Abstract

BackgroundPast 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.ObjectiveThe 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.MethodsA 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.ResultsThe final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA1c) 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), HbA1c (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 HbA1c (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).ConclusionsOur 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 RegistrationClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037International Registered Report Identifier (IRRID)RR2-10.2196/resprot.6993

Highlights

  • BackgroundType 2 diabetes (T2D) is a chronic disease with high rates of disability, impaired quality of life, and premature death [1,2,3,4,5,6]

  • For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in glycated hemoglobin low-density lipoprotein (LDL) (HbA1c), BMI, and high-density lipoprotein cholesterol levels

  • Significant improvements were seen in AM scores, Summary of Diabetes Self-Care Activities (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

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Summary

Introduction

BackgroundType 2 diabetes (T2D) is a chronic disease with high rates of disability, impaired quality of life, and premature death [1,2,3,4,5,6]. Some of the most promising tools and techniques include regular collection of biometric devices (eg, glucometers, activity monitors [10,11], SMS messaging [10,12,13,14,15,16], secure email communication with clinical teams, and regular reporting of quality-of-life variables [17,18,19,20]). Each of these tools, used alone or in combination, has demonstrated varying degrees of effectiveness. 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

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