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Completed

NCT Number: NCT02162576

Asthma Data Innovation Demonstration Project

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.

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Key information

Conditions

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

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson County

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Propeller Health intervention

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.

Other names: Asthmapolis

Primary outcomes

  1. Change in Rescue Inhaler Actuations/Person/Day

    Time frame: Change from baseline to study exit, up to 13 months

    The Propeller Health sensor permits the capture of objective time and location data on each actuation of the rescue inhaler. The mean number of rescue inhaler events per participant per day will be assessed for each day in the study, and the difference between the baseline month and all subsequent months will be evaluated.

Secondary outcomes

  1. Percent Change in the Proportion of Participants With an Asthma-free Day

    Time frame: Change from baseline period to study exit (approximately 13 months)

    Each 24-hour period without an actuation of a rescue inhaler was counted as an asthma-free day. The proportion of participants with an asthma-free day was calculated for each day of the program, with the denominator including all active participants on that day of the program, defined as those that synced after that date.

  2. Percent Change in the Proportion of Participants With Well-controlled Asthma

    Time frame: Baseline and study exit (approximately 13 months)

    Daily control status was assessed based upon the timing and frequency of SABA actuations according to NAEPP guidelines. The proportion of the study cohort defined as well controlled, not well controlled and poorly controlled was assessed weekly throughout the program.

Sponsors and collaborators

Lead sponsor

David Van Sickle

Industry

Collaborators

  • Foundation for a Healthy Kentucky
  • Norton Healthcare Foundation
  • Owsley Brown Charitable Foundation

Registry information

Official study title

Asthma Data Innovation Demonstration Project: Impact of a Mobile Health, Sensor-driven Asthma Management Platform on Asthma Symptoms, Control and Self-management

Acronym: ADID

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2014
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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