Mobile Technology and Online Tools to Improve Asthma Control in Adolescents (CampAirPilot)

This project will preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: CampAir; Behavioral: Information and Referral

Detailed Description

Asthma has high prevalence and morbidity among adolescents, especially urban Hispanic and African American teenagers. Despite this, few interventions have specifically targeted adolescents. School-based and web-based asthma interventions have shown to be effective with younger children, yet few have been developed and tested for adolescents. Investigators have developed Camp Air, an engaging dynamic e-learning intervention to help adolescents with uncontrolled asthma to manage their illness and to improve their asthma control. Camp Air consists of seven online modules with one module being completed each week over seven weeks. Each module provides a brief introduction to the topics and strategies focused on in that module followed by a set of interactive exercises and games for practice and personalized feedback. The investigators will conduct a two group randomized pilot trial with up to 80, 9th - 12th graders with uncontrolled asthma in order (a) to assess the preliminary intervention effects of Camp Air, and (b) to evaluate the feasibility and acceptability of Camp Air. In order to evaluate CAMP Air's utility as both a school- and home-based intervention, adolescents will be enrolled from two sites: 1) NYC public schools (n=up to 38), or 2) the national asthma community at large (n=up to 42). Investigators will also evaluate the reach, acceptability, generalizability, and sustainability of Camp Air using the RE-AIM approach. Investigators hypothesize that over one month post-intervention, relative to controls, Camp Air participants will show significantly greater improvement in asthma-related outcomes. Investigators also hypothesize that ratings and software usage indices will demonstrate that Camp Air is a feasible, usable, and acceptable intervention for use with adolescents. Investigators will also explore evidence of a dose-response in which participants who spend more time engaged with the e-training materials show greater positive change.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • 3-C Institute for Social Development, dba 3C Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 13 - 18 years
• Prior asthma diagnosis
• Use of a prescribed asthma medication in the past 12 months
• Uncontrolled asthma, defined as (1) daytime symptoms 3+ days per week, (2) night awakenings 1+ nights per week, or (3) 2+ exacerbation events, i.e. 2+ steroid bursts; 2+ emergency department visits, or 1+ hospitalization for asthma.

Exclusion Criteria:

• Co-morbid diseases that affect lung functioning

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CampAir Intervention; Adolescents assigned to receive ASMA 2.0 will receive all seven modules over the two month trial, completing one module per week. Adolescents will be assigned one module per week, but will have free access to all completed modules for the duration of the two-month trial. Each module is expected to take between 30-40 minutes to complete, although adolescents will be able to engage with the software for as long as desired.	Behavioral: CampAir; CampAir is a dynamic e-learning intervention to help adolescents with uncontrolled asthma to manage their illness and to improve their asthma control. CampAir consists of seven online modules with one module being completed each week over seven weeks. Each module provides a brief introduction to the topics and strategies focused on in that module followed by a set of interactive exercises and games for practice and personalized feedback.
Active Comparator: Information and Referral Control; Adolescents assigned to the information-and-referral control condition will be provided access to existing generic asthma education websites. They will also be referred to their medical providers for asthma. After the completion of the trial, all participants will receive access to CampAir.	Behavioral: Information and Referral; The information and referral comparator condition will provide access to existing generic asthma education websites. They will also be referred to their medical providers for asthma. After the completion of the trial, all participants will have access to CampAir.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Night Wakenings Due to Asthma	Adolescent-reported rates of night wakenings due to asthma in the prior 2 weeks.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urgent Health Utilization	Adolescents will report the number of asthma-related emergency department visits, hospitalizations and acute medical visits in the prior 2 months.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Asthma Morbidity	Adolescents will report the number of days in the past 2 weeks (1) they experienced symptoms of wheeze, cough, shortness of breath, or chest tightness; (2) they could not carry out normal activities because of asthma; and (3) absences from school due to asthma.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Asthma self-management skills: Attack Management	Self-management indices for youth used in prior research will be used to assess attack management	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Asthma self-management skills: Symptom Prevention	Self-management indices for youth used in prior research will be used to assess symptom prevention.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Asthma self-management skills: Asthma Self-Efficacy	Self-management indices for youth used in prior research will be used to assess asthma self-efficacy.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Quality of life (QOL)	QOL in the past week will be assessed with the widely used validated Paediatric Asthma Quality of Life Questionnaire (PAQLQ), which has 23 items in 3 domains: (a) symptoms; (b) emotions, including feelings about self and relationships with siblings or friends; and (c) degree of interference with physical activities.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Asthma control	Investigators will use Juniper's Asthma Control Questionnaire (ACQ), a 6-item widely used instrument in pediatric research, shown to be sensitive to treatment effects. Respondents rate their symptoms, night awakening and use of bronchodilators over the previous 7 days on a 7-point scale.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Use of medication	Adolescents will report the names of their medications, which will be used to determine if oral steroids and controller medications are used; if oral steroids are reported, investigators will also ask how many times they have been used since the last survey to determine the frequency of steroid bursts.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Self-Management subscale of the Asthma Management and Medication Scale (AMMS)	Investigators will use the Self-Management subscale of the Asthma Management and Medication Scale (AMMS), a brief, validated self-report instrument that measures asthma adherence behaviors.	To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up)
Intervention feedback	Adolescents in both conditions will provide feedback regarding their experiences during the trial period. On a 5-point scale (1=Strongly Disagree to 5=Strongly Agree), respondents will rate the degree to which their experience was: (a) useful for increasing knowledge of asthma and asthma-related symptoms; (b) useful for learning self-management skills; (c) helped decrease the impact of asthma on daily activities; (e) valuable for adolescents with asthma; (f) engaging for adolescents; (g) innovative compared to alternatives; (h) better than alternatives. Participants will also be asked to provide written comments, listing specific concerns or problems. Follow-up interviews at school or via telephone by trained research assistants will be conducted to clarify responses and gather additional details, as needed.	2 weeks post intervention
Software usage	The system will collect usage data throughout the trial to document when and how the website and software are being used. Whenever adolescents access Camp Air, information about that interaction will be captured and time stamped. Usage statistics will be collected via a combination of HTTP access logs and session cookies to document the number of times a given webpage/tool/resource is accessed, amount of time spent in a given activity, and sequence of steps taken to complete a task.	Weekly for 7 weeks during intervention
After-Scenario Questionnaire (ASQ)	Adolescents in the intervention condition will evaluate the technology-based product using the After-Scenario Questionnaire (ASQ).	2 weeks post intervention
Post-Study System Usability Questionnaire (PSSUQ)	Adolescents in the intervention condition will evaluate the technology-based product using the Post-Study System Usability Questionnaire (PSSUQ).	2 weeks post intervention
Technology Acceptance Model (TAM)	Adolescents in the intervention condition will evaluate the technology-based product using the Technology Acceptance Model (TAM) survey.	2 weeks post intervention
CampAir Evaluation	Adolescents in the intervention condition will evaluate the technology-based product using a 5-point scale from 1=Not at all to 5=Extremely) the quality of ASMA 2.0 in the following areas: (a) user friendly; (b) easy to navigate; (c) appealing graphic design; (d) easy to follow directions; (e) jargon free; (f) engaging; (g) high quality content; (h) high value content; (i) relevance to real-life; (j) login functions; (k) search functions; and (l) help functions.	2 weeks post intervention
Control Condition Material Usage	Adolescents assigned to the information-and-referral control condition will answer six questions to assess their use of the educational resources provided to them during the intervention phase.	2 weeks post intervention
Contamination	Adolescents in the control group in the school sample will be asked three questions about their exposure to CAMP Air, while adolescents in the treatment group in the school sample will be asked questions about their discussing the intervention with other teens in the school and/or sharing the materials with them. Adolescents in the community sample will not be asked contamination-related questions.	2 weeks post intervention

Collaborators and Investigators

• Sponsor: 3-C Institute for Social Development
• Collaborators: Columbia University
• Investigators: Principal Investigator: James Thomas, PhD, 3C Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Asthma; Intervention; e-Health
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: R44HL127826 Pilot; R44HL127826 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided