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Asthma Data Innovation Demonstration Project (ADID)

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: NCT02162576
Recruitment Status : Completed
First Posted : June 12, 2014
Results First Posted : December 26, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Foundation for a Healthy Kentucky
Norton Healthcare Foundation
Owsley Brown Charitable Foundation
Information provided by (Responsible Party):
David Van Sickle, Reciprocal Labs

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Device: Propeller Health intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Asthma Data Innovation Demonstration Project: Impact of a Mobile Health, Sensor-driven Asthma Management Platform on Asthma Symptoms, Control and Self-management
Study Start Date : June 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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).
Device: 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.
Other Name: Asthmapolis




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02162576


Locations
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United States, Kentucky
Jefferson County
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
David Van Sickle
Foundation for a Healthy Kentucky
Norton Healthcare Foundation
Owsley Brown Charitable Foundation
Investigators
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Principal Investigator: David Van Sickle, PhD Propeller Health
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Van Sickle, CEO, Reciprocal Labs
ClinicalTrials.gov Identifier: NCT02162576    
Other Study ID Numbers: PH LVL - 40202
First Posted: June 12, 2014    Key Record Dates
Results First Posted: December 26, 2017
Last Update Posted: January 23, 2018
Last Verified: December 2017
Keywords provided by David Van Sickle, Reciprocal Labs:
asthma
asthma control
healthcare utilization costs
community hotspots
public health research
Additional relevant MeSH terms:
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Asthma
Lung Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Respiratory Tract Diseases
Immune System Diseases