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Mobile Health Intervention for Asthma (ATHENA Trial)

N/A
Recruiting
Led By Alan Baptist, MD.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
African American, 18-30 years of age, uncontrolled asthma (defined by a score of less than 19 on the ACT)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 3, 6, and 12 months
Awards & highlights

ATHENA Trial Summary

This trial is testing a mobile health intervention to help African American young adults with 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.

Who is the study for?
This trial is for African American young adults aged 18-30 with uncontrolled asthma, as indicated by an ACT score under 19. Participants must have a cell phone and a primary care physician. It's not for those with developmental delays, significant heart/lung disease other than asthma, current pregnancy, or heavy smoking history.Check my eligibility
What is being tested?
The ATHENA Project tests a mobile health program to manage asthma in African American young adults. It includes web-based education, video meetings with nurses, text messaging support, and physical activity tracking. Participants are randomly assigned to one or more of these components.See study design
What are the potential side effects?
Since the interventions involve non-medical technology use and lifestyle advice rather than drugs or medical procedures, there are no direct side effects like you'd expect from medication; however participants may experience discomfort or inconvenience.

ATHENA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am African American, aged 18-30, with uncontrolled asthma.

ATHENA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma Control Test (ACT)
Secondary outcome measures
Asthma Quality of Life Questionnaire (AQLQ)
Asthma exacerbations
International Physical Activity Questionnaire (IPAQ)
+1 more

ATHENA Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Text Messaging (SMS) and PATExperimental Treatment2 Interventions
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.
Group II: Supportive Accountability (SA) and PATExperimental Treatment2 Interventions
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.
Group III: SA_SMS_PATExperimental Treatment3 Interventions
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.
Group IV: Motivational Enhancement System (MES) and Physical Activity Tracking (PAT)Experimental Treatment2 Interventions
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.
Group V: MES_SMS_PATExperimental Treatment3 Interventions
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.
Group VI: Usual Care_PATActive Control1 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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,958 Total Patients Enrolled
17 Trials studying Asthma
5,073 Patients Enrolled for Asthma
Wayne State UniversityLead Sponsor
309 Previous Clinical Trials
109,095 Total Patients Enrolled
4 Trials studying Asthma
391 Patients Enrolled for Asthma
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,381 Total Patients Enrolled
17 Trials studying Asthma
2,627 Patients Enrolled for Asthma

Media Library

Physical Activity Tracking (PAT) Clinical Trial Eligibility Overview. Trial Name: NCT05445583 — N/A
Asthma Research Study Groups: Supportive Accountability (SA) and PAT, SA_SMS_PAT, Text Messaging (SMS) and PAT, Motivational Enhancement System (MES) and Physical Activity Tracking (PAT), Usual Care_PAT, MES_SMS_PAT
Asthma Clinical Trial 2023: Physical Activity Tracking (PAT) Highlights & Side Effects. Trial Name: NCT05445583 — N/A
Physical Activity Tracking (PAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445583 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility criteria to participate in this medical experiment?

"This asthma trial is currently looking for 180 individuals, aged 18 to 30, that identify as African American and have a score of less than 19 on the Asthma Control Test (ACT). Furthermore, in order to be considered eligible participants must possess a mobile phone throughout their involvement with this study and maintain contact with an assigned primary care physician."

Answered by AI

Do individuals under the age of 85 meet the criteria for participation in this research?

"This medical trial is available to adults aged between 18-30 years old. In contrast, there are 116 research studies for individuals below the age of majority and 198 trials accessible to senior citizens."

Answered by AI

Does this experiment require additional volunteers to participate?

"Per the clinicaltrials.gov website, this medical trial is not presently recruiting participants; however, it was initially posted on August 1st 2022 and last modified on June 29th 2022. Despite that fact, there are currently 322 other trials enrolling patients right now."

Answered by AI

Who else is applying?

What state do they live in?
New York
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan
Wayne State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Asthma and Technology in Emerging African American Adults
Alan Baptist 2023. "Asthma and Technology in Emerging African American Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445583.
All > Pediatric Asthma > Asthma
~90 spots leftby Feb 2025
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