Talking Card for Asthma

NCT ID: NCT02041013

Last Updated: 2015-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-10-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Taking Card

Usual care, as in comparison group, plus recordable Talking Card at each visit

Group Type: EXPERIMENTAL

Taking Card

Intervention Type: OTHER

Recordable greeting card-style discharge instruction card

Interventions

Taking Card

Recordable greeting card-style discharge instruction card

Intervention Type: OTHER

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

John D Cowden

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John D Cowden, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

University of South Florida

Tampa, Florida, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

0909209E

Identifier Type: -

Identifier Source: org_study_id