The Efficacy of CAMP Air, a Web-based Asthma Intervention, Among Urban Adolescents With Uncontrolled Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Columbia University
- Enrollment
- 374
- Locations
- 1
- Primary Endpoint
- Mean score on the Asthma Control Questionnaire (ACQ-5)
Study Overview
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).
The investigators plan to interview adolescents as the primary respondent for all outcomes.
Caregivers and school personnel are invited to be interviewed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Mean score on the Asthma Control Questionnaire (ACQ-5)
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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 Outcomes
- Mean score on the Asthma Symptom Prevention Index(Up to 1 year)
- Mean score on the Asthma Management Index(Up to 1 year)
- Mean score on the Asthma Management Self-efficacy Index(Up to 1 year)
- Frequency of school absences due to asthma(Up to 1 year)
- Total number of school absences(Up to 1 year)
- Lung function - Overall functioning (Absolute ratio)(Up to 1 year)
- Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)(Up to 1 year)
- Lung function - Severity of impairment (FEV1% predicted)(Up to 1 year)
- Mean score on the Paediatric Asthma Quality of Life Questionnaire(Up to 1 year)
- Total number of oral steroid bursts(Up to 1 year)
- Total number of days with asthma symptoms(Up to 1 year)
- Total number of nights woken due to asthma(Up to 1 year)
- Total number of days with activity limitations due to asthma(Up to 1 year)
- Total number of school absences due to asthma(Up to 1 year)
- Mean score on the Asthma Symptom Prevention Index(Up to 1 year)
- Mean score on the Asthma Management Index(Up to 1 year)
- Mean score on the Asthma Management Self-efficacy Index(Up to 1 year)
- Proportion of adolescents taking controller medication(Up to 1 year)
- Lung function - Overall functioning (Absolute ratio)(Up to 1 year)
- Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)(Up to 1 year)
- Lung function - Severity of impairment (FEV1% predicted)(Up to 1 year)
- Mean score on the Paediatric Asthma Quality of Life Questionnaire(Up to 1 year)
- Total number of oral steroid bursts(Up to 1 year)
- Total number of days with asthma symptoms(Up to 1 year)
- Total number of nights woken due to asthma(Up to 1 year)
- Total number of days with activity limitations due to asthma(Up to 1 year)
- Total number of school absences due to asthma(Up to 1 year)
- Frequency of school absences due to asthma(Up to 1 year)
- Total number of school absences(Up to 1 year)
Investigators
Jean-Marie Bruzzese
Professor of Applied Developmental Psychology (in Nursing)
Columbia University