Rural Asthma Effectiveness Study

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: ASMA

• Registration Number: NCT03533764
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-23
• Study Start: 2018-11-18
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

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

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Exclusion Criteria

• Co-morbid diseases that affect lung functioning.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asthma Self-Management for Adolescents	ASMA	Asthma Self-Management for Adolescents (ASMA) consists of three complementary components: (1) an 8- week intervention for students; (2) caregiver education; and (3) education for students' medical providers.

Primary Outcome Measures

Name	Time	Method
Number of night awakenings due to asthma symptoms	Up to 1 year	Teens and caregivers report the frequency of night awakenings in the prior weeks.
Number of days with asthma-related activity limitations	Up to 1 year	Teens and caregivers report the frequency of limitations due to asthma in the prior weeks.

Trial Locations

Locations (1)

Medical University of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States