JMIR Publications

ABSTRACT

Background:

Past mHealth efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, remote collection of biometric data, electronic coaching, e-mail communication, and electronic collection of lifestyle information.

Objective:

To incorporate several of the most promising mHealth technologies aimed at enhancing patient activation and self-care for T2D patients. We aim to address underlying technology needs and gaps, while seeking to influence patient activation and self-care activities.

Methods:

A multi-site phased study, including a user-centered design and a controlled trial, was conducted within the U.S. Military Health System. Phase I assessed preferences regarding enhancement of the enabling technology for T2D self-management care. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the Mobile Health Care Environment (MHCE) intervention (n=123,received enabling mHealth technology and behavioral messages tailored to Patient Activation Measure® (PAM®) level at baseline or the control group (n=117, received equipment but not behavioral messaging, “intervention-lite”). Primary outcome measure was PAM® score. Secondary outcome measures included Summary of Diabetes Self-care Activities (SDSCA) scores and cardiometabolic outcomes. We used Generalized Equations of Estimation to estimate changes in outcomes.

Results:

At baseline, participants had mean age of 62.8 years, mean HbA1c of 7.5%, mean BMI of 32.7, mean duration of diabetes diagnosis of 9.8 years. The majority were male (59.8%). At month 12, the control group saw significantly greater improvements compared to the intervention group in PAM® score (control mean: 7.49, intervention mean: 1.77; P=.007), HbA1c (control mean: -0.53, intervention mean: -0.11; P=.006), and LDL 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. With the exception of patients with the highest level of activation (PAM® 4), all intervention group patients exhibited significant improvements in PAM® score. For patients with the lowest level of activation (PAM® 1), the intervention group saw significantly greater improvement compared to 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 HDL cholesterol levels (control mean: -4.86, intervention mean: 3.56; P<.001). Significant improvements were seen in PAM® score, SDSCA, and waist size for both groups, and diastolic and systolic blood pressure for the control group; between group differences were not statistically significant. Percentage of participants who were engaged with MHCE ≥ 50% of days in each time period was 60.7% (months 0-3), 57.4% (months 3-6), 49.5% (months 6-9), and 42.9% (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. Clinical Trial: ClinicalTrials.gov - NCT02949037. Registered October 31, 2016.