Diabetes Mellitus, Type 2
Conditions
Brief summary
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
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.
Interventions
OTHERMobile Health Care Environment (MHCE)
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.
Sponsors
Madigan Army Medical Center
U.S. Army Medical Research and Development Command
Clemson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM) | Every 3 months during the 12-month trial | PAM is a validated survey measure of patient activation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low-density Lipoprotein (LDL) | Every 4 months during 12-month trial | LDL results documented on three occasions |
| High-density Lipoprotein (HDL) | Every 4 months during 12-month trial | HDL results documented on three occasions |
| Glycosylated hemoglobin (HbA1C) | Every 4 months during 12-month trial | HbA1c results documented on three occasions |
| Blood pressure | Every 4 months plus patient self-measurement during 12 -month trial | Collected in clinic and daily by the patient |
| Summary of Diabetes Self-Care Activities (SDSCA) | Every 2 weeks during 12-month trial | Validated survey measure of diabetes self-care activities |
| Abdominal circumference | Every 4 months during 12-month trial | Abdominal measures taken on three occasions |
Countries
United States
Outcome results
None listed