-  2019 
<br/><br/> BACKGROUND: Diabetes mellitus (DM) is a complex chronic disease with less than 63% of patients achieving a target HbA1c <7% and only 7% meeting combined glycemic, lipid, and blood pressure (BP) goals. Both community health workers (CHWs) and mobile health (mHealth) have the potential to improve patient-health care team communication and improve patient self-management.  METHODS: A total of 166 Medicaid patients with type 2 DM, HbA1c >8.0%, with 3 or more out of 13 unmet wellness and clinical goals were randomized into 3 groups: Group 1 (n = 56) was assisted by the Voxiva Care4Life diabetes mHealth system (C4L) alone; group 2 (n = 56) was assisted by a CHW only; and group 3 (n = 54) had both C4L and a CHW. We recruited participants from the outpatient clinics of 3 Washington, DC, medical centers. We followed these participants for 12 months, comparing achievement of wellness behaviors and clinical outcome goals across the 3 health care strategies.  OBJECTIVES: We evaluated innovative strategies to improve care of DM for Medicaid patients using a cell phone (mHealth) and a CHW. We hypothesized that (1) mHealth plus a CHW is superior to the benefits of mHealth alone or a CHW alone; and (2) mHealth alone will improve self-management and DM outcomes compared with baseline. Our primary end point was increased achievement of wellness behaviors and clinical goals. Secondary end points included (1) HbA1c; (2) medical use (emergency department [ED] visits, hospitalizations, urgent office visits); (3) Low-density lipoprotein (LDL) cholesterol; (4) BP; (5) medication adherence; (6) diet, exercise, blood glucose monitoring, and BP testing; and (7) diabetes distress.  RESULTS: We saw the primary end point, increased number of met wellness and clinical goals, in all 3 groups (mean, 1.4 additional goals; P = .001). On average, groups improved goals met by 20% from baseline. Only 11 (6.6%) participants dropped out. At 12 months, HbA1c dropped 1.2% (P < .0001; nonsignificant difference across groups). Of the total participants, 51% achieved an HbA1c <9% and 30% achieved an HbA1c <8%. We observed improvements in medication adherence (P = .02), hospitalizations (P = .03), urgent care visits (P = .03), and diabetes distress (P < .0001), with no significant difference across groups. C4L use was sustained over 12-month follow-up, with participants receiving a mean 3.75 messages from C4L/day. Participants sent a median 3.9 messages into C4L /week. We saw a trend for higher participant-to-C4L messaging in the C4L + CHW group. Patient engagement with C4L weekly nonglucose measures (exercise, weight, medication adherence) was modest, with median response approximately 10 out of 52 weeks for all 3 groups. Participants were uniformly enthusiastic about participating in the program.  SUMMARY: The C4L + CHW strategy was not superior to C4L or CHW alone. All 3 approaches resulted in significant improvement of wellness and clinical goals, HbA1c, urgent health care use, and diabetes distress in an urban Medicaid population. The results of this study provide insight into the future use of CHWs and mHealth for the improvement of diabetes care. Copyright © 2019. George Washington University. All Rights Reserved. 
<br/><br/><br/>English 
<br/><br/><label>Subjects--Topical Terms: </label><br/>IN PROCESS -- NOT YET INDEXED
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Diabetes Institute<br/>MedStar Health Research Institute<br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Function: </label><br/>Review