CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Efficacy of CAMP Air, a Web-based Asthma Intervention, Among Urban Adolescents With Uncontrolled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Controlling Asthma Program for Adolescents (CAMP Air)
* Behavioral: Attention Control Asthma Education Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to 1 of 2 groups, an e-health intervention group or an education only control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAMP Air<br>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. | Behavioral: Controlling Asthma Program for Adolescents (CAMP Air)<br>* 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.<br>* Other names: CAMP Air;|
| Active Comparator: Attention Control Asthma Education Intervention<br>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. | Behavioral: Attention Control Asthma Education Intervention<br>* Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.<br>* Other names: Asthma Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 
| Total number of days with asthma symptoms | Adolescents report the number of days they had asthma symptoms over the last 2 weeks. | Up to 1 year | 
| Total number of nights woken due to asthma | Adolescents report on how many nights asthma symptoms disrupted sleep or caused wakening over 2 weeks. | Up to 1 year | 
| 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. | Up to 1 year | 
| Total number of school absences due to asthma | Adolescents report on the number of days school was missed due to asthma over 2 weeks. | Up to 1 year | 
| 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. | Up to 1 year | 
| 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. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, E-Health, Intervention, Cost-effectiveness