Talking Card for Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041013
• Other study ID #: 0909209E
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: August 20, 2015
• Start date: November 2009
• Est. completion date: October 2012

Study information

• Verified date: August 2015
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Taking Card
Recordable greeting card-style discharge instruction card

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control (C-ACT)	Childhood Asthma Control Test (C-ACT) score, measured repeatedly across 3 visits	3 months	No
Secondary	Parental Card Use and Satisfaction	Survey of parental card use and satisfaction with card performance, measured repeatedly across 3 visits	3 months	No