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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL123797 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Erie Family Health Center | OTHER_GOV |
| Rush University Medical Center | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker | Behavioral | A community health worker is para-professional who performs education, case management, and social support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire at 12-months | Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control | assessed 12-months after baseline, prior week assessed |
| Health Care Utilization at 12-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erie Family Health Center | Chicago | Illinois | 60622 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39382077 | Derived | 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. | |
| 33616185 | Derived | Weinstein 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Community Health Worker | 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. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support. |
| FG001 | Certified Asthma Educator | 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. Certified asthma educator: A certified asthma educator has is certified and performs asthma education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Community Health Worker | 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. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | assessed 12-months from baseline, assessed over past 4 weeks |
|
24 months per participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Community Health Worker | 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. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Molly A Martin, MD | University of Illinois Chicago | 312-996-2363 | mollyma@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2018 | Jul 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Certified asthma educator | Behavioral | A certified asthma educator has is certified and performs asthma education. |
|
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)
| 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. | assessed 12-months from baseline, assessed from baseline to 12-months |
| 31289192 | Derived | Weinstein 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. |
| 30772471 | Derived | Mosnaim 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. |
| BG001 |
| Certified Asthma Educator |
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. Certified asthma educator: A certified asthma educator has is certified and performs asthma education. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | One family did not answer child race. Note that race and ethnicity were asked as separate questions. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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. Certified asthma educator: A certified asthma educator has is certified and performs asthma education. |
|
|
| Primary | Activity Limitation at 12-months | Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control | Posted | Least Squares Mean | 95% Confidence Interval | ratio of days | assessed 12-months after baseline, assessed over past 14 days |
|
|
|
| Secondary | Asthma Control Questionnaire at 12-months | Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | assessed 12-months after baseline, prior week assessed |
|
|
|
| Secondary | 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) | Posted | Least Squares Mean | 95% Confidence Interval | events | assessed 12-months after baseline, assessed from baseline to 12-months |
|
|
|
| Secondary | 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. | Posted | Number | dollars spent per arm on intervention | assessed 12-months from baseline, assessed from baseline to 12-months |
|
|
|
| 0 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | Certified Asthma Educator | 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. Certified asthma educator: A certified asthma educator has is certified and performs asthma education. | 0 | 115 | 0 | 115 | 0 | 115 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |