Enhancing mHealth Technology to Activate Chronic Care Patients

Clemson University229 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

229

Conditions

Diabetes Mellitus, Type 2

Interventions

Mobile Health Care Environment (MHCE)OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, United States

Madigan Army Medicall Center

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Patient Activation Measure (PAM)

PAM is a validated survey measure of patient activation

Time frame: Every 3 months during the 12-month trial

Secondary Outcomes

Glycosylated hemoglobin (HbA1C)

HbA1c results documented on three occasions

Time frame: Every 4 months during 12-month trial

Low-density Lipoprotein (LDL)

LDL results documented on three occasions

Time frame: Every 4 months during 12-month trial

High-density Lipoprotein (HDL)

HDL results documented on three occasions

Time frame: Every 4 months during 12-month trial

Abdominal circumference

Abdominal measures taken on three occasions

Time frame: Every 4 months during 12-month trial

Blood pressure

Collected in clinic and daily by the patient

Time frame: 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

Time frame: Every 2 weeks during 12-month trial

Data from ClinicalTrials.gov

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