Enhancing mHealth Technology to Activate Chronic Care Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: Mobile Health Care Environment (MHCE)
- Registration Number
- NCT02949037
- Lead Sponsor
- Clemson University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Mobile Health Care Environment (MHCE) 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.
- Primary Outcome Measures
Name Time Method Patient Activation Measure (PAM) Every 3 months during the 12-month trial PAM is a validated survey measure of patient activation
- Secondary Outcome Measures
Name Time Method Glycosylated hemoglobin (HbA1C) Every 4 months during 12-month trial HbA1c results documented on three occasions
Low-density Lipoprotein (LDL) Every 4 months during 12-month trial LDL 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
Abdominal circumference Every 4 months during 12-month trial Abdominal measures taken on three occasions
High-density Lipoprotein (HDL) Every 4 months during 12-month trial HDL results documented on three occasions
Summary of Diabetes Self-Care Activities (SDSCA) Every 2 weeks during 12-month trial Validated survey measure of diabetes self-care activities
Trial Locations
- Locations (2)
Madigan Army Medicall Center
🇺🇸Tacoma, Washington, United States
Mike O'Callaghan Federal Medical Center
🇺🇸Nellis Air Force Base, Nevada, United States