Asthma Data Innovation Demonstration Project

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162576
• Other study ID #: PH LVL - 40202
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: January 2014

Study information

• Verified date: July 2021
• Source: Reciprocal Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Jefferson County	Louisville	Kentucky

Sponsors (4)

Lead Sponsor	Collaborator
David Van Sickle	Foundation for a Healthy Kentucky, Norton Healthcare Foundation, Owsley Brown Charitable Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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):5 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to study exit, up to 13 months
Secondary	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.	Change from baseline period to study exit (approximately 13 months)
Secondary	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.	Baseline and study exit (approximately 13 months)

External Links

•   Feature by Robert Wood Johnson Foundation