Pediatric Asthma Alert Intervention for Minority Children With Asthma
PAAL
1 other identifier
interventional
350
1 country
1
Brief Summary
Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough. The investigators hypothesize that:
- 1.Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group.
- 2.Children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Sep 2008
Longer than P75 for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 11, 2009
CompletedFirst Posted
Study publicly available on registry
March 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 2, 2015
June 1, 2011
4.8 years
March 11, 2009
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of primary care appointments kept over 12 months
12 months
Secondary Outcomes (1)
Number of refills for anti-inflammatory medications prescribed over 12 months
12 months
Study Arms (2)
1
ACTIVE COMPARATORStandard asthma education delivered during 2 home visits by a nurse.
2 PAAL
EXPERIMENTALPAAL
Interventions
Asthma nurse conducts 2 home visits and accompanies the child to primary care provider visit after ED visits
Standard asthma education during 2 home visits.
Eligibility Criteria
You may qualify if:
- All 6 criteria must be met:
- Physician-diagnosed asthma (based on caregiver report with validation from the child's physician)
- \> 2 ED visits or \> 1 hospitalization for asthma within past 12 months
- Mild persistent to severe persistent asthma based on NHLBI guidelines criteria (7-9) having any 1 of the following:
- An average of \> 2 days per week of asthma symptoms
- \> 2 days per week with rescue medication use (albuterol, xopenex) OR
- \> 2 days per month of nighttime symptoms
- Age \> 3 and \< 10 years
- Reside in Baltimore Metropolitan area
- Not currently participating in another asthma study or sibling enrolled in PAAL study
You may not qualify if:
- Inability to speak and understand English
- No access to a working phone or alternate phone for follow-up surveys
- Co-morbid respiratory condition including cystic fibrosis, chronic lung disease (BPD), lung cancer, tracheostomy that could interfere with the assessment of asthma-related outcome measures.
- Children residing in foster care or where consent cannot be obtained from a legal guardian.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- University of Marylandcollaborator
- University of Rochestercollaborator
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Related Publications (4)
Bellin MH, Margolis RH, Whitney L, Osteen P, Thompson A, Butz AM. Violence Exposure, Child Asthma Morbidity, and Maternal Depressive Symptoms: A Longitudinal Analysis of Cumulative Risk. J Health Care Poor Underserved. 2022;33(1):47-66. doi: 10.1353/hpu.2022.0006.
PMID: 35153205DERIVEDBellin MH, Osteen P, Kub J, Bollinger ME, Tsoukleris M, Chaikind L, Butz AM. Stress and Quality of Life in Urban Caregivers of Children With Poorly Controlled Asthma: A Longitudinal Analysis. J Pediatr Health Care. 2015 Nov-Dec;29(6):536-46. doi: 10.1016/j.pedhc.2015.04.018. Epub 2015 May 30.
PMID: 26036621DERIVEDButz AM, Halterman J, Bellin M, Kub J, Tsoukleris M, Frick KD, Thompson RE, Land C, Bollinger ME. Improving preventive care in high risk children with asthma: lessons learned. J Asthma. 2014 Jun;51(5):498-507. doi: 10.3109/02770903.2014.892608. Epub 2014 Feb 27.
PMID: 24517110DERIVEDButz AM, Halterman JS, Bellin M, Kub J, Frick KD, Lewis-Land C, Walker J, Donithan M, Tsoukleris M, Bollinger ME. Factors associated with completion of a behavioral intervention for caregivers of urban children with asthma. J Asthma. 2012 Nov;49(9):977-88. doi: 10.3109/02770903.2012.721435. Epub 2012 Sep 19.
PMID: 22991952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arlene M Butz, ScD, RN
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 11, 2009
First Posted
March 12, 2009
Study Start
September 1, 2008
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 2, 2015
Record last verified: 2011-06