D. (1996). A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 34, 220–233.PubMedCrossRefGoogle Scholar
  37. Welty, T. K., Lee, E. T., Yeh, J., Cowan, L. D., Go, O., Fabsitz, R. R., et al. (1995). Cardiovascular disease risk factors among American Indians: The Strong Heart Study. American Journal of Epidemiology, 142, 269–287.PubMedGoogle Scholar
  38. Welty, T. K., Rhoades, D. A., Yeh, F., Lee, E. T., Cowan, L. D., Fabsitz, R. R., et al. (2002). Changes in cardiovascular disease risk factors among American Indians: The Strong Heart Study. Annals of Epidemiology, 12, 97–106.PubMedCrossRefGoogle Scholar
  39. Zhang, P., Engelgau, M. M., Norris, S. L., Gregg, E. W., & Narayan, K. M. (2004). Application of economic analysis to diabetes and diabetes care. Annals of Internal Medicine, 140, 972–977.PubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Jeffrey A. Henderson
    • 1
  • Jessica Chubak
    • 4
  • Joan O’Connell
    • 5
  • Maria C. Ramos
    • 1
  • Julie Jensen
    • 1
  • Jared B. Jobe
    • 2
    • 3
  • On Behalf of the LOWPK Project Team
  1. 1.Black Hills Center for American Indian HealthRapid CityUSA
  2. 2.Division of Cardiovascular SciencesNational Heart, Lung, and Blood InstituteBethesdaUSA
  3. 3.Division of Cancer Control and Population SciencesNational Cancer InstituteRockvilleUSA
  4. 4.Group Health Research InstituteSeattleUSA
  5. 5.Department of Community and Behavioral HealthColorado School of Public Health, University of Colorado DenverAuroraUSA

Personalised recommendations