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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CampAir
Information and Referral
Sponsored by
3-C Institute for Social Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Asthma, Adolescents, e-Health, Intervention

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CampAir Intervention

Information and Referral Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Night Wakenings Due to Asthma
Adolescent-reported rates of night wakenings due to asthma in the prior 2 weeks.

Secondary Outcome Measures

Urgent Health Utilization
Adolescents will report the number of asthma-related emergency department visits, hospitalizations and acute medical visits in the prior 2 months.
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.
Asthma self-management skills: Attack Management
Self-management indices for youth used in prior research will be used to assess attack management
Asthma self-management skills: Symptom Prevention
Self-management indices for youth used in prior research will be used to assess symptom prevention.
Asthma self-management skills: Asthma Self-Efficacy
Self-management indices for youth used in prior research will be used to assess asthma self-efficacy.
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.
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.
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.
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.
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.
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.
After-Scenario Questionnaire (ASQ)
Adolescents in the intervention condition will evaluate the technology-based product using the After-Scenario Questionnaire (ASQ).
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).
Technology Acceptance Model (TAM)
Adolescents in the intervention condition will evaluate the technology-based product using the Technology Acceptance Model (TAM) survey.
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.
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.
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.

Full Information

First Posted
June 27, 2016
Last Updated
June 27, 2017
Sponsor
3-C Institute for Social Development
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT02835300
Brief Title
Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
Acronym
CampAirPilot
Official Title
Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3-C Institute for Social Development
Collaborators
Columbia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Adolescents, e-Health, Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CampAir Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Information and Referral Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CampAir
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Information and Referral
Intervention Description
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.
Primary Outcome Measure Information:
Title
Night Wakenings Due to Asthma
Description
Adolescent-reported rates of night wakenings due to asthma in the prior 2 weeks.
Time Frame
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 Measure Information:
Title
Urgent Health Utilization
Description
Adolescents will report the number of asthma-related emergency department visits, hospitalizations and acute medical visits in the prior 2 months.
Time Frame
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)
Title
Asthma Morbidity
Description
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.
Time Frame
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)
Title
Asthma self-management skills: Attack Management
Description
Self-management indices for youth used in prior research will be used to assess attack management
Time Frame
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)
Title
Asthma self-management skills: Symptom Prevention
Description
Self-management indices for youth used in prior research will be used to assess symptom prevention.
Time Frame
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)
Title
Asthma self-management skills: Asthma Self-Efficacy
Description
Self-management indices for youth used in prior research will be used to assess asthma self-efficacy.
Time Frame
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)
Title
Quality of life (QOL)
Description
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.
Time Frame
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)
Title
Asthma control
Description
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.
Time Frame
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)
Title
Use of medication
Description
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.
Time Frame
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)
Title
Self-Management subscale of the Asthma Management and Medication Scale (AMMS)
Description
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.
Time Frame
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)
Title
Intervention feedback
Description
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.
Time Frame
2 weeks post intervention
Title
Software usage
Description
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.
Time Frame
Weekly for 7 weeks during intervention
Title
After-Scenario Questionnaire (ASQ)
Description
Adolescents in the intervention condition will evaluate the technology-based product using the After-Scenario Questionnaire (ASQ).
Time Frame
2 weeks post intervention
Title
Post-Study System Usability Questionnaire (PSSUQ)
Description
Adolescents in the intervention condition will evaluate the technology-based product using the Post-Study System Usability Questionnaire (PSSUQ).
Time Frame
2 weeks post intervention
Title
Technology Acceptance Model (TAM)
Description
Adolescents in the intervention condition will evaluate the technology-based product using the Technology Acceptance Model (TAM) survey.
Time Frame
2 weeks post intervention
Title
CampAir Evaluation
Description
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.
Time Frame
2 weeks post intervention
Title
Control Condition Material Usage
Description
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.
Time Frame
2 weeks post intervention
Title
Contamination
Description
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.
Time Frame
2 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Thomas, PhD
Organizational Affiliation
3C Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
3-C Institute for Social Development, dba 3C Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33004234
Citation
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.
Results Reference
derived

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Mobile Technology and Online Tools to Improve Asthma Control in Adolescents

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