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临床试验/NCT02041013
NCT02041013已完成不适用

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

Children's Mercy Hospital Kansas City4 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
4
主要终点
Asthma Control (C-ACT)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Asthma Control (C-ACT)

时间窗: 3 months

Childhood Asthma Control Test (C-ACT) score, measured repeatedly across 3 visits

次要结局

  • Parental Card Use and Satisfaction(3 months)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

John D Cowden

Associate Professor of Pediatrics

Children's Mercy Hospital Kansas City

研究点 (4)

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