AsthmaCHICAGONCT02319967
Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes
A study testing CAPE and CHW home visits in people with Asthma, run by University of Illinois Chicago at 6 sites in United States.
Trial summary
Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- CAPE and CHW home visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2015to Mar 2017
- Phase
- Interventional
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common);
- Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health \& Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital \& Health Sciences System);
- Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);
- Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids);
- Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;
- Diagnosis of asthma exacerbation by treating clinician;
- Treating ED clinician indicates the child is likely to be discharged to home; and
- Caregiver reports that English or Spanish is the preferred language at home.
Who cannot join
- Caregiver declines to provide informed consent, or the child declines to provide assent;
- Child is admitted to an intensive care unit or transferred to another healthcare facility;
- Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;
- Child is enrolled in another study involving a health-related intervention;
- A CHW is already visiting the home as part of another program;
- Child does not reside in Chicago.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sinai Health System
Chicago, Illinois, 60608
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cook County Health & Hospitals System
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
About this study
Official title: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)
Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.
- Conditions
- Asthma
- Being tested
- CAPE, CHW home visits
- Keywords
- community health worker, emergency, asthma
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPEBehavioural
Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
CHW home visitsBehavioural
Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care | No intervention | Inhaler technique education and distribution of spacers to all participants. |
| ED-only | Experimental | Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Receives: Behavioral: CAPE |
| ED-plus-home | Experimental | Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.
Home visits by a community health worker (CHW). Receives: Behavioral: CAPE; Behavioral: CHW home visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Asthma Impact Scale (v1.0, SF8a)
Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma.
PROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is [-44.7 to 44.7]
PROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is [-48 to 48]
The reported value represents a change in T-score from baseline to 6 months after index ED discharge.
A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)
Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers.
PROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is [-35.1 to 35.1]
The reported value represents a change in T-score from baseline to 6 months after index ED discharge.
A negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
Secondary outcomes (15)
Childhood Asthma Control Test (cACT)
The scores of each item were summed for a total score (0-27) to measure change from index to 6-month primary endpoint. Low scores indicate worse asthma; high scores indicate better asthma.
Childhood Asthma Control Test (cACT): Min possible score: 0; Max possible score: 27 Possible range for change in score is [-27 to 27]
The reported value represents a change in score from baseline to 6 months after index ED discharge.
A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
PROMIS Anxiety (v1.0, SF4a)
Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less anxiety; high scores indicate more anxiety.
PROMIS Anxiety: Min possible T-score: 40.3; Max possible T-score: 81.6 Possible range for change in T-score is [-41.3 to 41.3]
The reported value represents a change in T-score from baseline to 6 months after index ED discharge.
A negative change in score indicates improvement in anxiety. A positive change in score indicates worsening of anxiety. A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
PROMIS Depression (v1.0, SF4a)
Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less depression; high scores indicate more depression.
PROMIS Depression: Min possible T-score: 41.0; Max possible T-score: 79.4 Possible range for change in T-score is [-38.4 to 38.4]
The reported value represents a change in T-score from baseline to 6 months after index ED discharge.
A negative change in score indicates improvement in depression. A positive change in score indicates worsening of depression. A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
PROMIS Fatigue (v1.0, SF4a)
Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less fatigue; high scores indicate more fatigue.
PROMIS Fatigue: Min possible T-score: 33.7; Max possible T-score: 75.8 Possible range for change in T-score is [-42.1 to 42.1]
The reported value represents a change in T-score from baseline to 6 months after index ED discharge.
A negative change in score indicates improvement in fatigue (i.e., less fatigue). A positive change in score indicates worsening of fatigue (i.e., more fatigue). A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
PROMIS Sleep Disturbance (v1.0, SF4a)
Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less sleep disturbance; high scores indicate more sleep disturbance.
PROMIS Sleep Disturbance (v1.0, SF4a): Min possible T-score: 32.0; Max possible T-score: 73.3 Possible range for change in T-score is [-41.3 to 41.3]
The reported value represents a change in T-score from baseline to 6 months after index ED discharge.
A negative change in score indicates improvement in sleep disturbance (i.e., less sleep disturbance). A positive change in score indicates worsening of sleep disturbance (i.e., more sleep disturbance). A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
The overall score is the mean score across all 13 items. Each item is scored on a 7-point Likert scale with 1 indicating severe impairment and 7 indicating no impairment. Higher scores indicate better quality of life; lower scores indicate worse quality of life.
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ): Min possible score: 1; Max possible score: 7 Possible range for change in score is [-6 to 6]
The reported value represents a change in overall score from baseline to 6 months after index ED discharge.
A negative change in score indicates worsening quality of life. A positive change in score indicates improvement in quality of life. A score of 0 indicates no change.
Measured: Baseline and 6 months after index ED discharge
Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits
Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months
Measured: 6 months post index ED discharge
Number of Participants With All-cause Hospitalizations
Count of participants (children) with at least one all-cause hospitalization at 6 months
Measured: 6 months post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids
Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge
Measured: 7 days post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller
Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge
Measured: 7 days post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider
Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge
Measured: 4 weeks post index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids
Count of participants who were provided documented discharge instructions to use systemic corticosteroids
Measured: At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller
Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller
Measured: At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication
Count of participants who were provided documented discharge instructions to use an inhaled rescue medication
Measured: At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff
Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge
Measured: At index ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2017
- Study completionMar 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Sinai Health System, Cook County Health & Hospitals System, Rush University Medical Center, Ann & Robert H Lurie Children's Hospital of Chicago, University of Chicago, Chicago Department of Public Health, Respiratory Health Association, Chicago Asthma Consortium, Illinois Institute of Technology, Illinois Emergency Department Asthma Surveillance Project, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jerry Krishnan, University of Illinois Chicago
- Investigators
- Jerry A Krishnan, MD, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319967
- Sponsor's protocol ID
- 2014-1214
- Other IDs
- AS-1307-05420
- Acronym
- CHICAGO
- Status last verified
- Jun 2019
- First submitted
- 15 Dec 2014
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krishnan JA, Martin MA, Lohff C, Mosnaim GS, Margellos-Anast H, DeLisa JA, McMahon K, Erwin K, Zun LS, Berbaum ML, McDermott M, Bracken NE, Kumar R, Margaret Paik S, Nyenhuis SM, Ignoffo S, Press VG, Pittsenbarger ZE, Thompson TM; CHICAGO Plan consortium. Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan. Contemp Clin Trials. 2017 Jun;57:10-22. doi: 10.1016/j.cct.2017.03.015. Epub 2017 Mar 31.
PubMed 28366780
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)
- ClinicalTrials.gov ID
- NCT02319967
- Acronym / sponsor ID
- CHICAGO / 2014-1214
- Conditions
- Asthma
- Keywords
- community health worker, emergency, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Sinai Health System, Cook County Health & Hospitals System, Rush University Medical Center, Ann & Robert H Lurie Children's Hospital of Chicago, University of Chicago, Chicago Department of Public Health, Respiratory Health Association, Chicago Asthma Consortium, Illinois Institute of Technology, Illinois Emergency Department Asthma Surveillance Project, Patient-Centered Outcomes Research Institute
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Posted 22 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care | No intervention | –Inhaler technique education and distribution of spacers to all participants. |
| ED-only | Experimental | Behavioral: CAPEInhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. |
| ED-plus-home | Experimental | Behavioral: CAPE, Behavioral: CHW home visitsInhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Home visits by a community health worker (CHW). |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common);
- Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health \& Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital \& Health Sciences System);
- Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);
- Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids);
- Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;
Key exclusion criteria (6 listed)
- Caregiver declines to provide informed consent, or the child declines to provide assent;
- Child is admitted to an intensive care unit or transferred to another healthcare facility;
- Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;
- Child is enrolled in another study involving a health-related intervention;
- A CHW is already visiting the home as part of another 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 |
|---|---|---|
| CAPEDecision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers | Behavioural | ED-only, ED-plus-home |
| CHW home visitsHome visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies. | Behavioural | ED-plus-home |
Primary outcome
PROMIS Asthma Impact Scale (v1.0, SF8a)
Time frame: Baseline and 6 months after index ED discharge
Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma. PROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is [-44.7 to 44.7] PROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is [-48 to 48] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.
PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)
Time frame: Baseline and 6 months after index ED discharge
Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers. PROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is [-35.1 to 35.1] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change.
15 secondary outcomes
Childhood Asthma Control Test (cACT)
Time frame: Baseline and 6 months after index ED discharge
PROMIS Anxiety (v1.0, SF4a)
Time frame: Baseline and 6 months after index ED discharge
PROMIS Depression (v1.0, SF4a)
Time frame: Baseline and 6 months after index ED discharge
PROMIS Fatigue (v1.0, SF4a)
Time frame: Baseline and 6 months after index ED discharge
PROMIS Sleep Disturbance (v1.0, SF4a)
Time frame: Baseline and 6 months after index ED discharge
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Time frame: Baseline and 6 months after index ED discharge
Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits
Time frame: 6 months post index ED discharge
Number of Participants With All-cause Hospitalizations
Time frame: 6 months post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids
Time frame: 7 days post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller
Time frame: 7 days post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider
Time frame: 4 weeks post index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids
Time frame: At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller
Time frame: At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication
Time frame: At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff
Time frame: At index ED discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28366780Krishnan JA, Martin MA, Lohff C, Mosnaim GS, Margellos-Anast H, DeLisa JA, McMahon K, Erwin K, Zun LS, Berbaum ML, McDermott M, Bracken NE, Kumar R, Margaret Paik S, Nyenhuis SM, Ignoffo S, Press VG, Pittsenbarger ZE, Thompson TM; CHICAGO Plan consortium. Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan. Contemp Clin Trials. 2017 Jun;57:10-22. doi: 10.1016/j.cct.2017.03.015. Epub 2017 Mar 31.
- Patient-Centered Outcomes Research Institute (PCORI): Funding award detailsLink provided by the sponsor.
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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.
Jerry A Krishnan, MD, PhD principal investigator
University of Illinois Chicago
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPE and CHW home visits in people with Asthma, run by University of Illinois Chicago at 6 sites 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 8 inclusion and 6 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2019). 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?
PROMIS Asthma Impact Scale (v1.0, SF8a) (time frame: Baseline and 6 months after index ED discharge). 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 NCT02319967, which also lists 1 linked publication.
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 19 Jun 2019.