CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents

NCT05091034 | Active Not Recruiting DMC

• 2 other identifiers: AAAT22741R61HL151958-01A1
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Adolescents; E-Health; Intervention; Cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• 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

Study Arms (2)

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.

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.

Behavioral: Attention Control Asthma Education Intervention

Interventions

Controlling Asthma Program for Adolescents (CAMP Air) 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.

Also known as: CAMP Air

CAMP Air

Attention Control Asthma Education Intervention BEHAVIORAL

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

Also known as: Asthma Plus

Attention Control Asthma Education Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• 3-C Institute for Social Development: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

High schools in the 5 boroughs of New York City

New York, New York, 10032, United States

Location

Related Publications (12)

• 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.

  PMID: 29420459 BACKGROUND

• 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.

  PMID: 26768727 BACKGROUND

• 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.

  PMID: 28453370 BACKGROUND

• 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.

  PMID: 16708510 BACKGROUND

• 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.

  PMID: 19221156 BACKGROUND

• 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.

  PMID: 29615385 BACKGROUND

• 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.

  PMID: 21139088 BACKGROUND

• 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.

  PMID: 17290041 BACKGROUND

• 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.

  PMID: 25482869 BACKGROUND

• 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.

  PMID: 30445445 BACKGROUND

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

  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.

  PMID: 33004234 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jean-Marie Bruzzese, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Developmental Psychology (in Nursing)

Model Details: Participants will be assigned to 1 of 2 groups, an e-health intervention group or an education only control group.

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: November 8, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Up to 7 years from the end of the study
• Access Criteria: De-identified

Locations

US (1)