Rural Asthma Effectiveness Study

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03533764
• Other study ID #: AAAR4130
• Secondary ID: R01HL136753
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2018
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 359
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• ASMA
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of night awakenings due to asthma symptoms	Teens and caregivers report the frequency of night awakenings in the prior weeks.	Up to 1 year
Primary	Number of days with asthma-related activity limitations	Teens and caregivers report the frequency of limitations due to asthma in the prior weeks.	Up to 1 year