Mobile Health Intervention for Asthma

(ATHENA Trial)

Recruiting at 2 trial locations

Overseen By Muzhda Hashmi, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cardiopulmonary disease, Smoking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a mobile health program designed to help young African American adults manage asthma more effectively. It includes web-based sessions, video meetings with an asthma nurse, text messages (SMS), and physical activity tracking (PAT). Participants may be assigned to one or more components to determine which combination works best. This trial suits African American young adults with uncontrolled asthma who have access to a cellphone. As an unphased trial, participants can contribute to innovative research that could enhance asthma management within their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile health intervention is safe for managing asthma?

Research shows that the treatments tested in this trial have been well-tolerated in past studies. For the Motivational Enhancement System (MES), research has found that similar digital health tools can help manage asthma without causing significant side effects, suggesting they are generally safe for users.

The Supportive Accountability (SA) approach, which involves working with asthma nurses, has been linked to better self-management and fewer hospital visits, with no major safety concerns reported.

Text Messaging (SMS) interventions for asthma have been studied and found to help people adhere to their treatment and feel more confident in managing their asthma. These studies did not report any serious side effects, indicating SMS interventions are safe to use.

Overall, each treatment aims to improve asthma care through mobile health technology and has been found safe in human studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative mobile health interventions for asthma management, potentially offering more personalized and accessible care. Unlike traditional treatments that focus mainly on medication, these methods incorporate motivational enhancement, supportive accountability, and educational text messaging, all delivered through mobile devices. These interventions aim to empower individuals to actively manage their asthma by setting personal goals, receiving tailored advice, and tracking physical activity, which could lead to improved health outcomes and patient engagement. By integrating technology with asthma care, this trial could pave the way for more effective and patient-centered asthma management strategies.

What evidence suggests that this trial's treatments could be effective for asthma?

Research shows that mobile health tools can greatly aid in managing asthma. In this trial, participants may receive the Motivational Enhancement System (MES), which studies have found helps people better control their asthma by simplifying adherence to medication plans. Another group will receive Supportive Accountability (SA), involving nurse-led motivational support, which has effectively helped patients manage asthma and reduce hospital visits. Additionally, some participants will receive Text Messaging (SMS) interventions, known to increase asthma knowledge and improve self-management. Overall, these methods focus on empowering individuals to manage their asthma and have shown promising results in improving asthma control. ^{6 7 8 9 10}

Who Is on the Research Team?

Alan Baptist, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am African American, aged 18-30, with uncontrolled asthma, have a cell phone, and a primary care doctor.

Own or have access to a cell phone for the duration of the study

Have a primary care physician (PCP)

Exclusion Criteria

You have a developmental delay or mental illness that would make it hard for you to take part in the program.

I have a serious heart or lung condition.

You have smoked more than one pack of cigarettes a day for 20 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mobile health intervention including web-based asthma management, nurse meetings, text messaging, and physical activity tracking over 10 weeks

10 weeks

4 sessions (virtual)

Follow-up

Participants are monitored for improvements in asthma control, quality of life, and medication adherence

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Enhancement System (MES)
• Physical Activity Tracking (PAT)
• Supportive Accountability (SA)
• Text Messaging (SMS)

Trial Overview 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.

How Is the Trial Designed?

Group I: Text Messaging (SMS) and PAT Experimental Treatment 2 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 PAT Experimental Treatment 2 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_PAT Experimental Treatment 3 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 Treatment 2 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_PAT Experimental Treatment 3 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_PAT Active Control 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A systematic review identified 6 mHealth apps that integrate with inhaler sensors, showing modest improvements in maintenance inhaler adherence and reduced use of rescue inhalers among asthma patients.

Despite these positive effects, the apps did not significantly impact overall asthma control or health outcomes, indicating a need for more comprehensive studies to evaluate their effectiveness in managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of mHealth Applications That Interface with Inhaler Sensors in Asthma. Nguyen, E., Miao, B., Pugliese, N., et al.[2021]

A review of 103 asthma apps revealed that only three provided comprehensive and reliable information about asthma, and none combined this with effective self-management tools, highlighting a significant gap in quality.

Many apps made unsupported recommendations for asthma management, and compliance with health information best practices was inconsistent, suggesting that healthcare professionals should be cautious when recommending these apps to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps for asthma self-management: a systematic assessment of content and tools. Huckvale, K., Car, M., Morrison, C., et al.[2023]

The Yamax SW-200 Digi-walker pedometer effectively raised awareness and motivation for physical activity among 15 adults with multiple sclerosis during a 12-week intervention, highlighting its potential as a self-monitoring tool.

However, concerns regarding the accuracy and usability of the pedometer were noted, suggesting that careful selection of monitoring tools is crucial for ensuring engagement and effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pedometers, the frustrating motivators: a qualitative investigation of users' experiences of the Yamax SW-200 among people with multiple sclerosis. Fortune, J., Norris, M., Stennett, A., et al.[2022]

Mobile technology interventions (MTI) have been shown to significantly improve medication adherence and clinical outcomes in individuals with asthma, with moderate to large effect sizes compared to standard treatment, based on a systematic review of 11 studies.

MTI was found to be equally effective as traditional paper-based monitoring methods, indicating that while MTI can enhance self-management in asthma, further research is needed to explore the impact of behavior change techniques and user engagement on its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Technology Interventions for Asthma Self-Management: Systematic Review and Meta-Analysis. Miller, L., Schüz, B., Walters, J., et al.[2019]

A study involving 43 participants with persistent asthma showed that most were receptive to an SMS intervention for asthma management, particularly favoring tailored and interactive messages.

Adolescents expressed interest in sending messages to a support person, while adults were less enthusiastic; participants preferred directive educational content over general reminders about their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspectives on a Text Messaging Program to Support Asthma Management: A Qualitative Study. Doyle, R., Albright, K., Hurley, LP., et al.[2022]

A systematic review of five randomized controlled trials found mixed results regarding the effectiveness of text message reminders in improving asthma medication adherence, indicating that while results vary, reminders can help address forgetfulness.

Despite limited evidence supporting widespread effectiveness, text messaging is recognized as a promising tool for enhancing medication adherence in patients with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Effectiveness of Text Message Reminders on Asthma Medication Adherence. Dong, J., Reeves, L., Ali, A., et al.[2022]

A review of 23 asthma management apps revealed that they utilized an average of 4 behavior change techniques (BCTs), with common strategies including self-monitoring and feedback, which can enhance asthma self-management.

Two apps, Kiss myAsthma and AsthmaMD, stood out for their high quality and use of at least 8 BCTs, indicating they may be more effective tools for patients managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Evaluation of Asthma Management Apps Examining Behavior Change Techniques. Ramsey, RR., Caromody, JK., Voorhees, SE., et al.[2020]

In a 6-month study with 64 adolescents aged 12 to 22 with poorly controlled asthma, personalized text messaging improved adherence to asthma management by 2.75% each month during the intervention period.

Participants reported better quality of life and reduced worry about their asthma while receiving text messages, although these improvements in asthma control were not sustained after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. Britto, MT., Rohan, JM., Dodds, CM., et al.[2017]

The MyMediHealth (MMH) system, which includes a website and SMS reminders, significantly improved medication adherence, quality of life, and self-efficacy in 89 adolescents with asthma over a 3-week period compared to a control group.

Participants reported high satisfaction with the MMH system, although usage varied, particularly being lower among African American patients, indicating a need for targeted strategies to enhance engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of text reminders to improve medication adherence in adolescents with asthma. Johnson, KB., Patterson, BL., Ho, YX., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/8SB02-NdSUelyrcP3mzc4g/project-details/10838562

Project Details - NIH RePORTER The Motivational Enhancement System (MES) for Asthma Management is a mobile 4-session intervention utilizing supported self-regulation and Motivational ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35536642/

Asthma and Technology in Emerging African American ... The purpose of this study is to develop an effective mobile asthma management intervention to improve control among AAEAs.

3. research.wayne.edu research.wayne.edu/news/wayne-state-university-secures-nih-grant-to-develop-mobile-intervention-for-young-black-adults-with-asthma-46756

Wayne State University secures NIH grant to develop ... “We hypothesize that post-intervention, participants with uncontrolled asthma will show clinically-significant improvement in asthma control,” ...

4. withpower.com withpower.com/trial/phase-asthma-7-2022-e37ee

Mobile Health Intervention for Asthma (ATHENA Trial) Mobile technology interventions (MTI) have been shown to significantly improve medication adherence and clinical outcomes in individuals with asthma, with ...

5. publications.ersnet.org publications.ersnet.org/content/erjor/11/5/01178-2024

Enhancing severe asthma care: real-world outcomes of a ... 91% of patients reported that the intervention was easy to use and 83% felt it supported regular inhaler use, leading to increased confidence in self-management ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7660344/

Managing Asthma and Obesity Related Symptoms ... The two evidence-based behavioral change strategies (Motivational Enhancement (ME) and Behavioral Activation (BA)) will be specifically geared ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357360/

Investigating Adherence to Asthma Management with an ... Abstract. Background. Adherence to prescribed inhaler use is critical for effective asthma management and to prevent exacerbations.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02761746

Motivational Enhancement System for Adherence (MESA ... This study plans to test a brief, two-session, computer-delivered motivational intervention to prevent adherence difficulties among youth newly prescribed ART.

9. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(21)00233-6/fulltext

Digital Health Technology in Asthma Digital technology provides an opportunity to improve and individualize asthma self-management significantly across a variety of intervention ...

10. tandfonline.com tandfonline.com/doi/full/10.1080/02770903.2020.1830413

Going mobile with primary care: smartphone-telemedicine ... We conclude that smartphone telemedicine could substantially improve clinical asthma management, adherence to guidelines, and patient outcomes.