Asthma Action at Erie Trial
2 other identifiers
interventional
223
1 country
1
Brief Summary
The Asthma Action at Erie Trial compares the current best practice in asthma self-management education (certified asthma educator services) to an integrated community health worker (CHW) home intervention in which the real-life challenges of patients and the health care system are taken fully into account. This trial will provide clarity as to the expected effect size, cost savings, and resources needed to integrate asthma CHWs into clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Apr 2015
Longer than P75 for phase_3 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
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
December 9, 2021
CompletedDecember 9, 2021
November 1, 2021
5 years
June 5, 2015
July 22, 2021
November 11, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Asthma Control Test/Childhood Asthma Control Test at 12-months
Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control
assessed 12-months from baseline, assessed over past 4 weeks
Activity Limitation at 12-months
Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control
assessed 12-months after baseline, assessed over past 14 days
Secondary Outcomes (3)
Asthma Control Questionnaire at 12-months
assessed 12-months after baseline, prior week assessed
Health Care Utilization at 12-months
assessed 12-months after baseline, assessed from baseline to 12-months
Costs of Intervention Delivery
assessed 12-months from baseline, assessed from baseline to 12-months
Study Arms (2)
Community health worker
EXPERIMENTALParticipants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support.
Certified asthma educator
ACTIVE COMPARATORParticipants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions.
Interventions
A community health worker is para-professional who performs education, case management, and social support.
A certified asthma educator has is certified and performs asthma education.
Eligibility Criteria
You may qualify if:
- Child is a patient at Erie Family Health Center
- Child is age 5-16 at the start of the study
- Child lives with the index caregiver at least 5 days out of the week
- Child has uncontrolled asthma. This is defined as a score of 1.25 or greater on the Asthma Control Questionnaire, or report of oral corticosteroid use in the past year
- Family has a working telephone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- Erie Family Health Centercollaborator
- Rush University Medical Centercollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Erie Family Health Center
Chicago, Illinois, 60622, United States
Related Publications (4)
Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
PMID: 39382077DERIVEDWeinstein SM, Pugach O, Rosales G, Mosnaim GS, Orozco K, Pappalardo AA, Martin MA. Psychosocial Moderators and Outcomes of a Randomized Effectiveness Trial for Child Asthma. J Pediatr Psychol. 2021 Jul 20;46(6):673-687. doi: 10.1093/jpepsy/jsab011.
PMID: 33616185DERIVEDWeinstein SM, Pugach O, Rosales G, Mosnaim GS, Walton SM, Martin MA. Family Chaos and Asthma Control. Pediatrics. 2019 Aug;144(2):e20182758. doi: 10.1542/peds.2018-2758. Epub 2019 Jul 9.
PMID: 31289192DERIVEDMosnaim GS, Weinstein SM, Pugach O, Rosales G, Roy A, Walton S, Martin MA. Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial. Contemp Clin Trials. 2019 Apr;79:55-65. doi: 10.1016/j.cct.2019.02.006. Epub 2019 Feb 14.
PMID: 30772471DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Molly A Martin, MD
- Organization
- University of Illinois Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 5, 2015
First Posted
June 25, 2015
Study Start
April 1, 2015
Primary Completion
March 31, 2020
Study Completion
March 31, 2021
Last Updated
December 9, 2021
Results First Posted
December 9, 2021
Record last verified: 2021-11