Talking Card for Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Taking Card

• Registration Number: NCT02041013
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

The research goal is to explore the use and effects of a custom-recordable audio discharge instruction card (Talking Card) in the pediatric health care setting. This study will address a primary, experimental research question: can pediatric asthma control be improved through the distribution of a custom-recorded audio asthma instruction card to parents at the health provider's office? Secondary, descriptive objectives will be to evaluate feasibility of Talking Card delivery and to collect and summarize parental reactions to the design and use of the audio discharge instruction card.

The specific aims of this study are:

1. To compare the change in mean Childhood Asthma Control Test (C-ACT) scores for children aged 4 through 11 years with uncontrolled asthma receiving a custom-recorded asthma instruction card to the change in mean C-ACT scores for those receiving usual care.

2. To measure the use and impressions of a custom-recordable audio asthma discharge instruction card among primary caregivers of children with uncontrolled asthma through quantitative and qualitative survey questions.

The investigators hypothesize that:

1) Asthma control in children 4 through 11 years of age with uncontrolled asthma, as measured by the C-ACT, will improve to a greater extent among those receiving a custom-recordable audio discharge instruction card than among those receiving usual care.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Child age 4 through 11 years old
• English-speaking primary caregiver
• Enrollment in Medicaid insurance company within 12 months of study recruitment (original Kansas City site criterion, removed on revision)
• Diagnosis of asthma (ICD-9 code 493.0) within 12 months of study recruitment
• Visit to study site clinic for asthma within 12 months of study recruitment

Exclusion Criteria

• History of premature birth less than 33 weeks gestation or requirement of a significant level of respiratory care including mechanical ventilation as a neonate
• Any major chronic illness including but not limited to non-skin cancer, cystic fibrosis, bronchiectasis, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neuro-developmental delay or behavioral disorders (excluding mild attention deficit hyperactivity disorder), or other conditions that would interfere with participation in the study
• Visit to any primary care provider giving asthma action plan advice during the previous month
• Anticipated departure from study area before study period ends (3-month follow-up)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taking Card	Taking Card	Usual care, as in comparison group, plus recordable Talking Card at each visit

Primary Outcome Measures

Name	Time	Method
Asthma Control (C-ACT)	3 months	Childhood Asthma Control Test (C-ACT) score, measured repeatedly across 3 visits

Secondary Outcome Measures

Name	Time	Method
Parental Card Use and Satisfaction	3 months	Survey of parental card use and satisfaction with card performance, measured repeatedly across 3 visits

Trial Locations

Locations (2)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States