Enhancing mHealth Technology to Activate Chronic Care Patients

Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Mobile Health Care Environment (MHCE)

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.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Nellis Air Force Base, Nevada, United States, 89191
      • Mike O'Callaghan Federal Medical Center
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medicall Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Mobile 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.; Other Names: mCare
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation Measure (PAM)	PAM is a validated survey measure of patient activation	Every 3 months during the 12-month trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycosylated hemoglobin (HbA1C)	HbA1c results documented on three occasions	Every 4 months during 12-month trial
Low-density Lipoprotein (LDL)	LDL results documented on three occasions	Every 4 months during 12-month trial
High-density Lipoprotein (HDL)	HDL results documented on three occasions	Every 4 months during 12-month trial
Abdominal circumference	Abdominal measures taken on three occasions	Every 4 months during 12-month trial
Blood pressure	Collected in clinic and daily by the patient	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	Every 2 weeks during 12-month trial

Collaborators and Investigators

• Sponsor: Clemson University
• Collaborators: U.S. Army Medical Research and Development Command; Madigan Army Medical Center
• Investigators: Principal Investigator: Ronald W. Gimbel, Clemson University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): October 4, 2019

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB2015-234 (PPN 2015000085)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No