CAMP Air: Efficacy and Cost-effectiveness in Urban Adolescents

Asthma Clinical Trial

Official title:

The Efficacy of CAMP Air, a Web-based Asthma Intervention, Among Urban Adolescents With Uncontrolled Asthma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05091034
• Other study ID #: AAAT2274
• Secondary ID: 1R61HL151958-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. It will also examine barriers and facilitators to adoption and implementation of CAMP Air in high-schools.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 740
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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.
• Attention Control Asthma Education Intervention
Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.

Locations

Country	Name	City	State
United States	High schools in the 5 boroughs of New York City	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	3-C Institute for Social Development, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

Brownson 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)	The investigator 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.	Up to 1 year
Secondary	Lung function - Severity of impairment (FEV1% predicted)	The investigator 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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Total number of days with asthma symptoms	Adolescents report the number of days they had asthma symptoms over the last 2 weeks.	Up to 1 year
Secondary	Total number of nights woken due to asthma	Adolescents report on how many nights asthma symptoms disrupted sleep or caused wakening over 2 weeks.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Total number of school absences due to asthma	Adolescents report on the number of days school was missed due to asthma over 2 weeks.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Total number of school absences	The investigator will compute adolescents' total number of school absences, regardless of the reason, from attendance records obtained from each school.	Up to 1 year