Enhancing mHealth Technology to Activate Chronic Care Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949037
• Other study ID #: IRB2015-234 (PPN 2015000085)
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: October 4, 2019

Study information

• Verified date: August 2020
• Source: Clemson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: October 4, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	Mike O'Callaghan Federal Medical Center	Nellis Air Force Base	Nevada
United States	Madigan Army Medicall Center	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Clemson University	Madigan Army Medical Center, U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Activation Measure (PAM)	PAM is a validated survey measure of patient activation	Every 3 months during the 12-month trial
Secondary	Glycosylated hemoglobin (HbA1C)	HbA1c results documented on three occasions	Every 4 months during 12-month trial
Secondary	Low-density Lipoprotein (LDL)	LDL results documented on three occasions	Every 4 months during 12-month trial
Secondary	High-density Lipoprotein (HDL)	HDL results documented on three occasions	Every 4 months during 12-month trial
Secondary	Abdominal circumference	Abdominal measures taken on three occasions	Every 4 months during 12-month trial
Secondary	Blood pressure	Collected in clinic and daily by the patient	Every 4 months plus patient self-measurement during 12 -month trial
Secondary	Summary of Diabetes Self-Care Activities (SDSCA)	Validated survey measure of diabetes self-care activities	Every 2 weeks during 12-month trial