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Rural Asthma Effectiveness Study

Translating an Evidence-based Urban Asthma Program for Rural Adolescents: Testing Effectiveness & Cost-effectiveness and Understanding Factors Associated With Implementation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03533764
Enrollment
359
Registered
2018-05-23
Start date
2018-11-18
Completion date
2024-01-19
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma Self-Management for Adolescents (ASMA), Community Health Workers (CHW)

Brief summary

The investigators will test if their intervention, Asthma Self-Management for Adolescents (ASMA), an 8-week, high school-based intervention for teenagers, improves asthma in rural high school students with uncontrolled asthma when delivered by CHWs. The investigators will also test the cost-effectiveness of ASMA, and examine the barriers and facilitators of ASMA's widespread implementation.

Detailed description

Asthma, the most common pediatric chronic illness, has high prevalence and morbidity among adolescents. Despite this, there are few interventions for high school students, and none have been tested when delivered by Community Health Workers (CHWs) or in rural areas. This represents a significant limitation because the CHW model has been shown to be successful in clinic- and home-based interventions. Also, rural adolescents with asthma represent a very large population. Given the high prevalence of asthma in this group, this oversight is a significant public health concern. Cost effectiveness analyses and implementation research are also lacking in asthma intervention research. This study addresses these treatment and methodological gaps. The investigators developed and established the efficacy of Asthma Self-Management for Adolescents (ASMA), an 8-week, high school-based intervention, in urban Hispanic and African American adolescents.

Interventions

BEHAVIORALASMA

ASMA, grounded in social cognitive theory and utilizing motivational interviewing techniques, guides adolescents in their transition to being consumers and teaching them to navigate the health system, including overcoming challenges to health care access. Briefly, it consists of three complementary components: (1) an 8- week intervention for students; (2) caregiver education; and (3) education for students' medical providers.

Sponsors

Medical University of South Carolina
CollaboratorOTHER
NYU Langone Health
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

The research assistants who will interview study participants will be blind to study condition.

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adolescents who are at least 13.0 at the time of consent * Teenager reports having a prior asthma diagnosis, and in the last 12 months has: (a) used prescribed asthma medication and (b) uncontrolled asthma, defined as: (i) symptoms 3+ days a week; (ii) night awakenings 3+ nights per month; (iii) 2+ ED visits; or (iv) 1+ hospitalization for asthma; and * Adolescents are English proficient

Exclusion criteria

• Co-morbid diseases that affect lung functioning.

Design outcomes

Primary

MeasureTime frameDescription
Number of night awakenings due to asthma symptomsUp to 1 yearTeens and caregivers report the frequency of night awakenings in the prior weeks.
Number of days with asthma-related activity limitationsUp to 1 yearTeens and caregivers report the frequency of limitations due to asthma in the prior weeks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026