Back to resultsCAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents
Primary Purpose
Asthma
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlling Asthma Program for Adolescents (CAMP Air)
Attention Control Asthma Education Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Adolescents, E-Health, Intervention, Cost-effectiveness
Eligibility Criteria
Inclusion Criteria: Adolescents must report
- A prior diagnosis of asthma;
- Asthma medication use in the last 12 months; and
- Symptoms consistent with uncontrolled asthma, defined as: in the last month (a) daytime symptoms 3+ days a week, (b) night awakenings 3+ nights per month, or (c) activity limitations 3+ days per week; OR in the last 12 months (d) 2+ unscheduled visits to a clinic or medical provider because having asthma symptoms, (e) 2+ ED visits; (f) 1+ hospitalization for asthma, or (g) taken oral or systemic steroids in the past year.
Exclusion Criteria:
- Pregnant teenagers due to the stress of adolescent pregnancy and hormonal changes of pregnancy that could change asthma control;
- Students enrolled in 12th grade because those randomized to the control group will not be in the school the following school year to receive CAMP Air;
- Teenagers with a co-morbid disease or condition that might affect lung function, such as cystic fibrosis or sickle cell anemia; and
- Teenagers with highly specialized learning needs (e.g., Down's syndrome, mental retardation, severe ADHD) which may preclude completion of the intervention or assessments.
Sites / Locations
- High schools in the 5 boroughs of New York City
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAMP Air
Attention Control Asthma Education Intervention
Arm Description
This is an e-health intervention consisting of 7 online modules. This behavioral intervention combines instruction, hands-on learning, interactive practice opportunities and tailored sessions. Teens learn about asthma, including treatment and triggers, the importance of seeing a medical provider and how they can overcome their specific barriers to seeing a medical provider, how they can talk to their parents about their asthma, and how they can care for their asthma, including managing stress and triggers. They also receive personalized feedback throughout the intervention and guidance on navigating the health care system.
The control intervention consists of 7 online sessions delivered via PowerPoint slides with voice-over. Teens receive information on asthma and other related health conditions, such as stress and sleep, and will be given a list of relevant websites to learn more about these topics. They will learn how to monitor their health using checklists and will be referred to a medical provider for asthma and other conditions; if they do have a medical provider, they will be provided with a referral. The asthma education component for this group lacks the interactive and personalized elements of CAMP Air, differentiating it from the experimental arm.
Outcomes
Primary Outcome Measures
Mean score on the Asthma Control Questionnaire (ACQ-5)
This measure, which is completed by the adolescents, assesses the adolescent's level of asthma control over the past week using 5-item version. The overall score is the mean of all questions; range = 0 - 6; lower scores indicate better control.
Total number of asthma-related urgent care visits
This measure assesses the adolescent's number of asthma-related visits to a medical provider for urgent or immediate treatment, emergency room visits, and hospitalizations over 3 months. Completed by adolescents. Higher counts indicate more urgent health care utilization.
Secondary Outcome Measures
Mean score on the Asthma Symptom Prevention Index
This measure assesses the number of steps adolescents take to prevent the onset of symptoms. Completed by the adolescents. Score range = 0 - 9; higher scores indicate better asthma self-care.
Mean score on the Asthma Management Index
This measure assesses the number of steps adolescents take to care for symptoms once they start. Completed by the adolescents. Score range = 0 - 7; higher scores indicate better asthma self-care.
Mean score on the Asthma Management Self-efficacy Index
This measure assesses the confidence adolescents have in caring for their asthma. Completed by adolescents. Score range = 0 - 7; higher scores indicate better asthma management self-efficacy.
Proportion of adolescents taking controller medication
Adolescents report the names of asthma medication they take, which will used to determine if controller medications are currently used.
Lung function - Overall functioning (Absolute ratio)
The investigator will use spirometry to assess how well adolescents' lungs work. Spirometry is a test that measures how much air people can hold in their lungs as well as how much air they can exhale, or blow out, and how fast they can blow it out. The investigator will calculate the FEV1/FVC ratio, which is a proportion of how much air a person can exhale from the lung in the first second relative to the total amount of air that comes out during a full exhale. Forced expiratory volume (FEV) is the amount of air exhaled from the lung in one second and forced vital capacity (FVC) is the total amount of air that comes out during a full exhale. A ratio of 0.75 indicates the lungs are working well.
Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)
The investigator will use spirometry to assess how well air is flowing out of the smaller airways of the lungs via FEF25%-75%, or the maximum mid-expiratory flow rate. Forced expiratory flow (FEF) is the speed at which air comes out of the lungs during the middle portion of a person's full exhale. FEF25-75% is the average speed at which air flows out of the lungs from the moment a person has exhaled 25% of their full breathe to the moment they have exhaled 75% of their full breathe; it is expressed as a percentage. FEF25-75% values of more than 60% suggest normal airflow.
Lung function - Severity of impairment (FEV1% predicted)
The investigator will use spirometry to assess how difficult it is for the adolescent's lungs to work when there is any indication that the lungs are not working properly. This will be measured as FEV1% predicted (FEV1% pred), and will be calculated by dividing the FEV1% of the adolescent by the average FEV1% in the population of adolescents with similar characteristics, such as age and sex. FEV1% is the FEV1/FVC absolute ratio expressed as a percentage. FEV1 is the amount of air exhaled from the lung in one second and FVC is the total amount of air that comes out during a full exhale. FEV1% pred values of 69 or less indicate moderate to severe difficulties in lung functioning; values of 70 or greater indicate mild difficulties in lung functioning.
Mean score on the Paediatric Asthma Quality of Life Questionnaire
Adolescents complete the Paediatric Asthma Quality of Life Questionnaire, which measures how they have felt in the past week because of their asthma. Comprised of 3 sub scales, which are combined for an overall mean score ranging from 1 - 7; higher scores indicate better pediatric asthma quality of life.
Total number of oral steroid bursts
Using the list of medications obtained from adolescents, the investigator will determine if there is use of oral steroids. If so, adolescents will also be asked how many times those medications were used over a period of 5 to 7 days in 3 months. Oral steroids are medications used to reduce acute inflammation and swelling in the lungs when other asthma medications are not working. A burst refers to a single period of 5 to 7 days in which a person takes oral steroids.
Total number of days with asthma symptoms
Adolescents report the number of days they had asthma symptoms over the last 2 weeks.
Total number of nights woken due to asthma
Adolescents report on how many nights asthma symptoms disrupted sleep or caused wakening over 2 weeks.
Total number of days with activity limitations due to asthma
Adolescents report on the number of days usual activities could not be carried out over 2 weeks due to asthma.
Total number of school absences due to asthma
Adolescents report on the number of days school was missed due to asthma over 2 weeks.
Frequency of school absences due to asthma
Adolescents reporting any school absences due to asthma in the last 2 weeks will also be asked how typical this attendance was over 3 months.
Total number of school absences
The investigator will compute adolescents' total number of school absences, regardless of the reason, from attendance records obtained from each school.
Full Information
NCT ID
NCT05091034
First Posted
October 12, 2021
Last Updated
April 14, 2023
Sponsor
Columbia University
Collaborators
3-C Institute for Social Development, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05091034
Brief Title
CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents
Official Title
The Efficacy of CAMP Air, a Web-based Asthma Intervention, Among Urban Adolescents With Uncontrolled Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
3-C Institute for Social Development, 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
Yes
5. Study Description
Brief Summary
This study will test the efficacy and cost-effectiveness of Controlling Asthma Program for Adolescents (CAMP Air), an e-health intervention, among urban predominately Black and Hispanic adolescents with uncontrolled asthma. It will also examine barriers and facilitators to adoption and implementation of CAMP Air in high-schools.
Detailed Description
Asthma prevalence and morbidity are high among adolescents, especially among Black and Hispanic youth. Yet, few interventions have been tested in adolescents. Despite the important role that technology plays in the lives of adolescents, only one intervention for adolescents with asthma is web-based. Additionally, research informing the scale-up of asthma interventions as well as their cost-effectiveness are scant. This study aims to address these treatment and methodological gaps by (1) systematically evaluating the efficacy of Controlling Asthma Program for Adolescents (CAMP Air), an e-health intervention, in urban adolescents with uncontrolled asthma; (2) assessing CAMP Air's cost-effectiveness; and (3) identifying multi-level factors associated with successful implementation of CAMP Air to inform its future scale-up. Due to COVID, at the start of the study, the spirometry data will not be collected from the participants (Secondary Outcomes 7 - 9).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Adolescents, E-Health, Intervention, Cost-effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to 1 of 2 groups, an e-health intervention group or an education only control group.
Masking
Outcomes Assessor
Masking Description
The principal investigator responsible for evaluating the efficacy of the intervention and the research assistants conducting assessment interviews with adolescents and their caregiver will be blind to assigned arm conditions.
Allocation
Randomized
Enrollment
740 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAMP Air
Arm Type
Experimental
Arm Description
This is an e-health intervention consisting of 7 online modules. This behavioral intervention combines instruction, hands-on learning, interactive practice opportunities and tailored sessions. Teens learn about asthma, including treatment and triggers, the importance of seeing a medical provider and how they can overcome their specific barriers to seeing a medical provider, how they can talk to their parents about their asthma, and how they can care for their asthma, including managing stress and triggers. They also receive personalized feedback throughout the intervention and guidance on navigating the health care system.
Arm Title
Attention Control Asthma Education Intervention
Arm Type
Active Comparator
Arm Description
The control intervention consists of 7 online sessions delivered via PowerPoint slides with voice-over. Teens receive information on asthma and other related health conditions, such as stress and sleep, and will be given a list of relevant websites to learn more about these topics. They will learn how to monitor their health using checklists and will be referred to a medical provider for asthma and other conditions; if they do have a medical provider, they will be provided with a referral. The asthma education component for this group lacks the interactive and personalized elements of CAMP Air, differentiating it from the experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
Controlling Asthma Program for Adolescents (CAMP Air)
Other Intervention Name(s)
CAMP Air
Intervention Description
Controlling Asthma Program for Adolescents (CAMP Air) is an e-health intervention grounded in social cognitive theory and motivational interviewing to guide teens through asthma self-care and how to navigate the health care system. It makes use of various interactive and personalized approaches.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Asthma Education Intervention
Other Intervention Name(s)
Asthma Plus
Intervention Description
Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.
Primary Outcome Measure Information:
Title
Mean score on the Asthma Control Questionnaire (ACQ-5)
Description
This measure, which is completed by the adolescents, assesses the adolescent's level of asthma control over the past week using 5-item version. The overall score is the mean of all questions; range = 0 - 6; lower scores indicate better control.
Time Frame
Up to 1 year
Title
Total number of asthma-related urgent care visits
Description
This measure assesses the adolescent's number of asthma-related visits to a medical provider for urgent or immediate treatment, emergency room visits, and hospitalizations over 3 months. Completed by adolescents. Higher counts indicate more urgent health care utilization.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Mean score on the Asthma Symptom Prevention Index
Description
This measure assesses the number of steps adolescents take to prevent the onset of symptoms. Completed by the adolescents. Score range = 0 - 9; higher scores indicate better asthma self-care.
Time Frame
Up to 1 year
Title
Mean score on the Asthma Management Index
Description
This measure assesses the number of steps adolescents take to care for symptoms once they start. Completed by the adolescents. Score range = 0 - 7; higher scores indicate better asthma self-care.
Time Frame
Up to 1 year
Title
Mean score on the Asthma Management Self-efficacy Index
Description
This measure assesses the confidence adolescents have in caring for their asthma. Completed by adolescents. Score range = 0 - 7; higher scores indicate better asthma management self-efficacy.
Time Frame
Up to 1 year
Title
Proportion of adolescents taking controller medication
Description
Adolescents report the names of asthma medication they take, which will used to determine if controller medications are currently used.
Time Frame
Up to 1 year
Title
Lung function - Overall functioning (Absolute ratio)
Description
The investigator will use spirometry to assess how well adolescents' lungs work. Spirometry is a test that measures how much air people can hold in their lungs as well as how much air they can exhale, or blow out, and how fast they can blow it out. The investigator will calculate the FEV1/FVC ratio, which is a proportion of how much air a person can exhale from the lung in the first second relative to the total amount of air that comes out during a full exhale. Forced expiratory volume (FEV) is the amount of air exhaled from the lung in one second and forced vital capacity (FVC) is the total amount of air that comes out during a full exhale. A ratio of 0.75 indicates the lungs are working well.
Time Frame
Up to 1 year
Title
Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)
Description
The investigator will use spirometry to assess how well air is flowing out of the smaller airways of the lungs via FEF25%-75%, or the maximum mid-expiratory flow rate. Forced expiratory flow (FEF) is the speed at which air comes out of the lungs during the middle portion of a person's full exhale. FEF25-75% is the average speed at which air flows out of the lungs from the moment a person has exhaled 25% of their full breathe to the moment they have exhaled 75% of their full breathe; it is expressed as a percentage. FEF25-75% values of more than 60% suggest normal airflow.
Time Frame
Up to 1 year
Title
Lung function - Severity of impairment (FEV1% predicted)
Description
The investigator will use spirometry to assess how difficult it is for the adolescent's lungs to work when there is any indication that the lungs are not working properly. This will be measured as FEV1% predicted (FEV1% pred), and will be calculated by dividing the FEV1% of the adolescent by the average FEV1% in the population of adolescents with similar characteristics, such as age and sex. FEV1% is the FEV1/FVC absolute ratio expressed as a percentage. FEV1 is the amount of air exhaled from the lung in one second and FVC is the total amount of air that comes out during a full exhale. FEV1% pred values of 69 or less indicate moderate to severe difficulties in lung functioning; values of 70 or greater indicate mild difficulties in lung functioning.
Time Frame
Up to 1 year
Title
Mean score on the Paediatric Asthma Quality of Life Questionnaire
Description
Adolescents complete the Paediatric Asthma Quality of Life Questionnaire, which measures how they have felt in the past week because of their asthma. Comprised of 3 sub scales, which are combined for an overall mean score ranging from 1 - 7; higher scores indicate better pediatric asthma quality of life.
Time Frame
Up to 1 year
Title
Total number of oral steroid bursts
Description
Using the list of medications obtained from adolescents, the investigator will determine if there is use of oral steroids. If so, adolescents will also be asked how many times those medications were used over a period of 5 to 7 days in 3 months. Oral steroids are medications used to reduce acute inflammation and swelling in the lungs when other asthma medications are not working. A burst refers to a single period of 5 to 7 days in which a person takes oral steroids.
Time Frame
Up to 1 year
Title
Total number of days with asthma symptoms
Description
Adolescents report the number of days they had asthma symptoms over the last 2 weeks.
Time Frame
Up to 1 year
Title
Total number of nights woken due to asthma
Description
Adolescents report on how many nights asthma symptoms disrupted sleep or caused wakening over 2 weeks.
Time Frame
Up to 1 year
Title
Total number of days with activity limitations due to asthma
Description
Adolescents report on the number of days usual activities could not be carried out over 2 weeks due to asthma.
Time Frame
Up to 1 year
Title
Total number of school absences due to asthma
Description
Adolescents report on the number of days school was missed due to asthma over 2 weeks.
Time Frame
Up to 1 year
Title
Frequency of school absences due to asthma
Description
Adolescents reporting any school absences due to asthma in the last 2 weeks will also be asked how typical this attendance was over 3 months.
Time Frame
Up to 1 year
Title
Total number of school absences
Description
The investigator will compute adolescents' total number of school absences, regardless of the reason, from attendance records obtained from each school.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents must report
A prior diagnosis of asthma;
Asthma medication use in the last 12 months; and
Symptoms consistent with uncontrolled asthma, defined as: in the last month (a) daytime symptoms 3+ days a week, (b) night awakenings 3+ nights per month, or (c) activity limitations 3+ days per week; OR in the last 12 months (d) 2+ unscheduled visits to a clinic or medical provider because having asthma symptoms, (e) 2+ ED visits; (f) 1+ hospitalization for asthma, or (g) taken oral or systemic steroids in the past year.
Exclusion Criteria:
Pregnant teenagers due to the stress of adolescent pregnancy and hormonal changes of pregnancy that could change asthma control;
Students enrolled in 12th grade because those randomized to the control group will not be in the school the following school year to receive CAMP Air;
Teenagers with a co-morbid disease or condition that might affect lung function, such as cystic fibrosis or sickle cell anemia; and
Teenagers with highly specialized learning needs (e.g., Down's syndrome, mental retardation, severe ADHD) which may preclude completion of the intervention or assessments.
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
High schools in the 5 boroughs of New York City
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The 3-C Institute will house the web-based intervention on their server, and conduct all data management activities for the study. Data stored electronically and shared between sites will be de-identified by HIPAA standards using the "safe-harbor" method (i.e., all 18 identifiers will be stripped) whenever possible, otherwise it will be sent encrypted. Data will be stored on a password-protected webserver.
IPD Sharing Time Frame
Up to 7 years from the end of the study
IPD Sharing Access Criteria
De-identified
Citations:
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CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents
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