Clinical trial NCT02041013: Talking Card for Asthma
Official title: The Talking Card for Asthma: A Recordable Audio Discharge Instruction Device to Improve Asthma Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Health Literacy
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2014-01-20
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Asthma Control (C-ACT)
timeFrame: 3 months
Secondary outcomes:
measure: Parental Card Use and Satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: John D Cowden, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: