Talking Card for Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Taking Card
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma, Health Literacy
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)
Sites / Locations
- University of South Florida
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Talking Card
Taking Card
Arm Description
Usual care of asthma by study clinician, including evaluation of asthma using C-ACT and clinical history, treatment using asthma action planning
Usual care, as in comparison group, plus recordable Talking Card at each visit
Outcomes
Primary Outcome Measures
Asthma Control (C-ACT)
Childhood Asthma Control Test (C-ACT) score, measured repeatedly across 3 visits
Secondary Outcome Measures
Parental Card Use and Satisfaction
Survey of parental card use and satisfaction with card performance, measured repeatedly across 3 visits
Full Information
NCT ID
NCT02041013
First Posted
January 17, 2014
Last Updated
August 20, 2015
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT02041013
Brief Title
Talking Card for Asthma
Official Title
The Talking Card for Asthma: A Recordable Audio Discharge Instruction Device to Improve Asthma Control
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of South Florida
4. Oversight
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Health Literacy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Talking Card
Arm Type
No Intervention
Arm Description
Usual care of asthma by study clinician, including evaluation of asthma using C-ACT and clinical history, treatment using asthma action planning
Arm Title
Taking Card
Arm Type
Experimental
Arm Description
Usual care, as in comparison group, plus recordable Talking Card at each visit
Intervention Type
Other
Intervention Name(s)
Taking Card
Intervention Description
Recordable greeting card-style discharge instruction card
Primary Outcome Measure Information:
Title
Asthma Control (C-ACT)
Description
Childhood Asthma Control Test (C-ACT) score, measured repeatedly across 3 visits
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Parental Card Use and Satisfaction
Description
Survey of parental card use and satisfaction with card performance, measured repeatedly across 3 visits
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Cowden, MD,MPH
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
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Talking Card for Asthma
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