NCT02602392

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
622

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2 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

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2013

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

May 31, 2013

Last Update Submit

November 9, 2015

Conditions

Keywords

Self managementEducationChildrenCaregiversHealth Care Providers

Outcome Measures

Primary Outcomes (6)

  • Change from baseline in children's knowledge about asthma

    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

    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

    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

    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

    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

    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 Outcomes (1)

  • Change from baseline in Asthma Control Test

    45 days

Study Arms (2)

Lungtropolis

EXPERIMENTAL

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

Asthma educational booklet

ACTIVE COMPARATOR

Text-based asthma education booklet for parents and children in PDF format

Behavioral: Asthma educational booklet

Interventions

LungtropolisBEHAVIORAL

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

Lungtropolis

Text-based asthma education booklet for parents and children in PDF format

Asthma educational booklet

Eligibility Criteria

Age5 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Center for Applied Science

Eugene, Oregon, 97401, United States

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan Schroeder, MPH, MCHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 31, 2013

First Posted

November 11, 2015

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations