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Clinical Trials/NCT03533764
NCT03533764
Completed
Not Applicable

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

Columbia University1 site in 1 country359 target enrollmentNovember 18, 2018
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Columbia University
Enrollment
359
Locations
1
Primary Endpoint
Number of night awakenings due to asthma symptoms
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2018
End Date
January 19, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean-Marie Bruzzese

Professor of Applied Developmental Psychology (in Nursing)

Columbia University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of night awakenings due to asthma symptoms

Time Frame: 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

Time Frame: Up to 1 year

Teens and caregivers report the frequency of limitations due to asthma in the prior weeks.

Study Sites (1)

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