AsthmaPhase 3NCT02481986
Asthma Action at Erie Trial
A Phase 3 study testing Community Health Worker and Certified asthma educator in people with Asthma and Children, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- What is being tested?
- Community Health Worker and Certified asthma educator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 31 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Exclusion criteria include family not fluent in English or Spanish, family lives in temporary housing such as a shelter, caregiver does not have permanent custody of child, or child has significant developmental delays or co-morbidities that would limit their ability to participate in the program.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The Asthma Action at Erie Trial will test the ability of a community health worker (CHW) intervention with three important modifications to achieve asthma control in high-risk children. These modifications are: 1) CHWs will be integrated into both the clinical and the home setting, 2) A system for directly addressing mental health and psychosocial barriers will be provided, and 3) Participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. To test this intervention, a two-arm behavioral randomized controlled trial (N=220) will be conducted in partnership with a federally-qualified health center (FQHC) serving a low income, minority population that is at high-risk for significant asthma morbidity. The intervention arm will receive an integrated CHW home intervention for pediatric asthma education. The comparison arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based AE-C education over 12-months, as demonstrated by asthma control. Specific Aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of CHW and AE-C intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the integrated CHW home asthma intervention relative to clinic-based AE-C education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder.
- Being tested
- Community Health Worker, Certified asthma educator
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerBehavioural
A community health worker is para-professional who performs education, case management, and social support.
Certified asthma educatorBehavioural
A certified asthma educator has is certified and performs asthma education.
| Study group | Role | What they receive |
|---|---|---|
| Community health worker | Experimental | Participants 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. Receives: Behavioral: Community Health Worker |
| Certified asthma educator | Active comparator | Participants 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. Receives: Behavioral: Certified asthma educator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: assessed 12-months after baseline, assessed over past 14 days
Secondary outcomes (3)
Asthma Control Questionnaire at 12-months
Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control
Measured: assessed 12-months after baseline, prior week assessed
Health Care Utilization at 12-months
Any ED visits or hospitalizations for asthma (each ED visit or hospitalization is a single event, ED visits that transition into hospitalizations are coded as one event)
Measured: assessed 12-months after baseline, assessed from baseline to 12-months
Costs of Intervention Delivery
This measure is the total dollars spent to deliver the intervention by arm. Costs include CHW and AE-C salaries, supervision, training costs, and intervention materials that resulted in 84 AE-visits and 722 CHW visits.
Measured: assessed 12-months from baseline, assessed from baseline to 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start1 Apr 2015
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Erie Family Health Center, Rush University Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Molly A. Martin, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481986
- Sponsor's protocol ID
- 2015-0026
- Other IDs
- R01HL123797
- Status last verified
- Nov 2021
- First submitted
- 5 Jun 2015
- Last updated
- 9 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 39382077Weinstein 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.
PubMed 33616185Weinstein 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.
PubMed 31289192Mosnaim 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.
PubMed 30772471
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Action at Erie Trial
- ClinicalTrials.gov ID
- NCT02481986
- Acronym / sponsor ID
- 2015-0026
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Erie Family Health Center, Rush University Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 9 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Asthma Action at Erie Trial will test the ability of a community health worker (CHW) intervention with three important modifications to achieve asthma control in high-risk children. These modifications are: 1) CHWs will be integrated into both the clinical and the home setting, 2) A system for directly addressing mental health and psychosocial barriers will be provided, and 3) Participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. To test this intervention, a two-arm behavioral randomized controlled trial (N=220) will be conducted in partnership with a federally-qualified health center (FQHC) serving a low income, minority population that is at high-risk for significant asthma morbidity. The intervention arm will receive an integrated CHW home intervention for pediatric asthma education. The comparison arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based AE-C education over 12-months, as demonstrated by asthma control. Specific Aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of CHW and AE-C intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the integrated CHW home asthma intervention relative to clinic-based AE-C education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community health worker | Experimental | Behavioral: Community Health WorkerParticipants 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 comparator | Behavioral: Certified asthma educatorParticipants 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Exclusion criteria include family not fluent in English or Spanish, family lives in temporary housing such as a shelter, caregiver does not have permanent custody of child, or child has significant developmental delays or co-morbidities that would limit their ability to participate in the program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health WorkerA community health worker is para-professional who performs education, case management, and social support. | Behavioural | Community health worker |
| Certified asthma educatorA certified asthma educator has is certified and performs asthma education. | Behavioural | Certified asthma educator |
Primary outcome
Asthma Control Test/Childhood Asthma Control Test at 12-months
Time frame: assessed 12-months from baseline, assessed over past 4 weeks
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
Activity Limitation at 12-months
Time frame: assessed 12-months after baseline, assessed over past 14 days
Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control
3 secondary outcomes
Asthma Control Questionnaire at 12-months
Time frame: assessed 12-months after baseline, prior week assessed
Health Care Utilization at 12-months
Time frame: assessed 12-months after baseline, assessed from baseline to 12-months
Costs of Intervention Delivery
Time frame: assessed 12-months from baseline, assessed from baseline to 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39382077Lalji 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.
- Derived from this study: PubMed 33616185Weinstein 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.
- Derived from this study: PubMed 31289192Weinstein 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.
- Derived from this study: PubMed 30772471Mosnaim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Community Health Worker and Certified asthma educator in people with Asthma and Children, run by University of Illinois Chicago 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 5 inclusion and 1 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 9 Dec 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Asthma Control Test/Childhood Asthma Control Test at 12-months (time frame: assessed 12-months from baseline, assessed over past 4 weeks). The study lists 2 primary outcomes in all. 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 NCT02481986, 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 9 Dec 2021.