Telemedicine Enhanced Asthma Management for Teen Asthma

Overseen By Maria Fagnano, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Non-English/Spanish, Other studies, Moving, Heart disease, others

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

Compensation: Varies

Number of Visits: 4

360 Participants Needed

Trial Summary

What is the purpose of this trial?

Low-income, minority teenagers have disproportionately high rates of asthma morbidity, including excess risk of emergency department visits, hospitalizations, and death from asthma. Despite well established guidelines, under-treatment for asthma is common, particularly for poor urban teens. This study aims to test a novel, developmentally appropriate and scalable model of care to ensure optimal guideline-based treatment for urban teens with difficult to control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers for Teens (TEAM-UP for Teens) program includes 3 core components: 1- An individualized asthma management plan developed at the start of the school year via a real-time, synchronous school-based telemedicine visit that directly connects the teen to an asthma specialist, 2- School-based or video supported directly observed therapy (DOT) to implement the medication plan and allow for teens to experience the benefits of consistent therapy, 3- Follow-up telehealth visits with a nurse asthma educator to facilitate ongoing care and provide developmentally appropriate self-management support. This study is a randomized trial of TEAM-UP for Teens vs an enhanced care (EC) control group (n=360, 12-16 years). We will assess the effectiveness of the program in reducing morbidity and improving guideline-based asthma care. Our main hypothesis is that Teens receiving the TEAM-UP for Teens intervention will have more symptom-free days at 3, 5, 7, and 12-months compared to EC. We will assess a number of secondary outcomes, including additional clinical outcomes, functional outcomes, airway inflammation, and receipt of specific care measures including medication adjustments and treatment of and other comorbidities. We will also identify potential mediators and moderators of the intervention effect, and will evaluate the process of intervention implementation. At the completion of the study, the program will be better defined as a sustainable means to improve care and reduce morbidity for high risk teens with difficult to control asthma.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, the study involves creating an individualized asthma management plan, which might include adjustments to your current treatment.

What data supports the effectiveness of the treatment Telemedicine Enhanced Asthma Management for Teen Asthma?

Research shows that telemedicine and educational programs can help improve asthma management in teens by increasing medication adherence and asthma control. Studies like the SB-TEAM program and the ADAPT study highlight the benefits of using telehealth and mobile health tools to support self-management and improve health outcomes. ^{1 2 3 4 5}

Is Telemedicine Enhanced Asthma Management for Teen Asthma safe for humans?

The research articles provided do not contain specific safety data for Telemedicine Enhanced Asthma Management or its related programs. However, they emphasize the importance of educational and self-management programs in asthma care, which are generally considered safe and beneficial for improving asthma management. ^{6 7 8 9 10}

How does the Telemedicine Enhanced Asthma Management treatment differ from other asthma treatments?

This treatment is unique because it uses telemedicine to connect asthma specialists with schools, allowing for expert assessment and management of asthma directly in a school setting. This approach helps overcome barriers to accessing preventive asthma care and improves adherence to medication by providing convenient, school-based support. ^{4 5 11 12 13}

Eligibility Criteria

This trial is for teens aged 12-17 in Rochester with moderate to severe asthma that isn't well-controlled, despite treatment. They must not have other major health issues like heart disease or cystic fibrosis, be in foster care without guardian consent, involved in another asthma study, planning to move soon, or recently seen by an asthma specialist.

Inclusion Criteria

My doctor has diagnosed me with asthma.

My asthma is severe and not controlled by my current medication.

I am between 12 and 17 years old.

Exclusion Criteria

I have seen an asthma specialist in the last 3 months and prefer not to see another.

I can speak and understand either English or Spanish.

I do not have major health issues like heart disease or chronic lung problems that could affect asthma assessments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Telemedicine Visit

An individualized asthma management plan is developed via a real-time, synchronous school-based telemedicine visit connecting the teen to an asthma specialist

1 week

1 visit (in-person or virtual)

Directly Observed Therapy (DOT)

School-based or video-supported directly observed therapy to implement the medication plan and allow for teens to experience the benefits of consistent therapy

12 months

Regular school-based or virtual sessions

Follow-up

Follow-up telehealth visits with a nurse asthma educator to facilitate ongoing care and provide developmentally appropriate self-management support

12 months

Telehealth visits at 3, 5, 7, and 12 months

Treatment Details

Interventions

• Enhanced Care (EC)
• TEAM-UP for Teens

Trial Overview The TEAM-UP for Teens program is being tested against Enhanced Care (EC) control. It includes a school-based telemedicine visit with an asthma specialist to create a management plan, directly observed therapy at school or via video and follow-up visits with a nurse educator.

Participant Groups

Group I: TEAM-UP for Teens Intervention Experimental Treatment 1 Intervention

TEAM-UP for Teens pairs school-based and video-supported directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.

Group II: Enhanced Care Comparison Active Control 1 Intervention

Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

Findings from Research

The ADAPT study aims to improve medication adherence and asthma control in adolescents through an interactive smartphone app connected to community pharmacists, involving 352 participants in a cluster randomized controlled trial.

The app includes features like symptom tracking, medication reminders, and peer support, which are designed to enhance self-management and may provide valuable insights for managing other chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth intervention to support asthma self-management in adolescents: the ADAPT study. Kosse, RC., Bouvy, ML., de Vries, TW., et al.[2020]

Telehealth interventions, particularly mobile applications, have been shown to positively impact self-management outcomes for adolescents with allergic conditions, especially asthma, as evidenced by improvements in knowledge and quality of life across 18 studies.

The review identified key factors that enhance engagement in telehealth, such as interaction with peers or healthcare professionals, gamification, and tailored content, while also noting that these interventions were generally acceptable and feasible for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth interventions for transition to self-management in adolescents with allergic conditions: A systematic review. Sullivan, MO., Curtin, M., Flynn, R., et al.[2023]

Patient-focused educational programs that emphasize self-management strategies, such as individualized action plans and regular medical reviews, lead to the best health outcomes for asthma patients.

Teenagers with asthma are particularly vulnerable due to a lack of tailored management, highlighting the need for early and repeated educational interventions to improve adherence and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment education for patients with asthma]. Halimi, L., Bourdin, A., Mahjoub, BA., et al.[2016]

The New Mexico Pictorial Asthma Action Plan (NM PicAAP) was developed and validated to improve asthma management in children, particularly for those with low literacy, through telehealth services.

In a small study with seven youth, the implementation of NM PicAAP via telehealth resulted in increased asthma control scores over one month, suggesting it may be an effective tool for enhancing asthma care in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative Evaluation for Implementation of a Low Literacy Pictorial Asthma Action Plan Delivered via Telehealth Improves Asthma Control. Vallabhan, MK., Jimenez, EY., McCauley, GL., et al.[2021]

The SB-TEAM program, which includes supervised asthma medication administration and telemedicine visits, significantly increased the number of symptom-free days for children with persistent asthma, showing an improvement from 10.97 to 11.6 days per two weeks compared to usual care.

Children in the SB-TEAM group had a lower rate of emergency department visits and hospitalizations for asthma (7% vs 15%), indicating that this program not only improved symptoms but also reduced the need for urgent medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) Program on Asthma Morbidity: A Randomized Clinical Trial. Halterman, JS., Fagnano, M., Tajon, RS., et al.[2022]

A high-dose asthma self-management program for adolescents (ages 12-18) in Taiwan significantly improved self-efficacy, prevention behaviors, and medication adherence, indicating that more comprehensive interventions are beneficial.

The study used a scoring system to categorize participants based on the number of intervention components completed, demonstrating a clear dose-response relationship in the effectiveness of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multimodal approach to improve asthmatic adolescents' self-efficacy in Taiwan. Tseng, TJ., Wu, CJ.[2023]

Adolescents with asthma face unique challenges, including susceptibility to tobacco use and psychosocial issues, which complicate their asthma management and require tailored educational interventions.

Effective asthma care for adolescents should involve a multidisciplinary team approach, emphasizing self-management and autonomy, while following NHLBI guidelines to create personalized action plans for medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stressors and concerns in teen asthma. Randolph, C., Fraser, B.[2019]

A program designed to enhance asthma management through peer support was accepted by the community, indicating a positive reception for initiatives aimed at improving patient-physician collaboration in underserved areas.

The program was revised to focus more on the availability of care and educational events, successfully engaging parents and socially isolated families in asthma management activities, which could lead to better health outcomes for children with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of a community approach to asthma management: the Neighborhood Asthma Coalition (NAC). Fisher, EB., Strunk, RC., Sussman, LK., et al.[2019]

The Aironet educational program significantly reduced the number of asthma attacks in children with intermittent or mild persistent asthma, with an average of 1.65 attacks in the education group compared to 2.34 in the control group over 12 months.

Parents of children who experienced three or more asthma attacks at baseline showed a greater improvement in their knowledge of asthma after participating in the Aironet program, highlighting its effectiveness in both managing the disease and educating families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of a Long-term Educational Program for children with asthma - Aironet. A 1-yr randomized controlled trial. Indinnimeo, L., Bonci, E., Capra, L., et al.[2009]

In a study of 106 asthma patients, those using electronic asthma action plans (eAAP) supported by automated text messaging showed fewer asthma exacerbations (18%) compared to those with traditional written plans (AAP), although this difference was not statistically significant.

Patients in the eAAP group reported slightly better asthma control and quality of life scores compared to the AAP group, suggesting potential benefits of eAAP, but the study's small sample size indicates the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial on the impact of text messaging check-ins and a web-based asthma action plan versus a written action plan on asthma exacerbations. Poureslami, I., Shum, J., Lester, RT., et al.[2019]

A telemedicine program connecting asthma specialists with school-based asthma programs was found to be feasible and well-accepted, with 94% of participants rating it as good or excellent.

The study, involving 83 subjects over 32 weeks, showed significant improvements in family social activities and a reduction in asthma attacks, highlighting the potential benefits of expert asthma care access through telemedicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of telemedicine access to schools to facilitate expert assessment of children with asthma. Bergman, DA., Sharek, PJ., Ekegren, K., et al.[2021]

Telemedicine in school settings for asthma education showed positive or neutral effects on quality of life and self-management behaviors for children, with no reported negative effects from the interventions.

Clinical outcomes related to asthma management, such as airway inflammation and medication use, had mixed results, indicating that while some improvements were noted, further validation of these telemedicine methods is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedical Asthma Education and Health Care Outcomes for School-Age Children: A Systematic Review. Culmer, N., Smith, T., Stager, C., et al.[2021]

A systematic review of 22 studies involving 10,281 participants found that combined tele-case management significantly improved asthma control compared to usual care, with a standardized mean difference of 0.78.

Combined tele-case management was also the most effective method for enhancing the quality of life for asthma patients, indicating that telemedicine can be a valuable tool in managing asthma effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Telemedicine on Asthma Control and Patients' Quality of Life in Adults: A Systematic Review and Meta-analysis. Chongmelaxme, B., Lee, S., Dhippayom, T., et al.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

mHealth intervention to support asthma self-management in adolescents: the ADAPT study. [2020]

2. Denmark pubmed.ncbi.nlm.nih.gov

Telehealth interventions for transition to self-management in adolescents with allergic conditions: A systematic review. [2023]

3. France pubmed.ncbi.nlm.nih.gov

[Treatment education for patients with asthma]. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Formative Evaluation for Implementation of a Low Literacy Pictorial Asthma Action Plan Delivered via Telehealth Improves Asthma Control. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) Program on Asthma Morbidity: A Randomized Clinical Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A multimodal approach to improve asthmatic adolescents' self-efficacy in Taiwan. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Stressors and concerns in teen asthma. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of a community approach to asthma management: the Neighborhood Asthma Coalition (NAC). [2019]

9. England pubmed.ncbi.nlm.nih.gov

Clinical effects of a Long-term Educational Program for children with asthma - Aironet. A 1-yr randomized controlled trial. [2009]

10. England pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial on the impact of text messaging check-ins and a web-based asthma action plan versus a written action plan on asthma exacerbations. [2019]

11. Egypt pubmed.ncbi.nlm.nih.gov

The use of telemedicine access to schools to facilitate expert assessment of children with asthma. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Telemedical Asthma Education and Health Care Outcomes for School-Age Children: A Systematic Review. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

The Effects of Telemedicine on Asthma Control and Patients' Quality of Life in Adults: A Systematic Review and Meta-analysis. [2020]