Enhancing mHealth Technology to Activate Chronic Care Patients



Status:Active, not recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:September 2016
End Date:December 31, 2018

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Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients

Multi-site feasibility study designed to assist type-2 diabetes patients in self-care
activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood pressure
cuffs, glucometers, and activity monitors) for both intervention and control groups. Those in
the intervention group will have the devices linked too a mobile health care environment that
provides key benefits that include: device data trending, reinforcing tailored behavioral
messages, and enhanced communication with the clinic.

Multi-site phased study, conducted within the Military Health System that includes a
user-centered design phase and a patient centered medical home (PCMH)-based feasibility
trial.

In Phase I the investigators will assess both patient and clinician preferences and usability
regarding the enhancement of the enabling technology capabilities for Type 2 diabetes chronic
self-care management. The data from the experience will be coded and analyzed by the research
team and the technology will be adapted accordingly before Phase II.

Phase II research is a single-blinded 12-month feasibility study that seeks to include the
enabling technology to support diabetes self-care management with tailored behavioral
messaging aimed at reinforcing and encouraging self-care behavior based on patients'
readiness. We have included safety thresholds that alert patients and clinical team under
certain conditions.

Inclusion Criteria:

- Men and women age 18 years or older,

- Ability to understand and read English,

- Be empanelled to one of the target PCMH sites, and

- Diagnosed with type 2 diabetes.

Exclusion Criteria:

- pregnant women,

- non-English speaking patients,

- receiving hospice care,

- active cancer and treatment with chemotherapy or radiation therapy,

- taking Coumadin,

- recipient of gastric bypass or similar procedure,

- diagnosis of uncontrolled hypothyroidism,

- known Cushing's syndrome,

- being treated with oral steroids,

- known liver disease,

- current diagnosis of cognitive impairments which would interfere with use of
technology,

- congestive heart failure New York Heart Association class 3 or 4,

- inability to use a mobile device due to cognitive or physical impairments, and

- PAM® score = 4 during initial screening.
We found this trial at
2
sites
4700 North Las Vegas Boulevard
Nellis Air Force Base, Nevada 89191
Phone: 702-653-2113
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from
Nellis Air Force Base, NV
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9040 Jackson Ave
Tacoma, Washington 98431
Phone: 253-968-6047
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Tacoma, WA
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