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Completed

NCT Number: NCT02949037

Enhancing mHealth Technology 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mike O'Callaghan Federal Medical Center, Nellis Air Force Base, Nevada, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Health Care Environment (MHCE)

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.

Other names: mCare

Primary outcomes

  1. Patient Activation Measure (PAM)

    Time frame: Every 3 months during the 12-month trial

    PAM is a validated survey measure of patient activation

Secondary outcomes

  1. Glycosylated hemoglobin (HbA1C)

    Time frame: Every 4 months during 12-month trial

    HbA1c results documented on three occasions

  2. Low-density Lipoprotein (LDL)

    Time frame: Every 4 months during 12-month trial

    LDL results documented on three occasions

  3. High-density Lipoprotein (HDL)

    Time frame: Every 4 months during 12-month trial

    HDL results documented on three occasions

  4. Abdominal circumference

    Time frame: Every 4 months during 12-month trial

    Abdominal measures taken on three occasions

  5. Blood pressure

    Time frame: Every 4 months plus patient self-measurement during 12 -month trial

    Collected in clinic and daily by the patient

  6. Summary of Diabetes Self-Care Activities (SDSCA)

    Time frame: Every 2 weeks during 12-month trial

    Validated survey measure of diabetes self-care activities

Sponsors and collaborators

Lead sponsor

Clemson University

Other

Collaborators

  • Madigan Army Medical Center
  • U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2016
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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