AsthmaNCT05091034
CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents
A study of Asthma, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Asthma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 12 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
High schools in the 5 boroughs of New York City
New York, New York, 10032
About this study
Official title: The Efficacy of CAMP Air, a Web-based Asthma Intervention, Among Urban Adolescents With Uncontrolled Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Controlling Asthma Program for Adolescents (CAMP Air), Attention Control Asthma Education Intervention
- Keywords
- Adolescents, E-Health, Intervention, Cost-effectiveness
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlling Asthma Program for Adolescents (CAMP Air)Behavioural
Also called CAMP Air
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.
Attention Control Asthma Education InterventionBehavioural
Also called Asthma Plus
Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.
| Study group | Role | What they receive |
|---|---|---|
| CAMP Air | Experimental | 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. Receives: Behavioral: Controlling Asthma Program for Adolescents (CAMP Air) |
| Attention Control Asthma Education Intervention | Active comparator | 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. Receives: Behavioral: Attention Control Asthma Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)
The investigators 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.
Measured: Up to 1 year
Lung function - Severity of impairment (FEV1% predicted)
The investigators 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Total number of school absences
The investigators will compute adolescents' total number of school absences, regardless of the reason, from attendance records obtained from each school.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start8 Nov 2021
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to 1 of 2 groups, an e-health intervention group or an education only control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- 3-C Institute for Social Development, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jean-Marie Bruzzese, Columbia University
- Investigators
- Jean-Marie Bruzzese, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091034
- Sponsor's protocol ID
- AAAT2274
- Other IDs
- 1R61HL151958-01A1
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Zahran HS, Bailey CM, Damon SA, Garbe PL, Breysse PN. Vital Signs: Asthma in Children - United States, 2001-2016. MMWR Morb Mortal Wkly Rep. 2018 Feb 9;67(5):149-155. doi: 10.15585/mmwr.mm6705e1.
PubMed 29420459Glick AF, Tomopoulos S, Fierman AH, Trasande L. Disparities in Mortality and Morbidity in Pediatric Asthma Hospitalizations, 2007 to 2011. Acad Pediatr. 2016 Jul;16(5):430-437. doi: 10.1016/j.acap.2015.12.014. Epub 2016 Jan 6.
PubMed 26768727Sullivan P, Ghushchyan VG, Navaratnam P, Friedman HS, Kavati A, Ortiz B, Lanier B. School absence and productivity outcomes associated with childhood asthma in the USA. J Asthma. 2018 Feb;55(2):161-168. doi: 10.1080/02770903.2017.1313273. Epub 2017 Apr 28.
PubMed 28453370Pearlman DN, Zierler S, Meersman S, Kim HK, Viner-Brown SI, Caron C. Race disparities in childhood asthma: does where you live matter? J Natl Med Assoc. 2006 Feb;98(2):239-47.
PubMed 16708510Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.
PubMed 19221156Park E, Kwon M. Health-Related Internet Use by Children and Adolescents: Systematic Review. J Med Internet Res. 2018 Apr 3;20(4):e120. doi: 10.2196/jmir.7731.
PubMed 29615385Bruzzese JM, Sheares BJ, Vincent EJ, Du Y, Sadeghi H, Levison MJ, Mellins RB, Evans D. Effects of a school-based intervention for urban adolescents with asthma. A controlled trial. Am J Respir Crit Care Med. 2011 Apr 15;183(8):998-1006. doi: 10.1164/rccm.201003-0429OC. Epub 2010 Dec 7.
PubMed 21139088Joseph CL, Peterson E, Havstad S, Johnson CC, Hoerauf S, Stringer S, Gibson-Scipio W, Ownby DR, Elston-Lafata J, Pallonen U, Strecher V; Asthma in Adolescents Research Team. A web-based, tailored asthma management program for urban African-American high school students. Am J Respir Crit Care Med. 2007 May 1;175(9):888-95. doi: 10.1164/rccm.200608-1244OC. Epub 2007 Feb 8.
PubMed 17290041Hollenbach JP, Cloutier MM. Implementing school asthma programs: Lessons learned and recommendations. J Allergy Clin Immunol. 2014 Dec;134(6):1245-1249. doi: 10.1016/j.jaci.2014.10.014.
PubMed 25482869Koh S, Lee M, Brotzman LE, Shelton RC. An orientation for new researchers to key domains, processes, and resources in implementation science. Transl Behav Med. 2020 Feb 3;10(1):179-185. doi: 10.1093/tbm/iby095.
PubMed 30445445Brownson RC, Colditz GA, Proctor EK. Dissemination and Implementation Research in Health: Translating Science to Practice (2nd Edition). New York: Oxford University Press; 2018.
Bruzzese JM, George M, Liu J, Evans D, Naar S, DeRosier ME, Thomas JM. The Development and Preliminary Impact of CAMP Air: A Web-based Asthma Intervention to Improve Asthma Among Adolescents. Patient Educ Couns. 2021 Apr;104(4):865-870. doi: 10.1016/j.pec.2020.09.011. Epub 2020 Sep 15.
PubMed 33004234