Talking Card for Asthma

Study Overview
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Brief Summary
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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: 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. 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.

Official Title
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The Talking Card for Asthma: A Recordable Audio Discharge Instruction Device to Improve Asthma Control

Conditions
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Asthma

Intervention / Treatment
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* Other: Taking Card


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Talking Card<br>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<br>Usual care, as in comparison group, plus recordable Talking Card at each visit | Other: Taking Card<br>* Recordable greeting card-style discharge instruction card<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control (C-ACT) | Childhood Asthma Control Test (C-ACT) score, measured repeatedly across 3 visits | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Card Use and Satisfaction | Survey of parental card use and satisfaction with card performance, measured repeatedly across 3 visits | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Health Literacy