Online Asthma Self-Management for Children Aged 5-10 and Their Parents (ChildAsthma)

November 9, 2015 updated by: Susan Schroeder, Oregon Center for Applied Science, Inc.
The potential benefits of this research to public health include improved understanding of cultural factors in pediatric asthma self-management, improved self-management skills for children, and better asthma management skills for their parents. This could result in eased suffering and improved quality of life for millions of children and their families, and also reduce the economic burden borne by society in the forms of medical expenditures and lost productivity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This proposal will create an interactive multimedia (IMM) program designed to support the self-management efforts of asthmatic children aged 5-10 years and their families. This behavior change program will be designed to promote self-management by (a) increasing child and caregiver knowledge about asthma, (b) encouraging compliance with medication protocols and environmental controls, and (c) increasing self-efficacy to create and implement an Asthma Action Plan.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
622

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Center for Applied Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 5-10 with physican-diagnosed asthma and who had been prescribed any type of asthma medication, and one of their parents or primary caregivers. Parents and children needed to have access to an internet- and video-capable computer, and the parent needed to have a valid e-mail address in order to receive study-related correspondence.

Exclusion Criteria:

  • Only English-speaking participants were accepted because the program was developed only for English speakers. Children less than 5 years of age and older than 10 were excluded because the program is developed targeted to the developmental abilities and interests of children aged 5-10. There were no exclusions based on race/ethnicity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Lungtropolis
A game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents
Behavioral: Lungtropolis
A game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents
ACTIVE_COMPARATOR: Asthma educational booklet
Text-based asthma education booklet for parents and children in PDF format
Behavioral: Asthma educational booklet
Text-based asthma education booklet for parents and children in PDF format

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in children's knowledge about asthma
Time Frame: 45 days
A 5-item knowledge scale was developed with program-specific questions regarding asthma physiology, response to worsening symptoms, and asthma medications. These items used a 3-response choice scheme: "true," "not true," and "I don't know." The total number of items correct was summed to form the knowledge scale.
45 days
Change from baseline in parents' knowledge about asthma
Time Frame: 45 days
The Parent Knowledge Questionnaire (alpha = .81; Mesters, et al., 2003) was adapted to match program content, creating a 19-item knowledge scale covering basic knowledge about asthma (e.g., response to worsening symptoms, asthma medications, asthma triggers). The total number of correct items was summed to form the knowledge scale.
45 days
Change from baseline in children's attitudes toward medication
Time Frame: 45 days
A 5-item knowledge scale was developed with program-specific questions regarding asthma physiology, response to worsening symptoms, and asthma medications. These items used a 3-response choice scheme: "true," "not true," and "I don't know." The total number of items correct was summed to form the knowledge scale.
45 days
Change from baseline in parents' attitudes about asthma self-management
Time Frame: 45 days
The Asthma Attitude Survey (Mesters, et al., 2003), adapted to fit program content, assessed parents' attitudes regarding recognition of worsening symptoms, asthma medications, and triggers management. A 5-point Likert-type scale ranging from 1 (strongly agree) to 5 (strongly disagree) was used for responses, and items were summed to create an overall attitudes score.
45 days
Change from baseline in children's self-efficacy to improve asthma self-management
Time Frame: 45 days
Three self-efficacy items addressed each child's confidence in being able to recognize warning signs, use his/her quick-relief medicine immediately when having warning signs, and take medications as directed. Response choices were presented on a Likert-type scale ranging from 1 (no way, I can't do that) to 4 (sure, I can do that).
45 days
Change from baseline in parents' self-efficacy to improve asthma self-management
Time Frame: 45 days
The Parent Asthma Self-Efficacy survey (Bursch, et al., 2003), adapted to fit program content, used a 5-point Likert-type scale ranging from 1 (not at all sure) to 5 (completely sure) to assess parents' confidence about administering medications and responding to worsening symptoms.
45 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Asthma Control Test
Time Frame: 45 days
The Child-Asthma Control Test (C-ACT) for children 4-11 years old (Nathan, et al., 2004) was used to assess the child's current level of asthma control. The C-ACT contains 7 items-4 for the child's response and 3 for the parent's response, summed to create an asthma control score. Response choices for the children were presented on a 4-point Likert-type scale. The 3 parent items asked for frequency of symptoms over the past 4 weeks and were presented on a 6-point scale.
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Center for Applied Science, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBIR77R-2RR
  • R44HL077965-02A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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