Enhancing mHealth Technology to Activate Chronic Care Patients

NCT ID: NCT02949037

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-10-04

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile Health Care Environment (MHCE)

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

mCare

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Madigan Army Medical Center

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Clemson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald W. Gimbel

Role: PRINCIPAL_INVESTIGATOR

Clemson University

Locations

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, United States

Madigan Army Medicall Center

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32329438 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28264792 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB2015-234 (PPN 2015000085)

Identifier Type: -

Identifier Source: org_study_id