Clinical trial NCT04724733: Promoting Risk Reduction Among Young Adults With Asthma During Wildfire Smoke Events (TRAK)
Official title: Promoting Risk Reduction Among Young Adults With Asthma During Wildfire Smoke Events (TRAK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Young adult
quality of life
wildfires
risk reduction behavior
smartphone
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-01-26
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Lung Function, Specifically % Predicted Mean FEV1
timeFrame: 8 weeks
measure: Asthma Control Test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University College of Nursing
state: Washington
Study officials:
affiliation: Washington State University College of Nursing
name: Julie M Postma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.