Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial

详细信息    查看全文

• 作者：Leonard E Egede (1) (2) (3)
  Joni L Strom (2) (3)
  Jyotika Fernandes (4)
  Rebecca G Knapp (1) (5)
  Adebola Rojugbokan (6)
  
• 刊名：Trials
• 出版年：2011
• 出版时间：December 2011
• 年：2011
• 卷：12
• 期：1
• 全文大小：1713KB
• 参考文献：1. Centers for Disease Control and Prevention: / Press Release: older, more diverse population and longer lifespans contribute to increase. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2010.
  2. Centers for Disease Control and Prevention: / National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2007. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2008.
  3. SC DHEC, South Carolina Diabetes Prevention and Control Program and Diabetes Initiative of South Carolina, Medical University of South Carolina, Diabetes Center: / Burden of diabetes in South Carolina, 2009 Edition [Report]. Columbia, SC: Department of Health and Environmental Control; 2009.
  4. National Institute of Diabetes and Digestive and Kidney Diseases: / National Diabetes Statistics fact sheet: general information and national estimates on diabetes in the United States, 2005. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health; 2008.
  5. Montani S, Bellazzi R, Quaglini S, D'Annunzio Z: Meta analysis of the effect of the use of the computer based systems on the metabolic control of diabetes mellitus patients. / Diabetes Technology Ther 2001, 3:347-56. CrossRef
  6. Farmer A, Gibson O, Hayton P, Bryden K, Dudley C, Neil A, Tarassenko L: A real-time, mobile phone-based telemedicine system to support young adults with type 1 diabetes. / Inform Prim Care 2005,13(3):171-.
  7. Costa BM, Fitzgerald KJ, Jones KM, Dunning Am T: Effectiveness of IT-based diabetes management interventions: a review of the literature. / BMC Fam Pract 2009, 10:72. Review CrossRef
  8. Bellazzi R, Arcelloni M, Bensa G, Blankenfeld H, Brugués E, Carson E, Cobelli C, Cramp D, D'Annunzio G, De Cata P, De Leiva A, Deutsch T, Fratino P, Gazzaruso C, Garcìa A, Gergely T, Gómez E, Harvey F, Ferrari P, Hernando E, Boulos MK, Larizza C, Ludekke H, Maran A, Nucci G, Pennati C, Ramat S, Roudsari A, Rigla M, Stefanelli M: Design, methods, and evaluation directions of a multi-access service for the management of diabetes mellitus patients. / Diabetes Technol Ther 2003,5(4):621-. CrossRef
  9. Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A: WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes. / Diabetes Technol Ther 2008,10(3):160-. CrossRef
  10. Cherry JC, Moffatt TP, Rodriguez C, Dryden K: Diabetes disease management program for an indigent population empowered by telemedicine technology. / Diabetes Technol Ther 2002,4(6):783-1. CrossRef
  11. Farmer A, Gibson OJ, Tarassenko L, Neil A: A systematic review of telemedicine Interventions to support blood glucose self-monitoring in diabetes. / Diabet Med 2005,22(10):1372-. PMID: 16176199 CrossRef
  12. McMahon GT, Gomes HE, Hickson Hohne S, Hu TM, Levine BA, Conlin PR: Web-based care management in patients with poorly controlled diabetes. / Diabetes Care 2005,28(7):1624-. CrossRef
  13. Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, Franko CM, Anglin RA, Obrosky DS, Derubertis FR: Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. / Diabetes Care 2010,33(3):478-4. Epub 2009 Dec 15 CrossRef
  14. Garg SK, Bookout TR, McFann KK, Kelly WC, Beatson C, Ellis SL, Gutin RS, Gottlieb PA: Improved glycemic control in intensively treated adult subjects with type 1 diabetes using insulin guidance software. / Diabetes Technol Ther 2008,10(5):369-5. CrossRef
  15. Earle KA, Istepanian RS, Zitouni K, Sungoor A, Tang B: Mobile telemonitoring for achieving tighter targets of blood pressure control in patients with complicated diabetes: a pilot study. / Diabetes Technol Ther 2010,12(7):575-. CrossRef
  16. Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP: A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. / J Am Med Inform Assoc 2009,16(4):446-6. Epub Apr 23. PMID: 19390093 CrossRef
  17. Sutherland D, Hayter M: Structured review: evaluating the effectiveness of nurse case managersin improving health outcomes in three major chronic diseases. / J Clin Nurs 2009,18(21):2978-2. Epub 2009 Sep 11. Review. PMID: 19747197 CrossRef
  18. Aubert RE, Herman WH, Waters J, Moore W, Sutton D, Peterson BL, Bailey CM, Koplan JP: Nurse case management to improve glycemic control in diabetic patients in a health maintenance organization. A randomized, controlled trial. / Ann Intern Med 1998,129(8):605-2. PMID: 9786807
  19. Piette JD, Weinberger M, Kraemer FB, McPhee SJ: Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System: a randomized controlled trial. / Diabetes Care 2001,24(2):202-. PMID: 11213866 CrossRef
  20. Stuckey HL, Dellasega C, Graber NJ, Mauger DT, Lendel I, Gabbay RA: Diabetes nurse case management and motivational interviewing for change (DYNAMIC): study design and baseline characteristics in the Chronic Care Model for type 2 diabetes. / Contemp Clin Trials 2009,30(4):366-4. Epub 2009 Mar CrossRef
  21. Welch G, Garb J, Zagarins S, Lendel I, Gabbay RA: Nurse diabetes case management interventions and blood glucose control: results of a meta-analysis. / Diabetes Res Clin Pract 2010,88(1):1-. Epub 2010 Feb 8. PMID: 20116879 CrossRef
  22. Curtis J, Lipke S, Effland S, Dickinson B, McCabe A, Russell B, Russell M, Bloomquist P, Wilson C: Effectiveness and safety of medication adjustments by nurse case managers to control hyperglycemia. / Diabetes Educ 2009,35(5):851-. Epub 2009 Aug 27. PMID: 19713556. CrossRef
  23. Gabbay RA, Lendel I, Saleem TM, Shaeffer G, Adelman AM, Mauger DT, Collins M, Polomano RC: Nurse case management improves blood pressure, emotional distress and diabetes complication screening. / Diabetes Res Clin Pract 2006,71(1):28-5. Epub 2005 Jul 12. PMID: 16019102 CrossRef
  24. Gary TL, Batts-Turner M, Yeh HC, Hill-Briggs F, Bone LR, Wang NY, Levine DM, Powe NR, Saudek CD, Hill MN, McGuire M, Brancati FL: The effects of a nurse case manager and a community health worker team on diabetic control, emergency department visits, and hospitalizations among urban African Americans with type 2 diabetes mellitus: a randomized controlled trial. / Arch Intern Med 2009,169(19):1788-4. PubMed PMID: 19858437 CrossRef
  25. / FORA 2-in-1 BP + BG meter: FORA D15g TeleHealth System and Gateway: FORA GW9014A. FORA Care, Inc Newbury Park, California; 2008.
  26. Altman DG, Schulz KF, Moher D, / et al.: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. / Ann Intern Med 2001,134(8):663-94.
  27. Hedeker D, Gibbons RD: / Longitudinal Data Analysis. New York: Wiley; 2006.
  28. Baron RM, Kenny DA: The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. / J Pers Soc Psychol 1986,51(6):1173-182. CrossRef
  29. Holmbeck GN: Toward terminological, conceptual, and statistical clarity in the study of mediators and moderators: examples from the child-clinical and pediatric psychology literatures. / Journal of Consulting and Clinical Psychology 1997,65(4):599-10. CrossRef
  30. MacKinnon DP, Fairchild AJ, Fritz MS: Mediation analysis. / Annu Rev Psychol 2007, 58:593. CrossRef
  31. Ware JE, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity. / Medical Care 1996, 34:220-33. CrossRef
  32. Garcia AA, Villagomez ET, Brown SA, Kouzekanani K, Hanis CL: The Starr County Diabetes Education Study: development of the Spanish-language diabetes knowledge questionnaire. / Diabetes Care 2001,24(1):16-1. CrossRef
  33. Egede LE, Ellis C: Development and psychometric properties of the 12-item diabetes fatalism scale. / J Gen Intern Med 2010,25(1):61-. Epub 2009 Nov 12. PMID: 19908102 CrossRef
  34. Wallston KA, Rothman RL, Cherrington A: Psychometric properties of the Perceived Diabetes Self-Management Scale (PDSMS). / J Behav Med 30(5):395-01. Epub 2007 May 24. PMID: 17522972
  35. Toobert DJ, Hampson SE, Glasgow RE: The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. / Diabetes Care 2000,23(7):943-50. CrossRef
  36. Krousel-Wood M, Islam T, Webber LS, Re RN, Morisky DE, Muntner P: New Medication Adherence Scale Versus Primary Fill Rates in Seniors with Hypertension. / Am J Manag Care 2009,12(1):59-6.
  37. National Center for Health Statistics (2004): / Survey Questionnaire, National Health Interview Survey. National Center for Health Statistics, Hyattsville, Maryland; 2002.
  38. Sherbourne CD, Stewart AL: The MOS Social Support Survey. / Social Science and Medicine 1991, 32:705-4. CrossRef
  39. Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J: Development of a brief test to measure functional health literacy. / Patient Educ Couns 1999,38(1):33-2. CrossRef
  40. Kroenke K, Spitzer RL, Williams JB: The PHQ-9: validity of a brief depression severity measure. / J Gen Intern Med 2001, 6:606-13. CrossRef
  41. Charlson ME, Pompei P, Ales KL, MacKenzie CR: A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. / J Chronic Dis 1987, 40:373-83. CrossRef
  42. Borkovec TC, Nau SD: Credibility of analogue therapy rationales. / J Behav Ther Exp Psychiat 1972, 3:257-0. CrossRef
  
• 作者单位：Leonard E Egede (1) (2) (3)
  Joni L Strom (2) (3)
  Jyotika Fernandes (4)
  Rebecca G Knapp (1) (5)
  Adebola Rojugbokan (6)
  
  1. Center for Disease Prevention and Health Interventions for Diverse Populations, Ralph H. Johnson Veterans Affairs Medical Center, 109 Bee Street, Charleston, South Carolina, 29401, USA
  2. Department of Medicine, Division of General Internal Medicine & Geriatrics, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, South Carolina, 29425, USA
  3. Center for Health Disparities Research, Medical University of South Carolina, Charleston, 135 Rutledge Avenue, Charleston, South Carolina, 29425, USA
  4. Department of Medicine, Division of Endocrinology, Diabetes, and Medical Genetics, Medical University of South Carolina, 96 Jonathan Lucas Street, Charleston, South Carolina, 29425, USA
  5. Department of Medicine, Division of Biostatistics and Epidemiology, Medical University of South Carolina, 135 Cannon Street, Charleston, South Carolina, 29425, USA
  6. Franklin C. Fetter Family Health Center, Inc., 51 Nassau Street, Charleston, South Carolina, 29403, USA
  

文摘

Background An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for < 10% of the variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Use of telemonitoring systems offer new opportunities to support patients with T2DM while waiting to be seen by their health care providers at actual office visits. A variety of interventions testing the efficacy of telemedicine interventions have been conducted, but the outcomes have yielded equivocal results, emphasizing the shortage of controlled, randomized trials in this area. This study provides a unique opportunity to address this gap in the literature by optimizing two strategies that have been shown to improve glycemic control, while simultaneously implementing clinical outcomes measures, using a sufficient sample size, and offering health care delivery to rural, underserved and low income communities with T2DM who are seen at Federally Qualified Health Centers (FQHCs) in coastal South Carolina. Methods We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200) male and female participants, 18 years of age or older and with an HbA1c ?8%, will be randomized into one of two groups: (1) an intervention arm employing the innovative FORA system coupled with nurse case management or (2) a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care. Discussion Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM) for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's. Trial Registration National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489