NCT02816216

Brief Summary

This project will fully develop and 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2016

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

June 22, 2016

Last Update Submit

January 27, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Product Evaluation

    Participants will complete a brief online survey to rate the content modules and other components of the CampAir program in the areas of (a) engagement, (b) quality of content, (c) quality of flow, (d) value, (e) usefulness, (f) relevance to real-life, (g) usability. Open-ended questions will also be included to gather qualitative comments and recommendations for each area assessed. This measure will be repeated for each review with questions tailored to the particular components and modules reviewed.

    Once per module (One Evaluation per week for seven weeks)

Study Arms (1)

End User Iterative Testing - CampAir

OTHER

To ensure the software and website function as intended, investigators will systematically test each of the seven CampAir modules with target end users. Participants will review one module per week for seven weeks. As part of each module, participants will also complete a daily asthma checklist. Following the review of each module, participants will be prompted to complete measures assessing technology acceptability and usability and product quality. Results will be used to modify and finalize the user interface and navigation to maximize usability.

Behavioral: CampAir

Interventions

CampAirBEHAVIORAL

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.

End User Iterative Testing - CampAir

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between ages 13 - 18 years
  • Prior Asthma diagnosis
  • Use of a prescribed Asthma medication in the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3-C Institute for Social Development

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: 33004234DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Janey S McMillen, PhD

    3-C Institute for Social Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 28, 2016

Study Start

May 1, 2016

Primary Completion

October 5, 2016

Study Completion

October 5, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

US(1)