NCT05445583

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
0mo left

Started Aug 2023

Typical duration for not_applicable asthma

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2023May 2026

First Submitted

Initial submission to the registry

April 14, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

April 14, 2022

Last Update Submit

March 10, 2026

Conditions

Keywords

African AmericanYoung AdulteHealthMobile Health

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Test (ACT)

    Frequency of asthma symptoms based on self-report

    Change from baseline at 3, 6, and 12 months

Secondary Outcomes (4)

  • Asthma Quality of Life Questionnaire (AQLQ)

    Change from baseline at 3, 6, and 12 months

  • Asthma exacerbations

    Change from baseline at 3, 6, and 12 months

  • Medication Adherence Report Scale for Asthma (MARS-A)

    Change from baseline at 3, 6, and 12 months

  • International Physical Activity Questionnaire (IPAQ)

    Change from baseline at 3, 6, and 12 months

Study Arms (6)

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.

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.

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.

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.

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.

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.

Interventions

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_PATMotivational Enhancement System (MES) and Physical Activity Tracking (PAT)SA_SMS_PATSupportive Accountability (SA) and PATText Messaging (SMS) and PAT

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.

MES_SMS_PATMotivational Enhancement System (MES) and Physical Activity Tracking (PAT)SA_SMS_PATText Messaging (SMS) and PAT

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).

Supportive Accountability (SA) and PAT

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.'

MES_SMS_PATSA_SMS_PAT

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Florida State University

Tallahassee, Florida, 32306, United States

NOT YET RECRUITING

University of Michigan

Ann Arbor, Michigan, 48106, United States

RECRUITING

Wayne State University

Detroit, Michigan, 48202, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Alan Baptist, MD.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Baptist, MD.

CONTACT

Muzhda Hashmi, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

July 6, 2022

Study Start

August 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations