Improving Health in Diabetes Project

Diabetes mellitus (DM) is a growing public health problem highly amenable to prevention and
health promotion interventions. Over 26 million people are diagnosed with diabetes, and an
estimated 79 million people have pre-diabetes (1). Physical inactivity, poor eating habits,
obesity and smoking are common risk factors for multiple chronic diseases, including DM, and
are associated with premature deaths in the United States (2). Traditional interventions for
diabetes emphasize education and typically do not address patient-generated health data (3).
MI is a counseling tool to improve self-efficacy and support behavioral changes that has been
used successfully in treatment of addictions and chronic conditions including diabetes (4-6).
MI focuses on enhancing goal-setting skills by encouraging focus on manageable steps to
improve overall health, establishing reasonable goals, and managing barriers and obstacles to
goal attainment. Mobile health (mHealth) technology can be used to allow bi-directional,
timely communication of data and tailored feedback between the patient and health care team;
thus mHealth has the potential to change an individual' health behavior and prevent factors
that lead to disease (7). This proposal tests the effectiveness of nurse coaches and the
mHealth platform as resources to patients. Specifically, the investigators will test a mobile
technology-enabled nurse coaching intervention as a means to engage and empower patients to
set their own personal goals to address lifestyle and behavioral changes to better manage
their diabetes and comorbidities. The addition of a wireless sensing wearable device to
monitor participant activities (physical activity, energy expenditure and sleep quality) will
allow the investigators to perform meaningful analysis of patient-generated health data and
provide tailored feedback to motivate the patient to reach personal goals. The investigators
will achieve this project through the following Specific Aims:

Specific Aim 1: To evaluate the effectiveness of the P2E2T2 program on diabetes management as
measured by the following outcomes: 1) quality of life (QOL); 2) self-efficacy; 3) readiness
to change; and 4) clinically relevant outcomes.

Specific Aim 2: Compare specific health and fitness outcomes of individuals participating in
each study arm.

This study is a randomized, controlled trial with two groups: 1) Usual care (Care
Coordination); and 2) the Patient and Provider Engagement and Empowerment Through Technology
(P2E2T2) program - nurse coaching paired with mobile sensor technology to provide targeted
feedback of patient-generated, real-world community physical activity and sleep quality data
to the nurse coach, participants, and primary care providers to improve self-management of
diabetes. Participants will be recruited from the UC Davis Primary Care Clinics network.
After enrollment in the study, those randomized to receive the intervention will interact
with their nurse coach through mobile technologies by telephone, face-to-face
videoconference, or by text/e-mail through the secure mHealth dashboard platform established
for communication and transfer of data. The investigators expect to enroll at least 150
patients in each of the intervention and control arms. This sample size will be sufficient to
detect differences between the two groups. Even under the conservative assumption that design
effects and dropout rates may result in a reduced sample size of 100 per treatment group, the
study will still have at least 80% power to detect the specified clinically important effect
size. Based on a previous study of nurse coaching using MI to improve disease self-management
(8), the investigators found improvement in self-efficacy scores significantly higher in the
intervention group compared to the control group. Data will be collected from participants at
three time points: 1) baseline data at time of recruitment; 2) 3 months (coinciding with the
program completion); and 3) 9 months (selected to assess sustained effects of the
intervention). At baseline, in addition to outcomes, all participants will complete a
demographic survey which will include age, gender, race/ethnicity, education level, income
level and insurance type and health history using the Charlson Comorbidity Index which
includes common chronic conditions. All data for the study will be collected by the research
coordinator and entered into the REDCap (Research Electronic Data Capture) system housed in
the servers managed by UC Davis Clinical and Translational Science Center (CTSC) (9).

Inclusion Criteria:

1. At least 18 years of age

2. Diagnosis of Diabetes Mellitus (type 2)

3. Receiving care at one of the UC Davis Primary Care participating clinics
(hospital-based Primary Care Clinic, the Folsom Primary Care Clinic)

4. Able to read, write, and speak English

5. Has access to a telephone and computing device

6. Has had experience with use of a mobile smartphone & applications

7. HgbA1C over 6.5%

Exclusion Criteria:

1. Does not have Diabetes Mellitus

2. Primary language is not English

3. Pregnant women

4. Those that not have access to a telephone or computing device

5. Has a HgbA1C value under 6.5%