Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT05445583

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Motivational Enhancement System (MES)

Supportive Accountability (SA)

Text Messaging (SMS)

Physical Activity Tracking (PAT)

Study Details

Brief summary:

The purpose of the ATHENA Project is to test a mobile health intervention to help African American young adults better manage their asthma. The program has four components: 1) a web-based, mobile asthma program delivered to participants' mobile device, 2) meetings with an asthma nurse via video conference, 3) text messaging, and 4) physical activity tracking. Participants will be randomly assigned to one or more of these components to better meet the needs of young adults with asthma.

Conditions

Asthma

Study ID

NCT05445583

Start date

Aug 1, 2023

Status verified date

May, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • African American, 18-30 years of age, uncontrolled asthma (defined by a score of less than 19 on the ACT), own or have access to a cell phone for the duration of the study, have a primary care physician (PCP)

Exclusion Criteria:

  • Significant cardiopulmonary disease (including chronic obstructive pulmonary disease), a greater than 20 pack per year smoking history, developmental delay or mental illness such that participation in the program would not be possible, pregnancy

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Motivational Enhancement System (MES) and Physical Activity Tracking (PAT)

MES is a web-based, mobile asthma management intervention delivered to participants' personal mobile devices. There are 4 sessions, completed over 10 weeks, with each session taking approximately 15-20 minutes. During Session 1, participants will identify asthma-related problems they may encounter and will receive asthma information and motivation. Between Session 1 and Session 2, participants will be asked to complete an electronic daily diary for 7 days. Session 2 allows participants to select up to 2 goals to address. Session 3 occurs over the course of 4 weeks and provides tailored messages based on problem and goal selection. The final session (Session 4), asks participants for feedback on how well they feel they accomplished their goal. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

experimental: Supportive Accountability (SA) and PAT

SA is an asthma management intervention delivered by asthma nurses trained in targeted MI skills (e.g., open-ended questions around change talk, affirmations) via participants' personal mobile devices (e.g., Skype, FaceTime, voice calls, and SMS). Sessions with the nurse will be approximately 15-20 minutes in length and will focus on ways to improve asthma care. There are 4 sessions with the nurse, over the course of 10 weeks. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

experimental: Text Messaging (SMS) and PAT

SMS will target asthma knowledge. One-way SMS messages will be sent to participants' personal mobile devices with facts about asthma management, links to educational web content, and videos providing information about living with asthma. Text messages will be sent twice a week for the first 5 weeks and once a week for the last 5 weeks. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

experimental: MES SMS PAT

Participants will receive a combination of the MES and SMS interventions. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

experimental: SA SMS PAT

Participants will receive a combination of the SA and SMS interventions. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

no intervention: Usual Care PAT

Participants will continue to receive standard clinical asthma care. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

Interventions

Motivational Enhancement System (MES)

MES is an eHealth application and focuses on asthma management behaviors with feedback on asthma symptoms, physical activity, adherence, and tailored education. The program is interactive and tailored to each participant by (1) allowing participants to choose barriers/goals related to their asthma care and (2) by sending personalized feedback based on participant daily diary responses. MES consists of 4 sessions delivered over the course of 10 weeks within 10 smaller 5-10 minute blocks.

Supportive Accountability (SA)

Supportive accountability (SA) is an asthma management intervention delivered by asthma nurses trained in motivational interviewing skills (e.g., open-ended questions around change talk, affirmations) via participants' personal mobile devices (e.g., Skype, FaceTime, voice calls, and SMS). The theory underlying SA is that education and behavior change are most impactful when delivered by a knowledgeable yet supportive authority figure (i.e. nurse).

Text Messaging (SMS)

SMS will target asthma knowledge. SMS messages will be sent via CIAS 3.0 to participants' personal mobile devices with facts about asthma management, links to educational web content, and videos providing information about living with asthma. Information covered includes 'What is asthma,' 'What is an asthma attack,' 'What causes an asthma attack,' 'How is asthma treated,' 'Asthma and weather,' 'Using an inhaler,' 'Using a spacer,' and 'Asthma Action Plans.'

Physical Activity Tracking (PAT)

All participants will be provided a wearable physical activity tracking device, which will allow them to accurately track exercise and total steps each day. Through PAT, users will be able to set daily goals and attain motivation to continue asthma management. For individuals randomized to groups that also include MES or SA, those programs will incorporate PAT data that is remotely transmitted, to facilitate asthma management motivation.

Primary outcome measure

  • Asthma Control Test (ACT) [ Time Frame: Change from baseline at 3, 6, and 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48106

Principal Investigator:

Alan Baptist, MD

More Information

Sponsor

University of Michigan

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • African American
  • Young Adult
  • eHealth
  • Mobile Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-26.