Asthma and Technology in Emerging African American Adults

Asthma Clinical Trial

— ATHENA  

Official title:

Asthma and Technology in Emerging African American Adults (The ATHENA Project).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05445583
• Other study ID #: R01NR019566
• Secondary ID: 1R01NR019566-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 2026

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: Alan Baptist, MD.
• Phone: 734-936-5634
• Email: abaptist[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test (ACT)	Frequency of asthma symptoms based on self-report	Change from baseline at 3, 6, and 12 months
Secondary	Asthma Quality of Life Questionnaire (AQLQ)	Measures functional impairments that are most troublesome to adults with asthma	Change from baseline at 3, 6, and 12 months
Secondary	Asthma exacerbations	Reduction in number of asthma exacerbations	Change from baseline at 3, 6, and 12 months
Secondary	Medication Adherence Report Scale for Asthma (MARS-A)	Self reported adherence to asthma controller medication	Change from baseline at 3, 6, and 12 months
Secondary	International Physical Activity Questionnaire (IPAQ)	Assess kinds of physical activities and time spent being physically active	Change from baseline at 3, 6, and 12 months