Asthma Data Innovation Demonstration Project

NCT ID: NCT02162576

Last Updated: 2021-07-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-01-31

Brief Summary

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Propeller Health is collaborating with the City of Louisville and other local partners to carry out a focused demonstration project that will evaluate the effectiveness of the Propeller Health approach to asthma management while exploring means to use real-time data on asthma exacerbations in a public health setting. The Asthma Data Innovation Demonstration Project (ADID) will use wireless sensor technology to develop spatial and temporal data on the use of rescue inhalers by 120 study subjects with asthma in the Louisville metropolitan area. Propeller Health will process these data to support two general strategies.

Asthma self management: Rescue inhaler actuation data will be compiled into individualized feedback reports to support asthma self management. Propeller Health will combine information on individual rescue inhaler actuations with evidence-based asthma management tips into real-time reports that will be provided to subjects. ADID staff will evaluate any resulting improvements in asthma control that may be based on this information. Subjects may share reports with their healthcare providers.

Municipal purposes: The second strategy is to provide aggregated and de-identified, spatial and temporal asthma rescue inhaler actuation data to City personnel and authorized public health researchers in Louisville. These data will show the times and locations of the use of rescue inhalers by the 120 study subjects throughout the greater Louisville area. ADID staff will work with City personnel and researchers to investigate how this unprecedented level of detailed information on exacerbations can be used best to increase public awareness of environmental triggers while supporting public health surveillance efforts around respiratory diseases.

Detailed Description

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Conditions

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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propeller Health intervention group

All participants attached the Propeller sensor to their SABA medications and tracked the time and location of use for up to 13 months, to capture seasonal variation in medication use, symptoms and environmental triggers. The first 30-day run-in period served as a control period to assess levels of asthma control and SABA use; subject actuations were tracked, but participants and physicians did not receive their data or feedback. After the run-in period, participants received the full intervention for 12 months (see intervention for description).

Group Type OTHER

Propeller Health intervention

Intervention Type DEVICE

The Propeller intervention works through the provision of information to patients and their providers. With the Propeller sensor device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp and geographic location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via mobile apps, online dashboards, email reports and text message reminders that are returned to the patient. This communication provides an ongoing assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management. Each participant was invited to share reports with his or her healthcare provider, but this was not required.

Interventions

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Propeller Health intervention

The Propeller intervention works through the provision of information to patients and their providers. With the Propeller sensor device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp and geographic location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via mobile apps, online dashboards, email reports and text message reminders that are returned to the patient. This communication provides an ongoing assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management. Each participant was invited to share reports with his or her healthcare provider, but this was not required.

Intervention Type DEVICE

Other Intervention Names

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Asthmapolis

Eligibility Criteria

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Inclusion Criteria

* Self-reported provider diagnosis of asthma
* Prescription for Short Acting Beta Agonist (SABA) at study intake

Exclusion Criteria

* Subject is under the age of 5 at the beginning of the study
* Subject does not speak English
* Subject does not have access to the Internet or email to receive reports
* Subject has substantial co-morbidity (self-reported provider diagnosis of COPD)
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for a Healthy Kentucky

OTHER

Sponsor Role collaborator

Norton Healthcare Foundation

OTHER

Sponsor Role collaborator

Owsley Brown Charitable Foundation

UNKNOWN

Sponsor Role collaborator

David Van Sickle

INDUSTRY

Sponsor Role lead

Responsible Party

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David Van Sickle

CEO

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Van Sickle, PhD

Role: PRINCIPAL_INVESTIGATOR

Propeller Health

Locations

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Jefferson County

Louisville, Kentucky, United States

Site Status

Countries

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United States

References

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Barrett M, Combs V, Su JG, Henderson K, Tuffli M; AIR Louisville Collaborative; AIR Louisville Collaborative. AIR Louisville: Addressing Asthma With Technology, Crowdsourcing, Cross-Sector Collaboration, And Policy. Health Aff (Millwood). 2018 Apr;37(4):525-534. doi: 10.1377/hlthaff.2017.1315.

Reference Type RESULT
PMID: 29608361 (View on PubMed)

Barrett MA, Humblet O, Marcus JE, Henderson K, Smith T, Eid N, Sublett JW, Renda A, Nesbitt L, Van Sickle D, Stempel D, Sublett JL. Effect of a mobile health, sensor-driven asthma management platform on asthma control. Ann Allergy Asthma Immunol. 2017 Nov;119(5):415-421.e1. doi: 10.1016/j.anai.2017.08.002.

Reference Type RESULT
PMID: 29150069 (View on PubMed)

Other Identifiers

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PH LVL - 40202

Identifier Type: -

Identifier Source: org_study_id

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