- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00860418
Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)
Pediatric Asthma Alert Intervention for Minority Children
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:
- 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.
- 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 1
Standard asthma education delivered during 2 home visits by a nurse.
|
Standard asthma education during 2 home visits.
Andra namn:
|
Experimentell: 2 PAAL
PAAL
|
Asthma nurse conducts 2 home visits and accompanies the child to primary care provider visit after ED visits
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Number of primary care appointments kept over 12 months
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Number of refills for anti-inflammatory medications prescribed over 12 months
Tidsram: 12 months
|
12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Arlene M Butz, ScD, RN, Johns Hopkins University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Bellin 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.
- Butz 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.
- Butz 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NR010546
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