Enhancing mHealth Technology to Activate Chronic Care Patients

Clemson University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Mobile Health Care Environment (MHCE)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02949037

IRB2015-234 (PPN 2015000085)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

229 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Mobile Health Care Environment (MHCE)

Control

No Intervention group

Description:

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.