Mobile Technology and Online Tools to Improve Asthma Control in Adolescents

Asthma Clinical Trial

— CampAirPilot  

Official title:

Mobile Technology and Online Tools to Improve Asthma Control in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835300
• Other study ID #: R44HL127826 Pilot
• Secondary ID: R44HL127826
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2016
• Last updated: June 27, 2017
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: 3-C Institute for Social Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	3-C Institute for Social Development, dba 3C Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
3-C Institute for Social Development	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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