Rural Asthma Effectiveness Study

NCT03533764 | Completed

• 2 other identifiers: AAAR4130R01HL136753
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma Self-Management for Adolescents (ASMA); Community Health Workers (CHW)

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Asthma Self-Management for Adolescents

EXPERIMENTAL

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.

Behavioral: ASMA

Attention Control

NO INTERVENTION

In 3 group sessions and 5 one-on-one sessions, held at school during the school day, students will receive information about asthma and other health topics relevant to adolescents (e.g., nutrition, safety). They will learn to monitor their health by using diaries to record behaviors, such as what they eat, and/or their sleep patterns. Students will be referred to their medical providers for asthma and other health concerns; if they do not have a provider, they are given referrals in their community.

Interventions

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.

Asthma Self-Management for Adolescents

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Co-morbid diseases that affect lung functioning.

Sponsors & Collaborators

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

Study Sites (1)

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

MUSK protein, human

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jean-Marie Bruzzese, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants who will interview study participants will be blind to study condition.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Developmental Psychology (in Nursing)

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: November 18, 2018
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available for up to 7 years from the end of the study.
• Access Criteria: Deidentified data.

Locations

US (1)