search
Back to results

Asthma Data Innovation Demonstration Project (ADID)

Primary Purpose

Asthma, Bronchial Diseases, Respiratory Tract Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propeller Health intervention
Sponsored by
David Van Sickle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, asthma control, healthcare utilization costs, community hotspots, public health research

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jefferson County

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Propeller Health intervention group

Arm Description

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).

Outcomes

Primary Outcome Measures

Change in Rescue Inhaler Actuations/Person/Day
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

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

Full Information

First Posted
June 6, 2014
Last Updated
July 16, 2021
Sponsor
David Van Sickle
Collaborators
Foundation for a Healthy Kentucky, Norton Healthcare Foundation, Owsley Brown Charitable Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT02162576
Brief Title
Asthma Data Innovation Demonstration Project
Acronym
ADID
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Van Sickle
Collaborators
Foundation for a Healthy Kentucky, Norton Healthcare Foundation, Owsley Brown Charitable Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases
Keywords
asthma, asthma control, healthcare utilization costs, community hotspots, public health research

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propeller Health intervention group
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Propeller Health intervention
Other Intervention Name(s)
Asthmapolis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Rescue Inhaler Actuations/Person/Day
Description
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.
Time Frame
Change from baseline to study exit, up to 13 months
Secondary Outcome Measure Information:
Title
Percent Change in the Proportion of Participants With an Asthma-free Day
Description
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.
Time Frame
Change from baseline period to study exit (approximately 13 months)
Title
Percent Change in the Proportion of Participants With Well-controlled Asthma
Description
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.
Time Frame
Baseline and study exit (approximately 13 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Van Sickle, PhD
Organizational Affiliation
Propeller Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson County
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29608361
Citation
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.
Results Reference
result
PubMed Identifier
29150069
Citation
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.
Results Reference
result

Learn more about this trial

Asthma Data Innovation Demonstration Project

We'll reach out to this number within 24 hrs