Enhancing mHealth Technology to Activate Chronic Care Patients
Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients
1 other identifier
interventional
229
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jul 2017
Typical duration for not_applicable diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2019
CompletedAugust 6, 2020
August 1, 2020
1.8 years
September 30, 2016
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Activation Measure (PAM)
PAM is a validated survey measure of patient activation
Every 3 months during the 12-month trial
Secondary Outcomes (6)
Glycosylated hemoglobin (HbA1C)
Every 4 months during 12-month trial
Low-density Lipoprotein (LDL)
Every 4 months during 12-month trial
High-density Lipoprotein (HDL)
Every 4 months during 12-month trial
Abdominal circumference
Every 4 months during 12-month trial
Blood pressure
Every 4 months plus patient self-measurement during 12 -month trial
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALUse 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.
Control
NO INTERVENTIONUse 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clemson Universitylead
- Madigan Army Medical Centercollaborator
- U.S. Army Medical Research and Development Commandcollaborator
Study Sites (2)
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191, United States
Madigan Army Medicall Center
Tacoma, Washington, 98431, United States
Related Publications (2)
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.
PMID: 32329438DERIVEDGimbel 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.
PMID: 28264792DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald W. Gimbel
Clemson University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2016
First Posted
October 31, 2016
Study Start
July 1, 2017
Primary Completion
April 30, 2019
Study Completion
October 4, 2019
Last Updated
August 6, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share