Mobile Technology and Online Tools to Improve Asthma Control in Adolescents

NCT02835300 | Completed Phase 2 DMC

• 2 other identifiers: R44HL127826 PilotR44HL127826
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Adolescents; e-Health; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Urgent Health Utilization

  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

  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

  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

  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

  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)

Study Arms (2)

CampAir Intervention

EXPERIMENTAL

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

Information and Referral Control

ACTIVE COMPARATOR

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

Interventions

CampAir BEHAVIORAL

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.

CampAir Intervention

Information and Referral BEHAVIORAL

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.

Information and Referral Control

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Co-morbid diseases that affect lung functioning

Sponsors & Collaborators

• 3-C Institute for Social Development: lead
• Columbia University: collaborator

Study Sites (1)

3-C Institute for Social Development, dba 3C Institute

Durham, North Carolina, 27713, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• James Thomas, PhD

  3C Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 18, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

US (1)