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AsthmaPhase 2PAALNCT00860418

Pediatric Asthma Alert Intervention for Minority Children With Asthma

A Phase 2 study testing Pediatric Asthma Alert (PAAL) and Standard asthma education in people with Asthma, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Asthma
What is being tested?
Pediatric Asthma Alert (PAAL) and Standard asthma education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteUnited States
Study dates
Sep 2008to Jun 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 10Show fewer
  • > 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: 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:

  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.
Read the detailed description

Asthma is the number one cause of pediatric emergency department (ED) visits in young children and results in a significant economic impact on society and use of health resources. Reliance on the ED for asthma care is not only costly but it is also a dangerous index of poorly controlled asthma. Recent updated national asthma guidelines recommend daily inhaled corticosteroids (ICS) as the cornerstone of treatment for patients with persistent asthma. When properly used ICS prevent exacerbations, ED visits and hospitalizations and maintain asthma control. However, > 50% of inner city minority children with asthma do not receive or use recommended anti-inflammatory preventive medications. In fact, many children encounter repeated ED visits with no provision of appropriate preventive medications or other components of guideline-based preventive care because of inconsistent follow-up with their primary care provider (PCP). The overall goal of this study is to evaluate whether a standardized caregiver and physician prompting intervention, Pediatric Asthma Alert Leader (PAAL), can improve guideline-based preventive asthma care including increased anti-inflammatory use and preventive PCP visits in children with frequent ED visits. This study builds on the experience with our parent-child-PCP communication intervention ("Improving Asthma Communication in Minority Families", ACE) in which we found that teaching parent and child asthma communication skills resulted in increased anti-inflammatory medication use at 6 months for children with persistent asthma. However, the beneficial effects of this intervention were seen primarily when caregivers and children were reminded by the nurse interventionist to relay specific health information to the PCP. Furthermore, the intervention was not associated with decreased ED visits or appropriate PCP follow-up to sustain preventive care. The proposed PAAL intervention has the potential to substantially improve care for children at highest risk for asthma morbidity and we propose to establish (1) whether the positive effects of the ACE study can be replicated in a specific group of high-risk children with repeat ED visits; 2) whether the effects of the intervention can be enhanced by incorporating consistent clinician prompting to assure the provision of each component of guideline-based asthma care (ICS use, asthma action plan, and sustaining regular follow-up care to monitor asthma control); and 3)whether families not achieving optimal care will respond to a more intensive tiered intervention. We propose a caregiver and clinician prompting/feedback intervention using a pediatric asthma alert leader (PAAL) nurse to 1) organize and relay critical, individualized child health information from the ED and home setting to the PCP in a feedback letter, 2) ensure child and caregiver attendance at the follow-up visit with the PCP and 3) empower the family and prompt the PCP for guideline-based treatment decisions at the PCP visit. We hypothesize that the PAAL intervention will improve preventive care and reduce morbidity and health care costs for high-risk children with asthma compared to a Standard Asthma Education (SAE) control group.

Conditions
Asthma
Being tested
Pediatric Asthma Alert (PAAL), Standard asthma education
Keywords
asthma, feedback, anti-inflammatory, ED visits
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pediatric Asthma Alert (PAAL)Behavioural

    Also called Pediatric Asthma Alert Leader (Nurse)

    Asthma nurse conducts 2 home visits and accompanies the child to primary care provider visit after ED visits

  • Standard asthma educationBehavioural

    Also called Asthma Education

    Standard asthma education during 2 home visits.

Study groups in NCT00860418
Study groupRoleWhat they receive
1Active comparatorStandard asthma education delivered during 2 home visits by a nurse.
Receives: Behavioral: Standard asthma education
2 PAALExperimentalPAAL
Receives: Behavioral: Pediatric Asthma Alert (PAAL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of primary care appointments kept over 12 months

    Measured: 12 months

Secondary outcomes (1)
  1. Number of refills for anti-inflammatory medications prescribed over 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00860418
Sponsor's protocol ID
NR010546
Acronym
PAAL
Status last verified
Jun 2011
First submitted
11 Mar 2009
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35153205
  • 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.

    PubMed 26036621
  • 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.

    PubMed 24517110
  • 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.

    PubMed 22991952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pediatric Asthma Alert (PAAL) and Standard asthma education in people with Asthma, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of primary care appointments kept over 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00860418, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.

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