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Rural Asthma Effectiveness Study

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ClinicalTrials.gov Identifier: NCT03533764
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Medical University of South Carolina
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jean-Marie Bruzzese, Columbia University

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: ASMA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The research assistants who will interview study participants will be blind to study condition.
Primary Purpose: Other
Official Title: Translating an Evidence-based Urban Asthma Program for Rural Adolescents: Testing Effectiveness & Cost-effectiveness and Understanding Factors Associated With Implementation
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Asthma Self-Management for Adolescents
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
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.

No Intervention: Attention Control
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.



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533764


Locations
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United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Columbia University
Medical University of South Carolina
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jean-Marie Bruzzese, PhD Columbia University

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Responsible Party: Jean-Marie Bruzzese, Associate Professor of Applied Developmental Psychology (in Nursing), Columbia University
ClinicalTrials.gov Identifier: NCT03533764     History of Changes
Other Study ID Numbers: AAAR4130
R01HL136753 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data shared between sites will be de-identified by HIPAA standards using the "safe-harbor" method (i.e., all 18 identifiers will be stripped) prior to being scanned and stored on a password-protected webserver.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Available for up to 7 years from the end of the study.
Access Criteria: Deidentified data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-Marie Bruzzese, Columbia University:
Asthma Self-Management for Adolescents (ASMA)
Community Health Workers (CHW)
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases