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

Asthma Clinical Trial

— TRAK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724733
• Other study ID #: 18035
• Secondary ID: 1R21NR019071-01
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: December 14, 2020

Study information

• Verified date: April 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 14, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
United States	Washington State University College of Nursing	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks
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.	8 weeks