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Rural Asthma Effectiveness Study

Primary Purpose

Asthma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASMA
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma Self-Management for Adolescents (ASMA), Community Health Workers (CHW)

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina (MUSC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Asthma Self-Management for Adolescents

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of night awakenings due to asthma symptoms
Teens and caregivers report the frequency of night awakenings in the prior weeks.
Number of days with asthma-related activity limitations
Teens and caregivers report the frequency of limitations due to asthma in the prior weeks.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2018
Last Updated
April 14, 2023
Sponsor
Columbia University
Collaborators
Medical University of South Carolina, NYU Langone Health, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03533764
Brief Title
Rural Asthma Effectiveness Study
Official Title
Translating an Evidence-based Urban Asthma Program for Rural Adolescents: Testing Effectiveness & Cost-effectiveness and Understanding Factors Associated With Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Medical University of South Carolina, NYU Langone Health, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma Self-Management for Adolescents (ASMA), Community Health Workers (CHW)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The research assistants who will interview study participants will be blind to study condition.
Allocation
Randomized
Enrollment
359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma Self-Management for Adolescents
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ASMA
Intervention Description
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 Outcome Measure Information:
Title
Number of night awakenings due to asthma symptoms
Description
Teens and caregivers report the frequency of night awakenings in the prior weeks.
Time Frame
Up to 1 year
Title
Number of days with asthma-related activity limitations
Description
Teens and caregivers report the frequency of limitations due to asthma in the prior weeks.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Bruzzese, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Available for up to 7 years from the end of the study.
IPD Sharing Access Criteria
Deidentified data.

Learn more about this trial

Rural Asthma Effectiveness Study

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