Monitoring Adherence Using Mobile Technology

NCT ID: NCT02617420

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-09-30

Brief Summary

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This study plans to learn more about how children use their asthma medicines. The investigators would like to see if special electronic monitoring devices that connect to smartphones and computers can help children to better manage their asthma

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

All patients will be enrolled in one arm. These patients will have monitoring devices placed on their asthma controller and rescue medication, with data transmitted both to their smartphones and a dashboard accessed by their primary pediatric pulmonary provider.

Propeller Health Monitoring Device

Intervention Type DEVICE

Interventions

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Propeller Health Monitoring Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age 6-17 years and their parents
* either 2 emergency department visits/prednisone bursts in the last 12 months or at least 1 asthma related hospitalization in the last 12 months
* requiring daily controller therapy with either inhaled corticosteroids or combination corticosteroids/long acting beta agonist (LABA).
* Patients using metered dose inhaler therapy would be eligible. Patients may also be on leukotriene antagonists,
* Must be made aware that they will have to read and accept to the terms of the User Agreement prior to enrollment in the study. If they do not agree they will not be able to continue participation. The User agreement will be read agreed to electronically when they begin using the device, however a paper version will be provided at the time of consent upon request.

Exclusion Criteria

* Primary language other than English or Spanish
* Presence of other significant chronic lung disease including cystic fibrosis, interstitial lung disease, tracheostomy status.
* Patients using diskus therapy.
* Patients only on leukotriene antagonists.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stanley Szefler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

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Hoch H, Kempe A, Brinton J, Szefler S. Feasibility of medication monitoring sensors in high risk asthmatic children. J Asthma. 2019 Mar;56(3):270-272. doi: 10.1080/02770903.2018.1446979. Epub 2018 Apr 11. No abstract available.

Reference Type DERIVED
PMID: 29641374 (View on PubMed)

Other Identifiers

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15-0211

Identifier Type: -

Identifier Source: org_study_id

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