AsthmaATHENANCT05445583
Asthma and Technology in Emerging African American Adults
A study testing Motivational Enhancement System (MES), Supportive Accountability (SA) and Text Messaging (SMS) in people with Asthma, run by University of Michigan at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Asthma
- What is being tested?
- Motivational Enhancement System (MES), Supportive Accountability (SA) and Text Messaging (SMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48106
Alan Baptist, MD
Alan Baptist, MD
- Not yet recruiting
Wayne State University
Detroit, Michigan, 48202
April Carcone, acarcone@med.wayne.edu
- Not yet recruiting
Florida State University
Tallahassee, Florida, 32306
Karen MacDonell, Ph.D, karen.macdonell@med.fsu.edu
About this study
Official title: Asthma and Technology in Emerging African American Adults (The ATHENA Project).
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.
Read the detailed description
Asthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEA; ages 18-30), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be most effective. However, face-to-face interventions are often difficult to implement, especially among emerging adults. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, the research team will use an innovative strategy to develop a mobile asthma management intervention using the most effective combination of a smart phone app delivering personalized asthma information (MES), nurse-delivered asthma education (SA), text messaging (SMS), and physical activity tracking (PAT).
The purpose of this proposal is to develop an effective mHealth intervention to improve asthma management and asthma control in AAEA. Investigators will assess the ability of multiple technologic components to assist and improve traditional asthma education. Upon completion of the study, investigators will have an empirically-supported mobile asthma management intervention to improve asthma control for AAEA.
It is hypothesized that post-intervention, participants with uncontrolled asthma will show clinically-significant improvement in asthma control and improvements in asthma management behaviors, quality of life, symptoms, adherence, and exacerbations will also be observed.
- Conditions
- Asthma
- Being tested
- Motivational Enhancement System (MES), Supportive Accountability (SA), Text Messaging (SMS), Physical Activity Tracking (PAT)
- Keywords
- African American, Young Adult, eHealth, Mobile Health
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement System (MES)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Enhancement System (MES) and Physical Activity Tracking (PAT) | Experimental | 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. Receives: Behavioral: Motivational Enhancement System (MES); Behavioral: Physical Activity Tracking (PAT) |
| Supportive Accountability (SA) and PAT | Experimental | 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. Receives: Behavioral: Supportive Accountability (SA); Behavioral: Physical Activity Tracking (PAT) |
| Text Messaging (SMS) and PAT | Experimental | 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. Receives: Behavioral: Motivational Enhancement System (MES); Behavioral: Physical Activity Tracking (PAT) |
| MES_SMS_PAT | Experimental | 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. Receives: Behavioral: Motivational Enhancement System (MES); Behavioral: Text Messaging (SMS); Behavioral: Physical Activity Tracking (PAT) |
| SA_SMS_PAT | Experimental | 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. Receives: Behavioral: Motivational Enhancement System (MES); Behavioral: Text Messaging (SMS); Behavioral: Physical Activity Tracking (PAT) |
| Usual Care_PAT | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT)
Frequency of asthma symptoms based on self-report
Measured: Change from baseline at 3, 6, and 12 months
Secondary outcomes (4)
Asthma Quality of Life Questionnaire (AQLQ)
Measures functional impairments that are most troublesome to adults with asthma
Measured: Change from baseline at 3, 6, and 12 months
Asthma exacerbations
Reduction in number of asthma exacerbations
Measured: Change from baseline at 3, 6, and 12 months
Medication Adherence Report Scale for Asthma (MARS-A)
Self reported adherence to asthma controller medication
Measured: Change from baseline at 3, 6, and 12 months
International Physical Activity Questionnaire (IPAQ)
Assess kinds of physical activities and time spent being physically active
Measured: Change from baseline at 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Alan Baptist, University of Michigan
- Investigators
- Alan Baptist, MD., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445583
- Sponsor's protocol ID
- R01NR019566
- Other IDs
- 1R01NR019566-01A1
- Acronym
- ATHENA
- Status last verified
- May 2026
- First submitted
- 14 Apr 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma and Technology in Emerging African American Adults (The ATHENA Project).
- ClinicalTrials.gov ID
- NCT05445583
- Acronym / sponsor ID
- ATHENA / R01NR019566
- Conditions
- Asthma
- Keywords
- African American, Young Adult, eHealth, Mobile Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEA; ages 18-30), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be most effective. However, face-to-face interventions are often difficult to implement, especially among emerging adults. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, the research team will use an innovative strategy to develop a mobile asthma management intervention using the most effective combination of a smart phone app delivering personalized asthma information (MES), nurse-delivered asthma education (SA), text messaging (SMS), and physical activity tracking (PAT).
The purpose of this proposal is to develop an effective mHealth intervention to improve asthma management and asthma control in AAEA. Investigators will assess the ability of multiple technologic components to assist and improve traditional asthma education. Upon completion of the study, investigators will have an empirically-supported mobile asthma management intervention to improve asthma control for AAEA.
It is hypothesized that post-intervention, participants with uncontrolled asthma will show clinically-significant improvement in asthma control and improvements in asthma management behaviors, quality of life, symptoms, adherence, and exacerbations will also be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Motivational Enhancement System (MES) and Physical Activity Tracking (PAT) | Experimental | Behavioral: Motivational Enhancement System (MES), Behavioral: 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. |
| Supportive Accountability (SA) and PAT | Experimental | Behavioral: Supportive Accountability (SA), Behavioral: Physical Activity Tracking (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. |
| Text Messaging (SMS) and PAT | Experimental | Behavioral: Motivational Enhancement System (MES), Behavioral: Physical Activity Tracking (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. |
| MES_SMS_PAT | Experimental | Behavioral: Motivational Enhancement System (MES), Behavioral: Text Messaging (SMS), Behavioral: Physical Activity Tracking (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. |
| SA_SMS_PAT | Experimental | Behavioral: Motivational Enhancement System (MES), Behavioral: Text Messaging (SMS), Behavioral: Physical Activity Tracking (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. |
| Usual Care_PAT | No intervention | –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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | MES_SMS_PAT, Motivational Enhancement System (MES) and Physical Activity Tracking (PAT), SA_SMS_PAT, Text Messaging (SMS) and PAT |
| 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). | Behavioural | Supportive Accountability (SA) and PAT |
| 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.' | Behavioural | MES_SMS_PAT, SA_SMS_PAT |
| 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. | Behavioural | MES_SMS_PAT, Motivational Enhancement System (MES) and Physical Activity Tracking (PAT), SA_SMS_PAT, Supportive Accountability (SA) and PAT, Text Messaging (SMS) and PAT |
Primary outcome
Asthma Control Test (ACT)
Time frame: Change from baseline at 3, 6, and 12 months
Frequency of asthma symptoms based on self-report
4 secondary outcomes
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Change from baseline at 3, 6, and 12 months
Asthma exacerbations
Time frame: Change from baseline at 3, 6, and 12 months
Medication Adherence Report Scale for Asthma (MARS-A)
Time frame: Change from baseline at 3, 6, and 12 months
International Physical Activity Questionnaire (IPAQ)
Time frame: Change from baseline at 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- 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.
Alan Baptist, MD. principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement System (MES), Supportive Accountability (SA) and Text Messaging (SMS) in people with Asthma, run by University of Michigan at 3 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan Baptist, MD. (734-936-5634, abaptist@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) (time frame: Change from baseline at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.