AsthmaTRAKNCT04724733
Promoting Risk Reduction Among Young Adults With Asthma During Wildfire Smoke Events (TRAK)
A study testing Smoke Sense and Smoke Sense Plus in people with Asthma, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Asthma
- What is being tested?
- Smoke Sense and Smoke Sense Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-26 years old
- Diagnosed with asthma by a health care provider
- Own a smart phone (Android or iOS platforms)
- Speak and read English
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University College of Nursing
Spokane, Washington, 99202
About this study
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:
- 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;
- 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;
- 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.
Read the 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:
- 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
- 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;
- 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.
- Conditions
- Asthma
- Being tested
- Smoke Sense, Smoke Sense Plus
- Keywords
- Young adult, quality of life, wildfires, risk reduction behavior, smartphone
- Medical subject headings
- Asthma, Pemphigus and fogo selvagem, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke SenseBehavioural
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 PlusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app. |
| Smoke Sense | Experimental | Not described Receives: Behavioral: Smoke Sense |
| Smoke Sense Plus | Active comparator | Not described Receives: Behavioral: Smoke Sense Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start6 Aug 2020
- Primary completion11 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Julie Postma, Washington State University
- Investigators
- Julie M Postma, PhD, Principal investigator, Washington State University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724733
- Sponsor's protocol ID
- 18035
- Other IDs
- 1R21NR019071-01
- Acronym
- TRAK
- Status last verified
- Apr 2023
- First submitted
- 19 Jun 2020
- Last updated
- 28 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Postma JM, Odom-Maryon T, Rappold AG, Haverkamp H, Amiri S, Bindler R, Whicker J, Walden V. Promoting risk reduction among young adults with asthma during wildfire smoke: A feasibility study. Public Health Nurs. 2022 Mar;39(2):405-414. doi: 10.1111/phn.12986. Epub 2021 Oct 11.
PubMed 34636066
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Risk Reduction Among Young Adults With Asthma During Wildfire Smoke Events (TRAK)
- ClinicalTrials.gov ID
- NCT04724733
- Acronym / sponsor ID
- TRAK / 18035
- Conditions
- Asthma
- Keywords
- Young adult, quality of life, wildfires, risk reduction behavior, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Posted 2 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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:
- 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
- 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;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive incentives for study participation but will not be introduced to the Smoke Sense app. |
| Smoke Sense | Experimental | Behavioral: Smoke Sense |
| Smoke Sense Plus | Active comparator | Behavioral: Smoke Sense Plus |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-26 years old
- Diagnosed with asthma by a health care provider
- Own a smart phone (Android or iOS platforms)
- Speak and read English
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoke SenseSmoke 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. | Behavioural | Smoke Sense |
| Smoke Sense PlusParticipants 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. | Behavioural | Smoke Sense Plus |
Primary outcome
Lung Function, Specifically % Predicted Mean FEV1
Time frame: 8 weeks
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.
Asthma Control Test
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34636066Postma JM, Odom-Maryon T, Rappold AG, Haverkamp H, Amiri S, Bindler R, Whicker J, Walden V. Promoting risk reduction among young adults with asthma during wildfire smoke: A feasibility study. Public Health Nurs. 2022 Mar;39(2):405-414. doi: 10.1111/phn.12986. Epub 2021 Oct 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie M Postma, PhD principal investigator
Washington State University College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoke Sense and Smoke Sense Plus in people with Asthma, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Function, Specifically % Predicted Mean FEV1 (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.