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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04724733
Acronym
TRAK
Enrollment
67
Registered
2021-01-26
Start date
2020-08-06
Completion date
2020-12-14
Last updated
2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Young adult, quality of life, wildfires, risk reduction behavior, smartphone

Brief summary

This research will contribute to fundamental knowledge about how young adults with asthma perceive their personal health risks to wildfire smoke, minimize their risk, and improve their health. The investigators will compare young adults who use 'Smoke Sense,' an EPA-developed smart phone application (app), with young adults who use the app plus engage in preventive activities, with young adults who do not use the app. Study aims are to: 1. Establish the feasibility (recruitment, enrollment, retention rates), acceptability (intervention engagement, fidelity, usability, attitude) and barriers and facilitators of adopting the technology of the Smoke Sense interventions and use of portable devices in young adults with asthma; 2. Explore the preliminary impact of the Smoke Sense interventions on lung function and asthma control. These primary outcomes will be assessed using objective measures (spirometry) and validated, self-report tools. Secondary outcomes will be anxiety, exposure reduction behaviors (e.g. stayed indoors, wore a mask), and symptom mitigating behaviors (use of medication, unscheduled health care appointments), measured via self-report and a Global Positioning System device. Outcome by group will be summarized. Preliminary evidence of treatment effect and its variance will be examined for a future clinical trial; 3. Explore potential mediators (medication adherence, self-management skills, stress) and moderators (asthma severity/control) of the interventions to asthma outcomes. The long-term goal is to minimize asthma exacerbations from exposure to wildfire smoke. The long-term goal of the study is to minimize asthma exacerbations from exposure to wildfire smoke.

Detailed description

Exposure to unprecedented levels of wildfire smoke is increasing cardiopulmonary mortality and is especially catastrophic in people with asthma. Little evidence exists on the effectiveness of air quality (AQ) alerts on objective measures of risk reduction behavior and health outcomes. Evidence shows that young adults are less likely to adhere to AQ alerts than older adults, yet young adulthood is a time when habits are formed in chronic illness management. The Environmental Protection Agency's (EPA) Smoke Sense smart phone application (app) is an innovative risk reduction intervention based on the health belief model and theory of planned behavior. The app invites users to record their smoke observations and health symptoms, play educational trivia games, earn badges, and explore what other users are reporting. Smoke Sense connects AQ exposure data with users' symptoms, thus framing risk reduction messages as personally relevant. Although Smoke Sense has almost 25,000 users, its impact on health outcomes has not been tested. Preliminary data suggests that users' engagement in health protective behaviors was driven in response to symptoms rather than as preventive courses of action. In a high-risk asthma population, prevention is paramount. Smoke Sense Plus is an intervention that builds on the Smoke Sense app, with value-added activities, such as notifying participants to review their asthma action plan, monitoring lung function weekly via mobile spirometry and subscribing to a social network to share strategies to minimize exposure. The purpose of this study is to assess the feasibility of the Smoke Sense interventions among young adults with asthma and pilot test the interventions compared to a control group. Sixty young adults aged 18-26 with asthma will be recruited through local universities. They will be randomized to 1 of 3 groups for a 2-month study period during wildfire season. Study aims are to: 1. Establish the feasibility (recruitment, enrollment, retention rates), acceptability (intervention engagement, fidelity, usability, attitude) and barriers and facilitators of adopting the technology of the Smoke Sense interventions and use of portable devices in young adults with asthma;51 2. Explore the preliminary impact of the Smoke Sense interventions on lung function,20 and asthma control, These primary outcomes will be assessed using objective measures (spirometry) and validated, self-report tools. Secondary outcomes will be anxiety,23 exposure reduction behaviors (e.g. stayed indoors, wore a mask),24 and symptom mitigating behaviors (use of medication, unscheduled health care appointments), measured via self-report and a Global Positioning System device. Outcome by group will be summarized. Preliminary evidence of treatment effect and its variance will be examined for a future clinical trial; 3. Explore potential mediators (medication adherence, self-management skills, stress) and moderators (asthma severity/control) of the interventions to asthma outcomes. The long-term goal is to minimize asthma exacerbations from exposure to wildfire smoke. The long-term goal of the study is to minimize asthma exacerbations from exposure to wildfire smoke.

Interventions

BEHAVIORALSmoke 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.

BEHAVIORALSmoke 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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Washington State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

Participants will be randomized with equal probability to 1 of 3 study groups in blocks of 2, 4 and 5. Random assignment of the participants will be determined using a randomization software. Random group assignment and a corresponding unique study identification (ID) number will be placed in sealed envelopes that are numbered sequentially. After the consent is signed, research personnel will open the envelope to reveal the participant's group assignment. Research personnel will record the participant's name, study ID and group assignment in a password-protected spreadsheet stored on a secure server at WSU. As part of (virtual) study visit 1, intervention participants will download the app to their smartphones. A set-up macro will ask the participant to enter their study ID which can be associated with all data captured by the app.

Eligibility

Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
No

Inclusion criteria

* 18-26 years old * Diagnosed with asthma by a health care provider * Own a smart phone (Android or iOS platforms) * Speak and read English

Exclusion criteria

* Already use the Smoke Sense app * Had surgery within 3 weeks of the study start date * Have a cardio-vascular condition * Smoke * Have or have had COVID 19 (that you're aware of)

Design outcomes

Primary

MeasureTime frameDescription
Lung Function, Specifically % Predicted Mean FEV18 weeksLung 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.
Asthma Control Test8 weeksThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app.
22
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.
22
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.
23
Total67

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up111

Baseline characteristics

CharacteristicControlTotalSmoke Sense PlusSmoke Sense
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
22 Participants67 Participants23 Participants22 Participants
Age, Continuous21.9 years
STANDARD_DEVIATION 2.5
21.9 years
STANDARD_DEVIATION 2.42
21.9 years
STANDARD_DEVIATION 2.05
21.8 years
STANDARD_DEVIATION 2.81
asthma control test20.3 units on a scale
STANDARD_DEVIATION 3.4
20.4 units on a scale
STANDARD_DEVIATION 2.5
20.3 units on a scale
STANDARD_DEVIATION 2.2
20.7 units on a scale
STANDARD_DEVIATION 1.8
mean percent predicted FEV189.8 percent
STANDARD_DEVIATION 20.1
93.1 percent
STANDARD_DEVIATION 17.8
93.4 percent
STANDARD_DEVIATION 18.6
96.2 percent
STANDARD_DEVIATION 14.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants3 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
3 Participants8 Participants2 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants1 Participants1 Participants
Race (NIH/OMB)
White
17 Participants52 Participants18 Participants17 Participants
Region of Enrollment
United States
22 participants67 participants23 participants22 participants
Sex: Female, Male
Female
18 Participants51 Participants17 Participants16 Participants
Sex: Female, Male
Male
4 Participants16 Participants6 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 220 / 23
other
Total, other adverse events
0 / 220 / 220 / 23
serious
Total, serious adverse events
0 / 220 / 220 / 23

Outcome results

Primary

Asthma Control Test

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.

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
ControlAsthma Control Test22.4 score on a scaleStandard Deviation 1.9
Smoke SenseAsthma Control Test21 score on a scaleStandard Deviation 4
Smoke Sense PlusAsthma Control Test21.5 score on a scaleStandard Deviation 2.3
p-value: 0.032t-test, 1 sided
p-value: >0.05t-test, 1 sided
p-value: 0.0008t-test, 1 sided
Primary

Lung Function, Specifically % Predicted Mean FEV1

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.

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
ControlLung Function, Specifically % Predicted Mean FEV192.9 percentage of predictedStandard Deviation 16
Smoke SenseLung Function, Specifically % Predicted Mean FEV195.6 percentage of predictedStandard Deviation 17.2
Smoke Sense PlusLung Function, Specifically % Predicted Mean FEV188.6 percentage of predictedStandard Deviation 17.2
p-value: >0.05t-test, 1 sided
p-value: >0.05t-test, 1 sided
p-value: 0.0172t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026