Mobile Health Intervention for Asthma
(ATHENA Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Cardiopulmonary disease, Smoking, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Motivational Enhancement System (MES) and related interventions for asthma management?
Research shows that text message reminders can improve medication adherence in asthma patients, and mobile technology interventions can help manage asthma by allowing individuals to monitor medication use and symptoms. A study found that personalized text messages improved asthma control and quality of life, although the improvements were modest and not sustained.
12345Is the Mobile Health Intervention for Asthma safe for humans?
The studies reviewed indicate that text messaging interventions for asthma management are generally well-received and considered acceptable by participants, suggesting they are safe for human use.
12467How does the mobile health intervention for asthma differ from other treatments?
The mobile health intervention for asthma is unique because it uses mobile technology, like apps and text messages, to help people manage their asthma by reminding them to take their medication, track symptoms, and follow action plans. This approach is different from traditional treatments as it focuses on improving medication adherence and self-management through digital tools.
13689Eligibility Criteria
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.
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
+1 more
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.
+1 more
Trial Timeline
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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Florida State UniversityTallahassee, FL
Wayne State UniversityDetroit, MI
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
Wayne State UniversityLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
A Systematic Review of the Effectiveness of Text Message Reminders on Asthma Medication Adherence. [2022]Cell phone text messaging reminders offers the promise of an efficient technology for the management of chronic diseases, such as asthma. This review aims to evaluate the effectiveness of text message reminders in improving medication adherence for asthma compared to usual care.
A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. [2017]We enrolled 64 patients age 12 to 22 years with a diagnosis of poorly controlled persistent asthma in a 6-month longitudinal crossover study. During the 3 intervention months, participants created personalized text messages to be sent to their phones. Adherence was objectively monitored in 22 of the participants. The adolescent participants gave high ratings on the acceptability of the text messaging system. Asthma control improved from baseline to month 1 regardless of whether teens were in the texting or control group. While participants were in the texting group, their quality of life improved and worry about their asthma decreased. Receiving the text intervention resulted in an increase in adherence of 2.75% each month relative to no intervention, but the improvements were not sustained. There was modest improvement in asthma control and quality of life outcomes, as well as improved adherence during the texting intervention.
Mobile Technology Interventions for Asthma Self-Management: Systematic Review and Meta-Analysis. [2019]Mobile technology interventions (MTI) are becoming increasingly popular in the management of chronic health behaviors. Most MTI allow individuals to monitor medication use, record symptoms, or store and activate disease-management action plans. Therefore, MTI may have the potential to improve low adherence to medication and action plans for individuals with asthma, which is associated with poor clinical outcomes.
The feasibility of text reminders to improve medication adherence in adolescents with asthma. [2022]Personal health applications have the potential to help patients with chronic disease by improving medication adherence, self-efficacy, and quality of life. The goal of this study was to assess the impact of MyMediHealth (MMH) - a website and a short messaging service (SMS)-based reminder system - on medication adherence and perceived self-efficacy in adolescents with asthma.
Systematic Review of mHealth Applications That Interface with Inhaler Sensors in Asthma. [2021]A better understanding of outcomes associated with mobile health (mHealth) applications (apps) for asthma self-management that pair with inhaler sensor technology is needed for clinicians to practice evidence-based medicine.
Patient Perspectives on a Text Messaging Program to Support Asthma Management: A Qualitative Study. [2022]Introduction. This study investigated participants' acceptance of a short messaging service (SMS) intervention designed to support asthma management, including suggestions regarding program delivery and message content. Methods. Individual and group interviews were conducted with patients from a safety-net health care system in Denver, Colorado. Eligible participants were English or Spanish speakers between the ages of 13 and 40 years, with diagnosed persistent asthma. All individual and group interviews were digitally recorded, transcribed, translated from Spanish to English (where applicable), and analyzed for thematic content by experienced analysts using established qualitative content techniques. The qualitative software package ATLAS.ti was used for data analysis and management. Results. This study included a total of 43 participants. In general, participants were receptive toward the SMS program and supported the use of tailored and interactive messages. Adolescents supported the idea of enhancing care by sending messages to a support person, such as a parent or guardian. However, adults were less receptive toward this idea. Participants also preferred directive educational messages and cues to action, while general messages reminding them of their asthma diagnosis were viewed less favorably. Implications. The results from this study will inform a randomized control trial evaluating the efficacy of the SMS intervention.
Pedometers, the frustrating motivators: a qualitative investigation of users' experiences of the Yamax SW-200 among people with multiple sclerosis. [2022]Self-monitoring may represent a mechanism to enhance physical activity among people with multiple sclerosis. To optimise activity monitoring as a behavioural tool to increase physical activity, user experience must be understood. This study evaluated user experience of the Yamax SW-200 Digi-walker pedometer in a group of people with MS.
A Systematic Evaluation of Asthma Management Apps Examining Behavior Change Techniques. [2020]Mobile health (mHealth) apps have the potential to facilitate asthma self-management by including medication reminders, allowing self-monitoring of symptoms, improving access and quality of information communicated with provider, and providing educational resources to patients and parents. Many apps exist for asthma management; however, the extent to which apps include evidence-based behavior change strategies has not been examined.
Apps for asthma self-management: a systematic assessment of content and tools. [2023]Apps have been enthusiastically adopted by the general public. They are increasingly recognized by policy-makers as a potential medium for supporting self-management of long-term conditions. We assessed the degree to which current smartphone and tablet apps for people with asthma offer content and tools of appropriate quality to support asthma self-management.