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Completed

NCT Number: NCT03533764

Rural Asthma Effectiveness Study

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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASMA

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Medical University of South Carolina
  • NYU Langone Health
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 23, 2018
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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