Asthma and Technology in Emerging African American Adults
NCT ID: NCT05445583
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-08-01
2026-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
30 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Michigan
OTHER
Responsible Party
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Alan Baptist
Principal Investigator
Principal Investigators
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Alan Baptist, MD.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Florida State University
Tallahassee, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Karen MacDonell, Ph.D
Role: primary
Alan Baptist, MD
Role: primary
April Carcone
Role: primary