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Preference and effectiveness of symptom-based adjustment of inhaled corticosteroid therapy in African American children
Investigator (PI): Sumino, Kaharu
Performing Organization (PO): (Current): Washington University in St. Louis, School of Medicine, Department of Medicine, Division of Pulmonary and Critical Care Medicine / (314) 454-8917
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: PCORI/AS-1307-05588
Funding: Total Award Amount: $2,297,100
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: African American (AA) children have a higher risk of developing asthma and suffering from increased asthma-related health issues and death. A major cause of the increased rates of asthma and poorer health in AA children is due to a lack of observance to recommended medication use such as daily inhalers called inhaled corticosteroids (ICS). It is recommended that the doctor review the control of asthma with the parents to adjust treatment plans to encourage the use of ICS and to avoid the burden asthma can have on a child's well-being. Unfortunately, visits to the doctor to actively manage the child's asthma often do not occur, especially in high-risk minority populations. Some parents go further to avoid daily medications once their child's asthma is well-controlled and instead heavily rely on rescue medications and the emergency department for care when symptoms become worse. There is a new patient-centered approach to asthma therapy that has been discovered called symptom-based adjustment (SBA). This adjustment method allows the patient to control their medication usage based on their daily symptoms: take their ICS when they need to take the rescue inhaler. Research studies in adult patients with mild to moderate asthma showed that SBA was similarly good in controlling asthma symptoms and preventing asthma attacks compared to the current common approach to asthma therapy called guideline-based physician adjustment (GBA). Additional study in children also has found SBA to be a favorable treatment plan for children with mild asthma. What is unknown is how this treatment plan would work in a real-world application, especially in AA children. The overall goal of this proposal is to identify a practical and effective approach to asthma management in high-risk AA children. The researchers believe that SBA will be a better approach for parents and caregivers in helping manage asthma therapy and will be just as effective as GBA in controlling children's asthma, but with less dose of medicine. This study will be done in two parts. Stage 1 will include a focus group study of caregivers and older children with asthma, interviews with medical doctors in the primary care clinics, and development of an advisory board with community members to help guide the study. Stage 2 will be a clinical trial conducted in community primary care pediatric clinics to see how SBA works compared to GBA in controlling the child's asthma and preventing exacerbation in the real world. The participants will randomly assigned to do GBA or SBA guided by their primary care doctors for 12 months. We will measure the change in asthma control as outcome. If the researchers find that SBA is acceptable to caregivers, physicians, and parents and equally effective to GBA in controlling asthma in AA children, this proposal will result in a fundamental change asthma management and will help improve asthma control in a large minority pediatric population.
MeSH Terms:
  • Adrenal Cortex Hormones /*administration & dosage
  • African Americans
  • Asthma /*drug therapy
  • /*ethnology
  • Caregivers
  • Child
  • Clinical Trials as Topic
  • Community Health Services
  • Focus Groups
  • Guidelines as Topic
  • Humans
  • Inhalation
  • Minority Groups
  • Patient-Centered Care
  • Primary Health Care /organization & administration
  • Risk
  • Symptom Assessment
  • United States
Country: United States
State: Missouri
Zip Code: 63108
UI: 20143422
CTgovId: NCT02298205
Project Status: Completed
Record History: ('2017: Project extended to 2019.',)