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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: ASMA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||426 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The research assistants who will interview study participants will be blind to study condition.|
|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|
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.
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.
- 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.
- 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.
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
|United States, South Carolina|
|Medical University of South Carolina (MUSC)|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Jean-Marie Bruzzese, PhD||Columbia University|