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Feasibility and Acceptability of the Hailie Monitoring System in Children With Persistent Asthma

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ClinicalTrials.gov Identifier: NCT03648450
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Tregony Simoneau, Connecticut Children's Medical Center

Brief Summary:
The main hypothesis of this study is to see if children and adolescents with poorly controlled asthma will find the Hailie Smart Inhaler electronic monitoring device is feasible and acceptable, and will result in improved medication adherence and asthma control. Preliminary studies indicate that Adherium's Hailie Smart Inhaler can improve medication adherence rates in children with asthma and reduce the number of days of reliever medication used. It also has been shown to reduce missed days of school and hospitalizations due to asthma exacerbations. The Hailie device is a sleeve that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication. It also records use of the controller and rescue inhalers, allowing for parents, physicians, and patients to get a fuller and more accurate picture of their adherence to treatment and severity of disease. With improved adherence, asthma control should improve, resulting in a decreased costs and use of services.

Condition or disease Intervention/treatment
Asthma Other: Hailie Smart Inhaler EMD

Detailed Description:

This study is a prospective cohort study using a pre-/post-design.

The target population consists of children and adolescents 10-18 years old making an ED visit or admitted to the hospital at Connecticut Children's Medical Center for an asthma exacerbation.

All patients will receive two Hailie devices (for controller and rescue inhalers), an App for their smartphone, and a free Hailie subscription, which provides access support and services, and hardware and software updates. Only the children and adolescents involved with the study will have the app on their phone. The parents will not put the Hailie app on their phone. Families will be asked to share the study information with their primary care provider and will be provided with an introductory letter to bring to the provider, if they so choose.

Data collection will begin at enrollment and will continue through the three-month follow-up period. Adherium provides the option of continuous monitoring and data collection beyond study cessation.

Data uploads to the portal occur automatically for patients and caregivers who have installed the Hailie App on their smartphone. Additionally, patients' primary-care providers will receive a password allowing them to track and access participants' dashboard. Patients will bring a letter to their primary-care provider explaining that they are part of a study of Adherium's Hailie device, and receive instructions on how to view the dashboard and adherence data.

At enrollment, participants and parents will complete the Test of Adherence to Inhalers (TAI), Asthma Control Test (ACT) and PedsQL, along with providing baseline medical history/asthma history data and sociodemographic. The TAI, ACT and PedsQL surveys will again be completed one and three months post enrollment information. Additionally, participants will answer an adapted AMDAT survey that will be used to provide acceptability data about the Hailie device.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility and Acceptability of the Hailie Monitoring System in Children With Persistent Asthma
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Hailie Smart Inhaler EMD
All enrolled participants will be given the Hailie Smart Inhaler electronic monitoring device to use for three months to track how often they are using their inhalers either for their regular medication or as a rescue dose.
Other: Hailie Smart Inhaler EMD
Hailie Smart Inhaler electronic monitoring device is a sleeve that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication.




Primary Outcome Measures :
  1. Regular device use at three months [ Time Frame: The information will be collected at three months ]
    This will be assessed by recording the number and percentage of the children and adolescents still using the Hailie Smart Inhaler at three months.


Secondary Outcome Measures :
  1. Acceptability of the Hailie Smartinhaler as determined by the Adolescent Medical Devices Assessment Toolkit (AMDAT) [ Time Frame: Data will be captured at enrollment, one month and three months after enrollment ]
    Acceptability will be determined by phone interview and survey response to the modified Adolescent Medical Devices Assessment Toolkit (AMDAT)

  2. Asthma Control [ Time Frame: ACT will be assessed at enrollment, one month and three months. ]
    Asthma control will be measured by the Asthma Control Test (range 0-25 with a higher score representing better asthma control). Change in ACT score will be assessed between baseline and one month and between baseline and three months. A change of 3 or more is considered a clinically significant change.

  3. Device use at one month [ Time Frame: The information will be collected at one month ]
    This will be assessed by recording the number and percentage of the children and adolescents still using the Hailie Smart Inhaler at one month.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population consists of children and adolescents 10-18 years old making an ED visit or admitted to the hospital at Connecticut Children's Medical Center for an asthma exacerbation.
Criteria

Inclusion Criteria:

  1. Children in the ED or inpatient setting presenting with an asthma exacerbation between 10-18 years old
  2. History of persistent asthma (defined as prescribed a controller medication)
  3. Both the child and primary caregiver/parent have access to a cell phone with an activated number
  4. Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Child or parent has no access to a personal cell phone.
  2. The child has another chronic pulmonary condition (for example, cystic fibrosis)
  3. Having any chronic condition that could affect the child's ability to participate in the study (examples: cancer, autism, or cerebral palsy)
  4. The subject has an inhaler medication besides the following, given these are the current medications compatible with the Hailie device sleeve.

    i. Advair HFA ii. Flovent HFA iii. QVAR HFA iv. Symbicort HFA v. Ventolin HFA vi. ProAir HFA


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): NCT03648450


Contacts
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Contact: Tregony Simoneau, MD 860-545-9440 tsimoneau@connecticutchildrens.org
Contact: Eliza G Baker 860-819-1012 eliza.baker@uconn.edu

Locations
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United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Eliza G Baker    860-819-1012    eliza.baker@uconn.edu   
Principal Investigator: Tregony Simoneau, M.D.         
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
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Study Director: Glenn Flores, MD Connecticut Children's Medical Center

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Responsible Party: Tregony Simoneau, Assistant Professor of Pediatrics, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT03648450     History of Changes
Other Study ID Numbers: Adherium Asthma Study
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
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: No

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