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CompletedNCT02041013Updated Aug 24, 2015

Talking Card for Asthma

An interventional study of Taking Card in Asthma, sponsored by Children's Mercy Hospital Kansas City. Completed at 2 sites in United States. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2015-08-24.

Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
4 Years to 11 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Health Literacy
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 64 is below the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • No intervention
    No Talking Card

    Usual care of asthma by study clinician, including evaluation of asthma using C-ACT and clinical history, treatment using asthma action planning

  • Experimental
    Taking Card

    Usual care, as in comparison group, plus recordable Talking Card at each visit

    Other: Taking Card

Interventions

  • OtherTaking Card

    Recordable greeting card-style discharge instruction card

06

What researchers measure

Primary outcomes

  1. Asthma Control (C-ACT)

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

    Time frame: 3 months

Secondary outcomes

  1. Parental Card Use and Satisfaction

    Survey of parental card use and satisfaction with card performance, measured repeatedly across 3 visits

    Time frame: 3 months

07

Study locations

2 sites
  • University of South Florida
    Tampa, Florida 33620, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02041013
Lead sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of South Florida
Responsible party
John D Cowden (Associate Professor of Pediatrics, Children's Mercy Hospital Kansas City) — Principal investigator
First posted
Jan 20, 2014
Start date
Nov 2009
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Aug 24, 2015

Study contacts

John D Cowden, MD,MPH
principal investigator · Children's Mercy Hospital Kansas City
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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