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Background: Past mobile health (mHealth) efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, collection of biometric data, electronic coaching, email, and collection of lifestyle information., Objective: The primary objective was to enhance patient activation and self-management of T2D using the US Department of Defense's Mobile Health Care Environment (MHCE) in a patient-centered medical home setting., Methods: A multisite study, including a user-centered design and a controlled trial, was conducted within the US Military Health System. Phase I assessed preferences regarding the enhancement of the enabling technology. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the intervention (n=123, received mHealth technology and behavioral messages tailored to Patient Activation Measure [PAM] level at baseline) or the control group (n=117, received equipment but not messaging. The primary outcome measure was PAM scores. Secondary outcome measures included Summary of Diabetes Self-Care Activities (SDSCA) scores and cardiometabolic outcomes. We used generalized estimating equations to estimate changes in outcomes., Results: The final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA 1c ) of 7.5%, mean BMI of 32.7, and a mean duration of T2D diagnosis of 9.8 years. At month 12, the control group showed significantly greater improvements compared with the intervention group in PAM scores (control mean 7.49, intervention mean 1.77; P=.007), HbA 1c (control mean -0.53, intervention mean -0.11; P=.006), and low-density lipoprotein cholesterol (control mean -7.14, intervention mean 4.38; P=.01). Both groups showed significant improvement in SDSCA, BMI, waist size, and diastolic blood pressure; between-group differences were not statistically significant. Except for patients with the highest level of activation (PAM level 4), intervention group patients exhibited significant improvements in PAM scores. For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in HbA 1c (control mean -0.09, intervention mean -0.52; P=.04), BMI (control mean 0.58, intervention mean -1.22; P=.01), and high-density lipoprotein cholesterol levels (control mean -4.86, intervention mean 3.56; P<.001). Significant improvements were seen in AM scores, SDSCA, and waist size for both groups and in diastolic and systolic blood pressure for the control group; the between-group differences were not statistically significant. The percentage of participants who were engaged with MHCE for ≥50% of days period was 60.7% (68/112; months 0-3), 57.4% (62/108; months 3-6), 49.5% (51/103; months 6-9), and 43% (42/98; months 9-12)., Conclusions: Our study produced mixed results with improvement in PAM scores and outcomes in both the intervention and control groups. Structural design issues may have hampered the influence of tailored behavioral messaging within the intervention group., Trial Registration: ClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037., International Registered Report Identifier (irrid): RR2-10.2196/resprot.6993., (©Ronald W Gimbel, Lior M Rennert, Paul Crawford, Jeanette R Little, Khoa Truong, Joel E Williams, Sarah F Griffin, Lu Shi, Liwei Chen, LingLing Zhang, Jennie B Moss, Robert C Marshall, Karen W Edwards, Kristy J Crawford, Marie Hing, Amanda Schmeltz, Brandon Lumsden, Morgan Ashby, Elizabeth Haas, Kelly Palazzo. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 26.05.2020.)

Background: The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow., Objective: We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities., Methods: This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics., Results: We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016., Conclusions: The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting., Trial Registration: ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei)., (©Ronald Gimbel, Lu Shi, Joel E Williams, Cheryl J Dye, Liwei Chen, Paul Crawford, Eric A Shry, Sarah F Griffin, Karyn O Jones, Windsor W Sherrill, Khoa Truong, Jeanette R Little, Karen W Edwards, Marie Hing, Jennie B Moss. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.03.2017.)