CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents

NCT ID: NCT05091034

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-08

Study Completion Date

2027-06-30

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).

The investigators plan to interview adolescents as the primary respondent for all outcomes.

Caregivers and school personnel are invited to be interviewed.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to 1 of 2 groups, an e-health intervention group or an education only control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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CAMP Air

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.

Group Type EXPERIMENTAL

Controlling Asthma Program for Adolescents (CAMP Air)

Intervention Type BEHAVIORAL

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 Intervention

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.

Group Type ACTIVE_COMPARATOR

Attention Control Asthma Education Intervention

Intervention Type BEHAVIORAL

Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.

Interventions

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Controlling Asthma Program for Adolescents (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.

Intervention Type BEHAVIORAL

Attention Control Asthma Education Intervention

Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.

Intervention Type BEHAVIORAL

Other Intervention Names

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CAMP Air Asthma Plus

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3-C Institute for Social Development

INDUSTRY

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Jean-Marie Bruzzese

Professor of Applied Developmental Psychology (in Nursing)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Marie Bruzzese, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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High schools in the 5 boroughs of New York City

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29420459 (View on PubMed)

Glick 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.

Reference Type BACKGROUND
PMID: 26768727 (View on PubMed)

Sullivan 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.

Reference Type BACKGROUND
PMID: 28453370 (View on PubMed)

Pearlman 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.

Reference Type BACKGROUND
PMID: 16708510 (View on PubMed)

Akinbami 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.

Reference Type BACKGROUND
PMID: 19221156 (View on PubMed)

Park 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.

Reference Type BACKGROUND
PMID: 29615385 (View on PubMed)

Bruzzese 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.

Reference Type BACKGROUND
PMID: 21139088 (View on PubMed)

Joseph 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.

Reference Type BACKGROUND
PMID: 17290041 (View on PubMed)

Hollenbach 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.

Reference Type BACKGROUND
PMID: 25482869 (View on PubMed)

Koh 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.

Reference Type BACKGROUND
PMID: 30445445 (View on PubMed)

Brownson RC, Colditz GA, Proctor EK. Dissemination and Implementation Research in Health: Translating Science to Practice (2nd Edition). New York: Oxford University Press; 2018.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 33004234 (View on PubMed)

Other Identifiers

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1R61HL151958-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT2274

Identifier Type: -

Identifier Source: org_study_id

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