Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

Samuel N Forjuoh, Jane N Bolin, John C Huber Jr, Ann M Vuong, Omolola E Adepoju, Janet W Helduser, Dawn S Begaye, Anne Robertson, Darcy M Moudouni, Timethia J Bonner, Kenneth R McLeroy, Marcia G Ory, Samuel N Forjuoh, Jane N Bolin, John C Huber Jr, Ann M Vuong, Omolola E Adepoju, Janet W Helduser, Dawn S Begaye, Anne Robertson, Darcy M Moudouni, Timethia J Bonner, Kenneth R McLeroy, Marcia G Ory

Abstract

Background: Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons.

Methods: We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model.

Results: Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants' diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups.

Conclusions: Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control.

Trial registration: Clinicaltrials.gov Identifier: NCT01221090.

Figures

Figure 1
Figure 1
Consort table.
Figure 2
Figure 2
Lowess curves.

References

    1. Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001;24:561–587. doi: 10.2337/diacare.24.3.561.
    1. Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25:1159–1171. doi: 10.2337/diacare.25.7.1159.
    1. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002;288:2469–2475. doi: 10.1001/jama.288.19.2469.
    1. American Diabetes Association. Standards of medical care in diabetes—2011. Diabetes Care. 2011;34:S11–S61.
    1. Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National standards for diabetes self-management education. Diabetes Care. 2010;34(Suppl 1):S89–S96.
    1. Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, Dagogo-Jack S, Davidson JA, Einhorn D, Ganda O, Garber AJ, Hirsch IB, Horton ES, Ismail-Beigi F, Jellinger PS, Jones KL, Jovanovic L, Lebovitz H, Levy P, Moghissi ES, Orzeck EA, Vinik AI, Wyne KL. AACE Task Force for Developing Diabetes Comprehensive Care Plan: American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011;17(Suppl 2):1–53.
    1. Deakin T, McShane CE, Cade JE, Williams RD. Review: group based education in self management strategies improves outcomes in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005;2 CD003417.
    1. Franciosi M, Lucisano G, Pellegrini F, Cantarello A, Consoli A, Cucco L, Ghidelli R, Sartore G, Sciangula L, Nicolucci A. ROSES Study Group: ROSES: role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial. Diabet Med. 2011;28:789–796. doi: 10.1111/j.1464-5491.2011.03268.x.
    1. Malanda UL, Welschen LM, Riphagen II, Dekker JM, Nijpels G, Bot SD. Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. Cochrane Database Syst Rev. 2012;18 CD005060.
    1. Farmer AJ, Wade AN, French DP, Simon J, Yudkin P, Gray A, Craven A, Goyder L, Holman RR, Mant D, Kinmonth AL, Neil HA. DiGEM Trial Group: Blood glucose self-monitoring in type 2 diabetes: a randomised controlled trial. Health Technol Assess. 2009;13(15):1–50.
    1. Kleefstra N, Bilo HJ. The additional value of self-monitoring of blood glucose in patients with type 2 diabetes not using insulin is 'not proven'. Evid Based Med. 2011;16:42–43. doi: 10.1136/ebm1150.
    1. Clar C, Barnard K, Cummins E, Royle P, Waugh N. Aberdeen Health Technology Assessment Group: Self-monitoring of blood glucose in type 2 diabetes: systematic review. Health Technol Assess. 2010;14:1–140.
    1. Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999;37:5–14. doi: 10.1097/00005650-199901000-00003.
    1. Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001;39:1217–1223. doi: 10.1097/00005650-200111000-00008.
    1. Foster G, Taylor SJ, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education programmes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev. 2007;17 CD005108.
    1. Centers for Disease Control and Prevention. Sorting through the evidence for the Arthritis Self-Management Program and the Chronic Disease Self-Management Program: Executive summary of ASMP/CDSMP meta-analysis. 3. (accessed January 27, 2013)
    1. Yeo PP, Thai AC, Wang KW, Chan L, Lui KF, Kueh YK, Lun KC, Cheah JS, Tan BY, Lim P. Home blood glucose monitoring, glycaemic control and diabetic complications. Ann Acad Med Singapore. 1985;14:247–251.
    1. Lam KS, Ma JT, Chan EY, Yeung RT. Sustained improvement in diabetic control on long-term self-monitoring of blood glucose. Diabet Res Clin Pract. 1986;2:165–171. doi: 10.1016/S0168-8227(86)80018-3.
    1. Hansen B. Handheld computers in diabetes management. Diabetes Self Manag. 2002;19:43–44. 46, 48–49.
    1. Tsang MW, Mok M, Kam G, Jung M, Tang A, Chan U, Chu CM, Li I, Chan J. Improvement in diabetes control with a monitoring system based on a hand-held, touch-screen electronic diary. J Telemed Telcare. 2001;7:47–50.
    1. Ma Y, Olendzki BC, Chiriboga D, Rosal M, Sinagra E, Crawford S, Hafner AR, Pagoto SL, Magner RP, Ockene IS. PDA-assisted low glycemic index dietary intervention for type II diabetes: a pilot study. Eur J Clin Nutr. 2006;60:1235–1243. doi: 10.1038/sj.ejcn.1602443.
    1. Kaufman N. Internet and information technology use in treatment of diabetes. Int J Clin Pract Suppl. 2010;166:41–46.
    1. Hersh WR, Wallace JA, Patterson PK, Shapiro SE, Kraemer DF, Eilers GM, Chan BK, Greenlick MR, Helfand M. Telemedicine for the Medicare population: pediatric, obstetric, and clinician-indirect home interventions. Evid Rep Technol Assess. 2001;24:1–32.
    1. Forjuoh SN, Reis MD, Couchman GR, Ory MG, Mason S, Molonket-Lanning S. Incorporating PDA use in diabetes self-care: A Central Texas Primary Care Research Network (CenTexNet) study. J Am Board Fam Med. 2007;20:375–384. doi: 10.3122/jabfm.2007.04.060166.
    1. Forjuoh SN, Reis MD, Couchman GR, Ory MG. Improving diabetes self-care with a PDA in ambulatory care. Telemed E Health. 2008;14:273–279. doi: 10.1089/tmj.2007.0053.
    1. National Institute of Diabetes and Digestive and Kidney Diseases. National diabetes statistics, 2007 fact sheet. (accessed January 27, 2013)
    1. Egede LE, Mueller M, Echols CL, Gebregziabher M. Longitudinal differences in glycemic control by race/ethnicity among veterans with type 2 diabetes. Med Care. 2010;48:527–533. doi: 10.1097/MLR.0b013e3181d558dc.
    1. Wilkes AE, Bordenave K, Vinci L, Peek ME. Addressing diabetes racial and ethnic disparities: lessons learned from quality improvement collaboratives. Diabetes Manag (Lond) 2011;1:653–660. doi: 10.2217/dmt.11.48.
    1. Holland AT, Zhao B, Wong EC, Choi SE, Wong ND, Palaniappan LP. Racial/ethnic differences in control of cardiovascular risk factors among type 2 diabetes patients in an insured, ambulatory care population. J Diabetes Complications. 2013;27:34–40. doi: 10.1016/j.jdiacomp.2012.08.006.
    1. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2011.
    1. Sadowski D, Devlin M, Hussain A. Diabetes self-management activities for Latinos living in non-metropolitan rural communities: a snapshot of an underserved rural state. J Immigr Minor Health. 2012;14:990–998. doi: 10.1007/s10903-012-9602-x.
    1. Liebman J, Heffernan D, Sarvela P. Establishing diabetes self-management in a community health center serving low-income Latinos. Diabetes Educ. 2007;33(Suppl 6):132S–138S.
    1. Gamm L, Hutchison L, Bellamy G, Dabney BJ. Rural healthy people 2010: identifying rural health priorities and models for practice. J Rural Health. 2002;18:9–14. doi: 10.1111/j.1748-0361.2002.tb00869.x.
    1. U.S. Department of Health and Human Services. Office of Disease Prevention and Health Promotion: Healthy People 2020. . (accessed October 17, 2012)
    1. Agency for Healthcare Research and Quality. 2011 National Healthcare Disparities Report. 2011 National Healthcare Disparities Report: 2011 National Healthcare Disparities Report; 2011 National Healthcare Disparities Report. . (accessed January 25, 2012.
    1. Smith A. Smart phone adoption and usage. Pew Internet & American Life Project. . (accessed October 22, 2012)
    1. Anton SD, LeBlanc E, Allen HR, Karabetian CK, Sacks F, Bray G, Williamson DA. Use of a computer tracking system to monitor and provide feedback on dietary goals for calorie restricted diets: the POUNDS LOST study. J Diabetes Sci Technol. 2012;6:1216–1225. doi: 10.1177/193229681200600527.
    1. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T. CONSORT GROUP: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663–694. doi: 10.7326/0003-4819-134-8-200104170-00012.
    1. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis. New York: Wiley-Interscience; 2004.
    1. McGowan P. The efficacy of diabetes patient education and self-management education in type 2 diabetes. Can J Diabetes. 2011;35:46–53. doi: 10.1016/S1499-2671(11)51008-1.
    1. Ory MG, Smith ML, Mier N, Wernicke M. The science of sustaining health behavior change: the health maintenance consortium. Am J of Health Behav. 2010;34:647–659.
    1. Guerci B, Drouin P, Grange V, Bougneres P, Fontaine P, Kerlan V, Passa P, Thivolet C, Vialettes B, Charbonnel B. ASIA Group: Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Diabetes Metab. 2003;29:587–594. doi: 10.1016/S1262-3636(07)70073-3.
    1. Sevick MA, Trauth JM, Ling BS, Anderson RT, Piatt GA, Kilbourne AM, Goodman RM. Patients with complex chronic diseases: perspectives on supporting self-management. J Gen Intern Med. 2007;22:434–444.
    1. Lorig K, Ritter PL, Villa F, Piette JD. Spanish diabetes self-management with and without automated telephone reinforcement: two randomized trials. Diabetes Care. 2008;31:408–414.
    1. Glasgow RE, Boles SM, McKay HG, Feil EG, Barrera M Jr. The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results. Prev Med. 2003;36:410–419. doi: 10.1016/S0091-7435(02)00056-7.
    1. Vuong AM, Huber JC Jr, Bolin JN, Ory MG, Moudouni DM, Helduser J, Begaye D, Bonner TJ, Forjuoh SN. Factors affecting acceptability and usability of technological approaches to diabetes self-management: a case study. Diabetes Technol Ther. 2012;14:1178–1182. doi: 10.1089/dia.2012.0139.
    1. Adams AS, Zhang F, Mah C, Grant RW, Kleinman K, Meigs JB, Ross-Degnan D. Race differences in long-term diabetes management in an HMO. Diabetes Care. 2005;28:2844–2849. doi: 10.2337/diacare.28.12.2844.
    1. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory MG, Ogedegbe G, Orwig D, Ernst D, Czajkowski S. Treatment Fidelity Workgroup of the NIH Behavior Change Consortium: Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the Behavior Change Consortium. Health Psychol. 2004;23(5):443–451.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe