NCT02839252

Brief Summary

The specific aims of this pilot study are to:

  1. 1.Evaluate the effectiveness of the asthma education intervention on asthma knowledge
  2. 2.Determine whether the asthma education intervention improves child and parent asthma treatment self-efficacy

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 4, 2024

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

July 15, 2016

Last Update Submit

October 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asthma knowledge

    This will be measured by a 10 question multiple choice survey

    Change in asthma knowledge immediately post-intervention and 1 month after intervention as compared with asthma knowledge prior to the intervention

Secondary Outcomes (1)

  • Asthma Self Efficacy

    Change in asthma self efficacy scores immediately post-intervention and 1 month after intervention as compared to pre-intervention self-efficacy scores

Study Arms (2)

Intervention Group

EXPERIMENTAL

After the baseline tools have been completed, the child will be given the Iggy Comic Book and trading cards. Parents and their children will then watch a 12-minute Iggy Video. At the completion of the video and prior to going home, the child and parent will complete the same 2 measures on asthma knowledge and self-efficacy. At 1-month after this clinic visit, the parent will be sent an email with a link to a Qualtrics survey that will contain a few supplemental questions to assess use of the intervention and the same 2 measures that the parent and the child completed at the initial visit.

Behavioral: Iggy and the Inhalers Asthma Education for Kids

Control Group

NO INTERVENTION

After the baseline tools have been completed, the parent and child will go home. At 1-month after the initial study clinic visit, the parent will be sent an email with a link to a Qualtrics survey that will contain a few supplemental questions to assess use of the intervention and the same 2 measures that the parent and the child completed at the initial visit.

Interventions

It is a comic book, trading cards, and stickers that teach kids about asthma. There is also a 12-minute cartoon video which teaches kids about asthma.

Intervention Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Followed in the Yacktman General Pediatrics Clinic at Advocate Children's Hospital - Park Ridge (ACH-PR)
  • Age 8 - 12 years
  • Documented diagnosis of asthma (any severity level)
  • Child and parent are English-speaking
  • Child is currently taking an asthma medication on either a daily or an as-needed basis
  • Parent permission/consent and child assent is obtained

You may not qualify if:

  • Child has a diagnosis of another chronic lung or cardiovascular disease
  • Child was assessed by parents or clinician to have a significant developmental delay, learning, or behavioral disability (e.g., autism spectrum)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yacktman Pediatrics

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 20, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

October 4, 2024

Record last verified: 2018-02

Locations