Talking Card for Asthma

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Taking Card

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Recordable greeting card-style discharge instruction card

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: University of South Florida
• Investigators: Principal Investigator: John D Cowden, MD,MPH, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Asthma; Health Literacy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 0909209E