Enhancing mHealth Technology to Activate Chronic Care Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Mobile Health Care Environment (MHCE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Use of (4) bluetooth-enabled biomedical devices (i.e. scale, blood pressure cuff, activity monitor, glucose monitor), for use in self care activities, integrated with the mobile health care environment (MHCE) system. The MHCE system will provide tailored behavioral messages triggered by clinical values and survey responses. | Other: Mobile Health Care Environment (MHCE)<br>* An integrated mobile health system modified to support type 2 diabetes self-care activities. Primary intervention includes visualization and trending of device outcomes AND tailored behavioral messages based on Patient Activation Measure scores.<br>* Other names: mCare;|
| No Intervention: Control<br>Use of (4) bluetooth-enabled biomedical devices (i.e. scale, blood pressure cuff, activity monitor, glucose monitor), for use in self care activities, NOT integrated with the mobile health care environment (MHCE) system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure (PAM) | PAM is a validated survey measure of patient activation | Every 3 months during the 12-month trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin (HbA1C) | HbA1c results documented on three occasions | Every 4 months during 12-month trial | 
| Low-density Lipoprotein (LDL) | LDL results documented on three occasions | Every 4 months during 12-month trial | 
| High-density Lipoprotein (HDL) | HDL results documented on three occasions | Every 4 months during 12-month trial | 
| Abdominal circumference | Abdominal measures taken on three occasions | Every 4 months during 12-month trial | 
| Blood pressure | Collected in clinic and daily by the patient | Every 4 months plus patient self-measurement during 12 -month trial | 
| Summary of Diabetes Self-Care Activities (SDSCA) | Validated survey measure of diabetes self-care activities | Every 2 weeks during 12-month trial |