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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

Must not have

Significant cardiopulmonary disease (including chronic obstructive pulmonary disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious heart or lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 3, 6, and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma Control Test (ACT)

Secondary study objectives

Asthma Quality of Life Questionnaire (AQLQ)

Asthma exacerbations

International Physical Activity Questionnaire (IPAQ)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met