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Enhancing mHealth Technology to Activate Chronic Care Patients

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Care Environment (MHCE)
Sponsored by
Clemson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mike O'Callaghan Federal Medical Center
  • Madigan Army Medicall Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient Activation Measure (PAM)
PAM is a validated survey measure of patient activation

Secondary Outcome Measures

Glycosylated hemoglobin (HbA1C)
HbA1c results documented on three occasions
Low-density Lipoprotein (LDL)
LDL results documented on three occasions
High-density Lipoprotein (HDL)
HDL results documented on three occasions
Abdominal circumference
Abdominal measures taken on three occasions
Blood pressure
Collected in clinic and daily by the patient
Summary of Diabetes Self-Care Activities (SDSCA)
Validated survey measure of diabetes self-care activities

Full Information

First Posted
September 30, 2016
Last Updated
August 4, 2020
Sponsor
Clemson University
Collaborators
Madigan Army Medical Center, U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT02949037
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
October 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clemson University
Collaborators
Madigan Army Medical Center, U.S. Army Medical Research and Development Command

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mobile Health Care Environment (MHCE)
Other Intervention Name(s)
mCare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Activation Measure (PAM)
Description
PAM is a validated survey measure of patient activation
Time Frame
Every 3 months during the 12-month trial
Secondary Outcome Measure Information:
Title
Glycosylated hemoglobin (HbA1C)
Description
HbA1c results documented on three occasions
Time Frame
Every 4 months during 12-month trial
Title
Low-density Lipoprotein (LDL)
Description
LDL results documented on three occasions
Time Frame
Every 4 months during 12-month trial
Title
High-density Lipoprotein (HDL)
Description
HDL results documented on three occasions
Time Frame
Every 4 months during 12-month trial
Title
Abdominal circumference
Description
Abdominal measures taken on three occasions
Time Frame
Every 4 months during 12-month trial
Title
Blood pressure
Description
Collected in clinic and daily by the patient
Time Frame
Every 4 months plus patient self-measurement during 12 -month trial
Title
Summary of Diabetes Self-Care Activities (SDSCA)
Description
Validated survey measure of diabetes self-care activities
Time Frame
Every 2 weeks during 12-month trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W. Gimbel
Organizational Affiliation
Clemson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mike O'Callaghan Federal Medical Center
City
Nellis Air Force Base
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States
Facility Name
Madigan Army Medicall Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32329438
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.
Results Reference
derived
PubMed Identifier
28264792
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.
Results Reference
derived

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Enhancing mHealth Technology to Activate Chronic Care Patients

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