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

NCT04724733 | Completed Results DMC

• 2 other identifiers: 180351R21NR019071-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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

Interventions

Smoke Sense BEHAVIORAL

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

Smoke Sense Plus BEHAVIORAL

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.

Smoke Sense Plus

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington State University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Washington State University College of Nursing

Spokane, Washington, 99202, United States

Location

Related Publications (1)

• 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.

  PMID: 34636066 DERIVED

MeSH Terms

Conditions

Asthma; Pemphigus and fogo selvagem; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Limitations and Caveats

37 participants recorded both ACT and FEV1 measures that were within the study visit window (3 days from scheduled) and within 1 day of each other at both baseline and week 8. This limited our ability to assess changes in clinical outcomes and will be addressed in future work.

Results Point of Contact

• Title: Julie Postma, Professor, Associate Dean for Research
• Organization: Washington State University College of Nursing

jpostma@wsu.edu

509-324-7287

Study Officials

• Julie M Postma, PhD

  Washington State University College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: January 26, 2021
• Study Start: August 6, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 14, 2020
• Last Updated: April 28, 2023
• Results First Posted: August 2, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)