Clinical trial NCT05091034: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Asthma
Keywords: Adolescents
E-Health
Intervention
Cost-effectiveness
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: 3-C Institute for Social Development
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-10-25
Enrollment: 740
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to 1 of 2 groups, an e-health intervention group or an education only control group.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Mean score on the Asthma Control Questionnaire (ACQ-5)
timeFrame: Up to 1 year
measure: Total number of asthma-related urgent care visits
timeFrame: Up to 1 year
Secondary outcomes:
measure: Mean score on the Asthma Symptom Prevention Index
timeFrame: Up to 1 year
measure: Mean score on the Asthma Management Index
timeFrame: Up to 1 year
measure: Mean score on the Asthma Management Self-efficacy Index
timeFrame: Up to 1 year
measure: Proportion of adolescents taking controller medication
timeFrame: Up to 1 year
measure: Lung function - Overall functioning (Absolute ratio)
timeFrame: Up to 1 year
measure: Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)
timeFrame: Up to 1 year
measure: Lung function - Severity of impairment (FEV1% predicted)
timeFrame: Up to 1 year
measure: Mean score on the Paediatric Asthma Quality of Life Questionnaire
timeFrame: Up to 1 year
measure: Total number of oral steroid bursts
timeFrame: Up to 1 year
measure: Total number of days with asthma symptoms
timeFrame: Up to 1 year
measure: Total number of nights woken due to asthma
timeFrame: Up to 1 year
measure: Total number of days with activity limitations due to asthma
timeFrame: Up to 1 year
measure: Total number of school absences due to asthma
timeFrame: Up to 1 year
measure: Frequency of school absences due to asthma
timeFrame: Up to 1 year
measure: Total number of school absences
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: High schools in the 5 boroughs of New York City
state: New York
Study officials:
affiliation: Columbia University
name: Jean-Marie Bruzzese, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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