Assessing the Use of Mobile Technology in Adult Asthma Patients

Overview

The purpose of the study is to determine the feasibility and acceptability of at-home use of the Cohero mHealth (mobile health) technology, which consists of a Bluetooth Low Energy connected medication-use sensor (HerotrackerTM) that monitors at-home medication use, mobile application (BreatheSmart) that sends real-time reminders, and mobile spirometer (mSpirometer) that measures lung function, through a virtual observational study format in order to improve patient engagement with the platform for sustainable use and motivate subjects to self-manage their disease.

Full Title of Study: “Assessing the Use of Mobile Technology in Adult Asthma Patients: A Remote Observational Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2018

Interventions

  • Device: mHealth Asthma Adherence System
    • This Intervention includes the use of the mobile application and connected sensors to track adherence and engage patients in their care.
  • Device: Remote Mobile Pulmonary Function Testing
    • This intervention includes remote patient monitoring of lung function using a connected spirometer used to capture pulmonary function testing (PFTs) monthly.
  • Device: Remote Mobile Peak Flow Capture
    • This intervention includes remote patient monitoring of lung function using a connected spirometer used to capture peak flow and FEV1 metrics weekly.

Arms, Groups and Cohorts

  • Experimental: Medication Adherence and Pulmonary Function Tests
  • Experimental: Medication Adherence and Peak Flow Measurements

Clinical Trial Outcome Measures

Primary Measures

  • Usability of Platform
    • Time Frame: 6 months
    • Backend measures of subjects’ use of the sensor and mobile app and ability of platform to sync and upload data, Usability Questionnaire
  • Acceptability of Platform
    • Time Frame: 6 months
    • Acceptability questionnaire including subjects’ opinion of the platform and its features and open-ended discussions with participants

Secondary Measures

  • Asthma Control
    • Time Frame: 6 months
    • Asthma Control Test, Frequency of Rescue Medication Use, Healthcare utilization related to Asthma (including self-report of ED visits and hospitalizations).
  • Asthma Control
    • Time Frame: 6 months
    • Frequency of Rescue Medication Use
  • Asthma Control
    • Time Frame: 6 months
    • Healthcare utilization related to Asthma (including self-report of ED visits and hospitalizations).
  • Medication Adherence
    • Time Frame: 6 months
    • Real-time medication usage as monitored by bluetooth-enabled sensor devices
  • Medication Adherence
    • Time Frame: 6 months
    • Real-time medication usage as monitored by self report via MMAS (Modified Morisky Adherence Scale)
  • Quality of Life
    • Time Frame: 6 months
    • EuroQol-5D Questionnaire
  • Lung Function
    • Time Frame: 6 months
    • Lung Function metrics as measured by Peak Flow
  • Lung Function
    • Time Frame: 6 months
    • Lung Function metrics as measured by Forced Expiratory Volume in 1 second (FEV1)
  • Lung Function
    • Time Frame: 6 months
    • Lung Function metrics as measured by Forced Vital Capacity (FVC)

Participating in This Clinical Trial

Inclusion Criteria

  • Ability to provide written informed consent
  • Male and female adults (aged ≥ 18 years)
  • Diagnosis of asthma for at least 6 months
  • ICS (inhaled corticosteroid) use for at least 3 months
  • Use of a pressurized metered dose inhaler (pMDI) compatible with the Cohero mHealth HerotrackerTM
  • Possess a compatible smartphone (iOS 8.0 or higher and Android 4.3 or higher)

Exclusion Criteria

  • Currently pregnant or planning to become pregnant during the study period
  • Primary language other than English (BreatheSmart mobile app is currently available only in English)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CoheroHealth
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne Tam, MPH, Study Director, Cohero Health, Inc.
  • Overall Contact(s)
    • Anne Tam, MPH, anne@coherohealth.com

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