Clinical trial NCT02949037: Enhancing mHealth Technology to Activate Chronic Care Patients
Official title: Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: Madigan Army Medical Center
name: U.S. Army Medical Research and Development Command
First posted: 2016-10-31
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Activation Measure (PAM)
timeFrame: Every 3 months during the 12-month trial
Secondary outcomes:
measure: Glycosylated hemoglobin (HbA1C)
timeFrame: Every 4 months during 12-month trial
measure: Low-density Lipoprotein (LDL)
timeFrame: Every 4 months during 12-month trial
measure: High-density Lipoprotein (HDL)
timeFrame: Every 4 months during 12-month trial
measure: Abdominal circumference
timeFrame: Every 4 months during 12-month trial
measure: Blood pressure
timeFrame: Every 4 months plus patient self-measurement during 12 -month trial
measure: Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: Every 2 weeks during 12-month trial
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Federal Medical Center
state: Nevada
city: Tacoma
country: United States
facility: Madigan Army Medicall Center
state: Washington
Study officials:
affiliation: Clemson University
name: Ronald W. Gimbel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gimbel RW, Rennert LM, Crawford P, Little JR, Truong K, Williams JE, Griffin SF, Shi L, Chen L, Zhang L, Moss JB, Marshall RC, Edwards KW, Crawford KJ, Hing M, Schmeltz A, Lumsden B, Ashby M, Haas E, Palazzo K. Enhancing Patient Activation and Self-Management Activities in Patients With Type 2 Diabetes Using the US Department of Defense Mobile Health Care Environment: Feasibility Study. J Med Internet Res. 2020 May 26;22(5):e17968. doi: 10.2196/17968.
citation: Gimbel R, Shi L, Williams JE, Dye CJ, Chen L, Crawford P, Shry EA, Griffin SF, Jones KO, Sherrill WW, Truong K, Little JR, Edwards KW, Hing M, Moss JB. Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol. JMIR Res Protoc. 2017 Mar 6;6(3):e38. doi: 10.2196/resprot.6993.