Clinical trial NCT03533764: Rural Asthma Effectiveness Study
Official title: Translating an Evidence-based Urban Asthma Program for Rural Adolescents: Testing Effectiveness & Cost-effectiveness and Understanding Factors Associated With Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma Self-Management for Adolescents (ASMA)
Community Health Workers (CHW)
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: NYU Langone Health
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-23
Enrollment: 359
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of night awakenings due to asthma symptoms
timeFrame: Up to 1 year
measure: Number of days with asthma-related activity limitations
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
Study officials:
affiliation: Columbia University
name: Jean-Marie Bruzzese, PhD
role: PRINCIPAL_INVESTIGATOR
References: