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Assessing the Use of Mobile Technology in Adult Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103880
Recruitment Status : Unknown
Verified March 2017 by CoheroHealth.
Recruitment status was:  Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
CoheroHealth

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Device: mHealth Asthma Adherence System Device: Remote Mobile Pulmonary Function Testing Device: Remote Mobile Peak Flow Capture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single arm observation of mobile application used to enable medication adherence tracking with two parallel arms to simultaneously assess usability of two lung function capture techniques.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Use of Mobile Technology in Adult Asthma Patients: A Remote Observational Study
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Medication Adherence and Pulmonary Function Tests 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.

Experimental: Medication Adherence and Peak Flow Measurements 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 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.




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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).

  2. Asthma Control [ Time Frame: 6 months ]
    Frequency of Rescue Medication Use

  3. Asthma Control [ Time Frame: 6 months ]
    Healthcare utilization related to Asthma (including self-report of ED visits and hospitalizations).

  4. Medication Adherence [ Time Frame: 6 months ]
    Real-time medication usage as monitored by bluetooth-enabled sensor devices

  5. Medication Adherence [ Time Frame: 6 months ]
    Real-time medication usage as monitored by self report via MMAS (Modified Morisky Adherence Scale)

  6. Quality of Life [ Time Frame: 6 months ]
    EuroQol-5D Questionnaire

  7. Lung Function [ Time Frame: 6 months ]
    Lung Function metrics as measured by Peak Flow

  8. Lung Function [ Time Frame: 6 months ]
    Lung Function metrics as measured by Forced Expiratory Volume in 1 second (FEV1)

  9. Lung Function [ Time Frame: 6 months ]
    Lung Function metrics as measured by Forced Vital Capacity (FVC)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103880


Contacts
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Contact: Anne Tam, MPH anne@coherohealth.com

Locations
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United States, New York
Cohero Health, Inc. Recruiting
New York, New York, United States, 10017
Sponsors and Collaborators
CoheroHealth
Investigators
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Study Director: Anne Tam, MPH Cohero Health, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CoheroHealth
ClinicalTrials.gov Identifier: NCT03103880    
Other Study ID Numbers: 2017_Observational_Study_1.0
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by CoheroHealth:
Patient Adherence
Mobile Applications
Mobile Health
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases