Trial Outcomes & Findings for Promoting Risk Reduction Among Young Adults With Asthma During Wildfire Smoke Events (TRAK) (NCT NCT04724733)

Last Updated: 2023-04-28

Results Overview

Lung function indicates future risk of adverse outcomes and is regularly monitored in people with asthma. Spirometry is used to objectively measure and monitor airway obstruction by blowing into a machine and measuring forced expiratory volume (FEV1), forced vital capacity (FVC), and their ratio (FEV1/FVC). A low FEV1, \<60% predicted, is a potentially modifiable independent risk factor for severe asthma exacerbations. Portable spirometers, that are used by patients independently and connect to smartphones, have been validated against conventional spirometry performed by specialists in clinical settings.

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Control The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app.	Smoke Sense Smoke Sense: Smoke Sense is a smartphone application (app). Smoke Sense participants will be asked to establish a profile which includes demographics, baseline health information and current beliefs about smoke and air pollution. In the Symptoms \& Smoke Observations tab, participants are asked to report their weekly observations of smoke, health symptoms, and exposure reduction behaviors. In the Fire \& Smoke Near Me tab, participants review the most recent AQ data measured at an AQ monitoring sites. Participants are asked to complete the AQ 101 module which test knowledge of AQ facts and provides correct answers. Badges are awarded for accomplishments within the app to promote certain desired behaviors: completing a user profile, launching the app weekly to check local AQ, reporting smoke and symptom observations, expanding AQ knowledge with AQ lessons, and exploring the map. Finally, participants can engage with other users by viewing cumulative statistics of symptoms and smoke observations.	Smoke Sense Plus Smoke Sense Plus: Participants randomized to the Smoke Sense Plus intervention will be asked to do everything that the Smoke Sense intervention group does on a weekly basis, as well as: 1) Receive weekly push notifications that remind them to, for example, review their asthma action plan, refill any expired medications, take their daily controller medication, identify a clean air space in their home and community, 2) Monitor their lung function weekly via mobile spirometry, and 3) Subscribe to a social network to share strategies to minimize exposure.
Overall Study STARTED	22	22	23
Overall Study 4 Weeks	22	21	23
Overall Study COMPLETED	21	21	22
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app.	Smoke Sense Smoke Sense: Smoke Sense is a smartphone application (app). Smoke Sense participants will be asked to establish a profile which includes demographics, baseline health information and current beliefs about smoke and air pollution. In the Symptoms \& Smoke Observations tab, participants are asked to report their weekly observations of smoke, health symptoms, and exposure reduction behaviors. In the Fire \& Smoke Near Me tab, participants review the most recent AQ data measured at an AQ monitoring sites. Participants are asked to complete the AQ 101 module which test knowledge of AQ facts and provides correct answers. Badges are awarded for accomplishments within the app to promote certain desired behaviors: completing a user profile, launching the app weekly to check local AQ, reporting smoke and symptom observations, expanding AQ knowledge with AQ lessons, and exploring the map. Finally, participants can engage with other users by viewing cumulative statistics of symptoms and smoke observations.	Smoke Sense Plus Smoke Sense Plus: Participants randomized to the Smoke Sense Plus intervention will be asked to do everything that the Smoke Sense intervention group does on a weekly basis, as well as: 1) Receive weekly push notifications that remind them to, for example, review their asthma action plan, refill any expired medications, take their daily controller medication, identify a clean air space in their home and community, 2) Monitor their lung function weekly via mobile spirometry, and 3) Subscribe to a social network to share strategies to minimize exposure.
Overall Study Lost to Follow-up	1	1	1

Baseline Characteristics

Promoting Risk Reduction Among Young Adults With Asthma During Wildfire Smoke Events (TRAK)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=22 Participants The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app.	Smoke Sense n=22 Participants Smoke Sense: Smoke Sense is a smartphone application (app). Smoke Sense participants will be asked to establish a profile which includes demographics, baseline health information and current beliefs about smoke and air pollution. In the Symptoms \& Smoke Observations tab, participants are asked to report their weekly observations of smoke, health symptoms, and exposure reduction behaviors. In the Fire \& Smoke Near Me tab, participants review the most recent AQ data measured at an AQ monitoring sites. Participants are asked to complete the AQ 101 module which test knowledge of AQ facts and provides correct answers. Badges are awarded for accomplishments within the app to promote certain desired behaviors: completing a user profile, launching the app weekly to check local AQ, reporting smoke and symptom observations, expanding AQ knowledge with AQ lessons, and exploring the map. Finally, participants can engage with other users by viewing cumulative statistics of symptoms and smoke observations.	Smoke Sense Plus n=23 Participants Smoke Sense Plus: Participants randomized to the Smoke Sense Plus intervention will be asked to do everything that the Smoke Sense intervention group does on a weekly basis, as well as: 1) Receive weekly push notifications that remind them to, for example, review their asthma action plan, refill any expired medications, take their daily controller medication, identify a clean air space in their home and community, 2) Monitor their lung function weekly via mobile spirometry, and 3) Subscribe to a social network to share strategies to minimize exposure.	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=39 Participants	22 Participants n=41 Participants	23 Participants n=35 Participants	67 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Age, Continuous	21.9 years STANDARD_DEVIATION 2.5 • n=39 Participants	21.8 years STANDARD_DEVIATION 2.81 • n=41 Participants	21.9 years STANDARD_DEVIATION 2.05 • n=35 Participants	21.9 years STANDARD_DEVIATION 2.42 • n=31 Participants
Sex: Female, Male Female	18 Participants n=39 Participants	16 Participants n=41 Participants	17 Participants n=35 Participants	51 Participants n=31 Participants
Sex: Female, Male Male	4 Participants n=39 Participants	6 Participants n=41 Participants	6 Participants n=35 Participants	16 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	0 Participants n=41 Participants	2 Participants n=35 Participants	3 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	1 Participants n=41 Participants	0 Participants n=35 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	17 Participants n=39 Participants	17 Participants n=41 Participants	18 Participants n=35 Participants	52 Participants n=31 Participants
Race (NIH/OMB) More than one race	3 Participants n=39 Participants	3 Participants n=41 Participants	2 Participants n=35 Participants	8 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants	3 Participants n=31 Participants
Region of Enrollment United States	22 participants n=39 Participants	22 participants n=41 Participants	23 participants n=35 Participants	67 participants n=31 Participants
asthma control test	20.3 units on a scale STANDARD_DEVIATION 3.4 • n=39 Participants	20.7 units on a scale STANDARD_DEVIATION 1.8 • n=41 Participants	20.3 units on a scale STANDARD_DEVIATION 2.2 • n=35 Participants	20.4 units on a scale STANDARD_DEVIATION 2.5 • n=31 Participants
mean percent predicted FEV1	89.8 percent STANDARD_DEVIATION 20.1 • n=39 Participants	96.2 percent STANDARD_DEVIATION 14.1 • n=41 Participants	93.4 percent STANDARD_DEVIATION 18.6 • n=35 Participants	93.1 percent STANDARD_DEVIATION 17.8 • n=31 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Control n=13 Participants The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app.	Smoke Sense n=7 Participants Smoke Sense: Smoke Sense is a smartphone application (app). Smoke Sense participants will be asked to establish a profile which includes demographics, baseline health information and current beliefs about smoke and air pollution. In the Symptoms \& Smoke Observations tab, participants are asked to report their weekly observations of smoke, health symptoms, and exposure reduction behaviors. In the Fire \& Smoke Near Me tab, participants review the most recent AQ data measured at an AQ monitoring sites. Participants are asked to complete the AQ 101 module which test knowledge of AQ facts and provides correct answers. Badges are awarded for accomplishments within the app to promote certain desired behaviors: completing a user profile, launching the app weekly to check local AQ, reporting smoke and symptom observations, expanding AQ knowledge with AQ lessons, and exploring the map. Finally, participants can engage with other users by viewing cumulative statistics of symptoms and smoke observations.	Smoke Sense Plus n=17 Participants Smoke Sense Plus: Participants randomized to the Smoke Sense Plus intervention will be asked to do everything that the Smoke Sense intervention group does on a weekly basis, as well as: 1) Receive weekly push notifications that remind them to, for example, review their asthma action plan, refill any expired medications, take their daily controller medication, identify a clean air space in their home and community, 2) Monitor their lung function weekly via mobile spirometry, and 3) Subscribe to a social network to share strategies to minimize exposure.
Lung Function, Specifically % Predicted Mean FEV1	92.9 percentage of predicted Standard Deviation 16	95.6 percentage of predicted Standard Deviation 17.2	88.6 percentage of predicted Standard Deviation 17.2

PRIMARY outcome

Timeframe: 8 weeks

The Asthma Control Test (ACT) measures the frequency of shortness of breath and general asthma symptoms, use of rescue medications, effect of asthma on daily functioning, and an overall self-assessment of asthma control via self-report. It has 5 items, is based on self report of symptoms and daily functioning and has a response scale that ranges from 5 (poor control) to 25 (complete control). ACT score \>19 indicates well-controlled (versus 19 or \< poorly controlled) asthma. The Minimally Important Difference (MID) is 3 points between two groups or for changes over time.

Outcome measures

Outcome measures
Measure	Control n=13 Participants The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app.	Smoke Sense n=7 Participants Smoke Sense: Smoke Sense is a smartphone application (app). Smoke Sense participants will be asked to establish a profile which includes demographics, baseline health information and current beliefs about smoke and air pollution. In the Symptoms \& Smoke Observations tab, participants are asked to report their weekly observations of smoke, health symptoms, and exposure reduction behaviors. In the Fire \& Smoke Near Me tab, participants review the most recent AQ data measured at an AQ monitoring sites. Participants are asked to complete the AQ 101 module which test knowledge of AQ facts and provides correct answers. Badges are awarded for accomplishments within the app to promote certain desired behaviors: completing a user profile, launching the app weekly to check local AQ, reporting smoke and symptom observations, expanding AQ knowledge with AQ lessons, and exploring the map. Finally, participants can engage with other users by viewing cumulative statistics of symptoms and smoke observations.	Smoke Sense Plus n=17 Participants Smoke Sense Plus: Participants randomized to the Smoke Sense Plus intervention will be asked to do everything that the Smoke Sense intervention group does on a weekly basis, as well as: 1) Receive weekly push notifications that remind them to, for example, review their asthma action plan, refill any expired medications, take their daily controller medication, identify a clean air space in their home and community, 2) Monitor their lung function weekly via mobile spirometry, and 3) Subscribe to a social network to share strategies to minimize exposure.
Asthma Control Test	22.4 score on a scale Standard Deviation 1.9	21 score on a scale Standard Deviation 4	21.5 score on a scale Standard Deviation 2.3

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smoke Sense

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smoke Sense Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Postma, Professor, Associate Dean for Research

Washington State University College of Nursing

Phone: 509-324-7287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place