Clinical trial NCT05445583: Asthma and Technology in Emerging African American Adults
Official title: Asthma and Technology in Emerging African American Adults (The ATHENA Project).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: African American
Young Adult
eHealth
Mobile Health
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-07-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: Change from baseline at 3, 6, and 12 months
Secondary outcomes:
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Change from baseline at 3, 6, and 12 months
measure: Asthma exacerbations
timeFrame: Change from baseline at 3, 6, and 12 months
measure: Medication Adherence Report Scale for Asthma (MARS-A)
timeFrame: Change from baseline at 3, 6, and 12 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Change from baseline at 3, 6, and 12 months
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alan Baptist, MD.
role: PRINCIPAL_INVESTIGATOR
References: