Childhood AsthmaWPCANCT03514485
West Philadelphia Controls Asthma
A study testing Yes We Can Children's Asthma Program, School-Based Asthma Therapy and Open Airways for School Plus in people with Childhood Asthma and Community Health Workers, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Childhood Asthma, Community Health Workers
- What is being tested?
- Yes We Can Children's Asthma Program, School-Based Asthma Therapy and Open Airways for School Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 30 Jun 2022
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 5-13 years of age and their parents/guardians
- Children with a diagnosis of asthma
- Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an Emergency Department (ED) visit for asthma -OR- an inpatient admission for asthma)
- West Philadelphia residence in zip code 19104, 19131, 19139, 19142, 19143, 19151 or 19153
- Children in grades K-8
- Pediatric primary care received at Children's Hospital of Philadelphia Care Network (CN) Karabots, Cobbs Creek, or South Philadelphia locations or pediatric care received at the Pediatric and Adolescent Medicine Centers of Philadelphia (PAMCOP) serving West Philadelphia residents
- Parental/guardian permission (informed consent) and, if appropriate, child assent
- English Language Speaking
Who cannot join
- Subjects with other chronic respiratory illnesses such as cystic fibrosis
- Cyanotic congenital heart disease
- Mental retardation and/or cerebral palsy (MRCP)
- Severe Neurological Disorder
- Cyanotic congenital heart disease
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
Official title: West Philadelphia Asthma Care Implementation Plan
This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. The objective is to integrate the home, school, healthcare system, and community for 600 school-aged asthmatic children in West Philadelphia through use of CHWs.
The children enrolled in the study will be randomized to one of four groups including: primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).
Read the detailed description
The Community Asthma Prevention Program (CAPP) at the Children's Hospital of Philadelphia has a two-decade history of utilizing CHWs to improve asthma outcomes of children in Philadelphia. Building on this foundation, a network of stakeholders was established including, The West Philadelphia Asthma Care Collaborative (WEPACC), with representation from public housing, healthcare, community, and schools. As a result of assessment of local needs, resource mapping, and months of planning, Investigators designed an asthma care implementation program with the broad objective of integrating home, school, healthcare system, and community for school-aged asthmatic children in West Philadelphia. Investigators seek to accomplish this goal using CHWs to deliver sustainable patient-centered evidence-based interventions. The evidence-based interventions include (1) a primary care-based Yes We Can intervention with home visitation and (2) a comprehensive and rigorously evaluated school-based intervention, Open Airways for schools and School Based Asthma Therapy. CHWs will function as the hub of each interventions, serving either as primary care CHWs or school CHWs to provide a network of education, care coordination support, and to facilitate communication for families of children with asthma between the four sectors. This project seeks to integrate interventions in a comprehensive and sustainable manner to reduce asthma disparities in poor, minority children.
Using a factorial design, Investigators will recruit and randomize 640 asthmatic children (ages 5-13 years) from up to five inner-city primary care clinics who attend one of 36 West Philadelphia schools to one of four study conditions: both interventions (both primary care and school CHWs intervention), primary care CHW or school-CHW alone, or control and follow for one year. As a part of this project the Investigators seek to accomplish the following objectives:
Objective 1. Compare effectiveness of the primary care and school interventions to improve asthma control and reduce symptom days using main and simple effects from the factorial design.
Objective 2. Explore moderators and mechanisms of effectiveness and sustainability of the interventions.
Objective 3. Use mixed methods to explore implementation determinants and outcomes of school intervention that promote effectiveness, fidelity and sustainability
Objective 4. Examine the costs, savings, and cost effectiveness associated with the intervention and implementation strategies to promote sustainability.
- Conditions
- Childhood Asthma, Community Health Workers
- Being tested
- Yes We Can Children's Asthma Program, School-Based Asthma Therapy, Open Airways for School Plus
- Keywords
- asthma disparities, community health worker, childhood asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yes We Can Children's Asthma ProgramBehavioural
Also called Primary Care Intervention
The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.
School-Based Asthma TherapyBehavioural
Also called Primary Care and School Intervention (Partner School)
School-Based Asthma Therapy includes enhanced care coordination for prescribed daily controller medication. The school nurse will coordinate with teachers and the school CHW to schedule daily controller asthma medication administration. The school CHW will assist in obtaining a current asthma care plan and medication administration form from the primary care provider.
Open Airways for School PlusBehavioural
Also called School Intervention (Partner School)
Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:
- Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester.
- Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
- Asthma education for school staff/personnel at the start of each school year.
- School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.
| Study group | Role | What they receive |
|---|---|---|
| P+S- (Partner School) | Active comparator | This arm includes children who attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program. Receives: Behavioral: Yes We Can Children's Asthma Program |
| P-S+ (Partner School) | Active comparator | This arm includes children who attend one of the partnering schools and who are randomized to receive the school intervention Open Airways for Schools Plus. Receives: Behavioral: Open Airways for School Plus |
| P+S+ (Partner School) | Active comparator | This arm includes children who attend one of the partnering schools and who are randomized to receive the enhanced school intervention Open Airways for Schools Plus, School-Based Asthma Therapy and the primary care intervention Yes We Can Children's Asthma Program. Receives: Behavioral: Yes We Can Children's Asthma Program; Behavioral: School-Based Asthma Therapy; Behavioral: Open Airways for School Plus |
| P-S- (Partner School) | No intervention | This arm includes children who attend one of the partnering schools, and are randomized to the control group (no primary care or school intervention). |
| P+ (Non-Partner School) | Active comparator | This arm includes children who do not attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program. Receives: Behavioral: Yes We Can Children's Asthma Program |
| P- (Non-Partner School) | No intervention | This arm includes children who do not attend one of the partnering schools and who are randomized to the control group (no primary care intervention and ineligible for the school intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Asthma Control
Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week. The 6-item recall includes awakening at night with asthma symptoms, asthma symptoms upon waking, activity limitations due to asthma symptoms, shortness of breath, wheezing, and administration of asthma rescue medications. The score range for the ACQ is 0 to 6, with lower numbers indicating greater asthma control and higher numbers indicating worse asthma control. Based on existing literature, the minimal clinically important difference (MCID) is 0.5. The range for this cohort is 0.2-2.3) For all analyses, we combined the P+S- group with the P+S0 group to describe the P+ only group. Similarly, we combined the P-S- group with the P-S0 group to create the control group.
Measured: Baseline and 12 months
Secondary outcomes (10)
Change in Daytime Asthma Symptoms
Comparison of the change in daytime symptoms from baseline to 12 months for each intervention group. This data was collected at 3 month intervals with a 2 week recall for number of days with symptoms. This question asks how many days the child has had daytime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days).
P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Measured: Baseline and 12 months
Change in Nighttime Symptoms
Comparison of the change in nighttime symptoms from baseline to 12 months for each intervention group. This question asks how many days the child has had nighttime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days).
P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Measured: Baseline and 12 months
Change in School Absences
School report of child's school absences pre and post study enrollment
Measured: Baseline and 12 months
Change in Emergency Department (ED) Visits
Comparison of the change in asthma-related Emergency Department visits from baseline to 12 months for each intervention group
Measured: Baseline and 12 months
Change in Hospitalizations
Comparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group
Measured: Baseline and 12 months
Change in Asthma Emotional Functioning Domain
Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group.
Data was collected using Juniper's Pediatric Asthma Caregiver's Quality of Life Questionnaire designed for children aged 7 to 17 years of age. The PAQLQ has 23 questions in 3 domains, including emotional function. The questions ask about a 1 week recall.
The range for answer choices is 1-7, with the higher number indicating a better quality of life. The score for the subscale is the mean of the answers for that subscale.
Measured: Baseline and 12 months
Change in Activity Limitations Domain
Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group.
he Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) by Juniper et al. is a 13-item measure of asthma caregiver's quality of life in two domains, including activity limitation.
The score for the subscale is the mean of the answers for the subscale. All items are weighted equally and the score range is 1 - 7, with lower numbers indicating poor quality of life and higher numbers indicating better quality of life around caring for a child with asthma.
Measured: Baseline and 12 months
Baseline School Organizational Climate Index
The Standardized Organizational Climate Index (SOCI) is a 30-item descriptive measure for schools. The index has four dimensions: principal leadership, teacher professionalism, achievement press for students to perform academically, and vulnerability to the community. The score range for each questionnaire item is 1 - 4. The answers assign the value of 1 to "rarely occurs," 2 to "sometimes occurs," 3 to "often occurs," and 4 to "very frequently occurs. For the subscores, ninety-nine percent of the scores range from 200 to 800 with a population mean of 500 and a population standard deviation of 100. Higher scores indicate a better school climate. Scores are converted to standardized scores and compared with national norms.
Measured: At start of school intervention
Baseline School Leadership
The Implementation Leadership Scale (ILS) is comprised of 12 items assessing the degree to which a leader is Proactive, Knowledgeable, Supportive, and shows Perseverance in implementing evidence-based practice. The range for total score and each subscale score is 0 - 4. Higher scores represent better implementation leadership. The mean of the subscale scores yields the total score.
Measured: At start of school intervention
Baseline School Staff Attitudes
The Evidence-Based Practice Attitude Scale (EBPAS) is a 15-item self-report measure of attitudes toward adoption of EBPs. It consists of four subscales: Appeal (is EBP intuitively appealing), Requirements (would an EBP be used if required), Openness (general openness to innovation), and Divergence (perceived divergence between EBP and current practice). Total score range is 0 - 60. The Appeal, Openness, and Divergence subscales have a range of 0 - 16. The Requirements subscale has a range of 0 - 12. Higher scores indicate more positive attitudes. Subscales are summed to compute a total score.
Measured: At start of school intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start17 May 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Childhood AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Factorial
- Model description
- A factorial design has enhanced statistical power and can handle cluster randomization of schools. Statistical methods will be used to estimate variation in the effect across schools over time. Linear mixed effects models with random intercepts and slopes for school, and fixed effects for the school-level intervention, time, and time-by-intervention interaction will be applied. Second, marginal models using generalized estimating equations will produce robust estimates that adjust for clustering at the school level. Third, assumption-free, randomization-test-based methods do not rely on assumptions of parametric models. Investigators will use conventional levels of statistical significance (p=0.05) for all pre-specified comparisons for our objectives. Variability of the intervention effect across schools will reflect consistency of intervention effects and thus generalizability in new settings. Both mixed effects models and permutation-test methods will estimate variance components.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Education-Plus, Inc., The School District of Philadelphia, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Tyra Bryant-Stephens, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514485
- Sponsor's protocol ID
- 17-013892
- Other IDs
- 1U01HL138687-01
- Acronym
- WPCA
- Status last verified
- Oct 2024
- First submitted
- 26 Jun 2017
- Last updated
- 30 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators do not plan to share individual level participant data with other researchers, however Investigators plan to make the results (de-identified, aggregate data) available to other researchers and stakeholders interested in asthma and the reduction of asthma disparities. Investigators plan to share results during presentations at organizational and scientific meetings, annual Asthma Summit and published manuscripts. The results will also be shared with the PubMed Data Library.
Publications
Bryant-Stephens T, Kenyon CC, Tingey C, Apter A, Pappas J, Minto N, Stewart YS, Shults J. Community Health Workers Linking Clinics and Schools and Asthma Control: A Randomized Clinical Trial. JAMA Pediatr. 2024 Dec 1;178(12):1260-1269. doi: 10.1001/jamapediatrics.2024.3967.
PubMed 39432292
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- West Philadelphia Asthma Care Implementation Plan
- ClinicalTrials.gov ID
- NCT03514485
- Acronym / sponsor ID
- WPCA / 17-013892
- Conditions
- Childhood Asthma, Community Health Workers
- Keywords
- asthma disparities, community health worker, childhood asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Education-Plus, Inc., The School District of Philadelphia, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Posted 30 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. The objective is to integrate the home, school, healthcare system, and community for 600 school-aged asthmatic children in West Philadelphia through use of CHWs.
The children enrolled in the study will be randomized to one of four groups including: primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).
Detailed description
The Community Asthma Prevention Program (CAPP) at the Children's Hospital of Philadelphia has a two-decade history of utilizing CHWs to improve asthma outcomes of children in Philadelphia. Building on this foundation, a network of stakeholders was established including, The West Philadelphia Asthma Care Collaborative (WEPACC), with representation from public housing, healthcare, community, and schools. As a result of assessment of local needs, resource mapping, and months of planning, Investigators designed an asthma care implementation program with the broad objective of integrating home, school, healthcare system, and community for school-aged asthmatic children in West Philadelphia. Investigators seek to accomplish this goal using CHWs to deliver sustainable patient-centered evidence-based interventions. The evidence-based interventions include (1) a primary care-based Yes We Can intervention with home visitation and (2) a comprehensive and rigorously evaluated school-based intervention, Open Airways for schools and School Based Asthma Therapy. CHWs will function as the hub of each interventions, serving either as primary care CHWs or school CHWs to provide a network of education, care coordination support, and to facilitate communication for families of children with asthma between the four sectors. This project seeks to integrate interventions in a comprehensive and sustainable manner to reduce asthma disparities in poor, minority children.
Using a factorial design, Investigators will recruit and randomize 640 asthmatic children (ages 5-13 years) from up to five inner-city primary care clinics who attend one of 36 West Philadelphia schools to one of four study conditions: both interventions (both primary care and school CHWs intervention), primary care CHW or school-CHW alone, or control and follow for one year. As a part of this project the Investigators seek to accomplish the following objectives:
Objective 1. Compare effectiveness of the primary care and school interventions to improve asthma control and reduce symptom days using main and simple effects from the factorial design.
Objective 2. Explore moderators and mechanisms of effectiveness and sustainability of the interventions.
Objective 3. Use mixed methods to explore implementation determinants and outcomes of school intervention that promote effectiveness, fidelity and sustainability
Objective 4. Examine the costs, savings, and cost effectiveness associated with the intervention and implementation strategies to promote sustainability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 6
- Model description
- A factorial design has enhanced statistical power and can handle cluster randomization of schools. Statistical methods will be used to estimate variation in the effect across schools over time. Linear mixed effects models with random intercepts and slopes for school, and fixed effects for the school-level intervention, time, and time-by-intervention interaction will be applied. Second, marginal models using generalized estimating equations will produce robust estimates that adjust for clustering at the school level. Third, assumption-free, randomization-test-based methods do not rely on assumptions of parametric models. Investigators will use conventional levels of statistical significance (p=0.05) for all pre-specified comparisons for our objectives. Variability of the intervention effect across schools will reflect consistency of intervention effects and thus generalizability in new settings. Both mixed effects models and permutation-test methods will estimate variance components.
| Arm | Type | Receives |
|---|---|---|
| P+S- (Partner School) | Active comparator | Behavioral: Yes We Can Children's Asthma ProgramThis arm includes children who attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program. |
| P-S+ (Partner School) | Active comparator | Behavioral: Open Airways for School PlusThis arm includes children who attend one of the partnering schools and who are randomized to receive the school intervention Open Airways for Schools Plus. |
| P+S+ (Partner School) | Active comparator | Behavioral: Yes We Can Children's Asthma Program, Behavioral: School-Based Asthma Therapy, Behavioral: Open Airways for School PlusThis arm includes children who attend one of the partnering schools and who are randomized to receive the enhanced school intervention Open Airways for Schools Plus, School-Based Asthma Therapy and the primary care intervention Yes We Can Children's Asthma Program. |
| P-S- (Partner School) | No intervention | –This arm includes children who attend one of the partnering schools, and are randomized to the control group (no primary care or school intervention). |
| P+ (Non-Partner School) | Active comparator | Behavioral: Yes We Can Children's Asthma ProgramThis arm includes children who do not attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program. |
| P- (Non-Partner School) | No intervention | –This arm includes children who do not attend one of the partnering schools and who are randomized to the control group (no primary care intervention and ineligible for the school intervention). |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children 5-13 years of age and their parents/guardians
- Children with a diagnosis of asthma
- Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an Emergency Department (ED) visit for asthma -OR- an inpatient admission for asthma)
- West Philadelphia residence in zip code 19104, 19131, 19139, 19142, 19143, 19151 or 19153
- Children in grades K-8
Key exclusion criteria (6 listed)
- Subjects with other chronic respiratory illnesses such as cystic fibrosis
- Cyanotic congenital heart disease
- Mental retardation and/or cerebral palsy (MRCP)
- Severe Neurological Disorder
- Cyanotic congenital heart disease
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 |
|---|---|---|
| Yes We Can Children's Asthma ProgramAlso: Primary Care InterventionThe Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice. | Behavioural | P+ (Non-Partner School), P+S+ (Partner School), P+S- (Partner School) |
| School-Based Asthma TherapyAlso: Primary Care and School Intervention (Partner School)School-Based Asthma Therapy includes enhanced care coordination for prescribed daily controller medication. The school nurse will coordinate with teachers and the school CHW to schedule daily controller asthma medication administration. The school CHW will assist in obtaining a current asthma care plan and medication administration form from the primary care provider. | Behavioural | P+S+ (Partner School) |
| Open Airways for School PlusAlso: School Intervention (Partner School)Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes: 1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester. 2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment. 3. Asthma education for school staff/personnel at the start of each school year. 4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia. | Behavioural | P+S+ (Partner School), P-S+ (Partner School) |
Primary outcome
Change in Asthma Control
Time frame: Baseline and 12 months
Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week. The 6-item recall includes awakening at night with asthma symptoms, asthma symptoms upon waking, activity limitations due to asthma symptoms, shortness of breath, wheezing, and administration of asthma rescue medications. The score range for the ACQ is 0 to 6, with lower numbers indicating greater asthma control and higher numbers indicating worse asthma control. Based on existing literature, the minimal clinically important difference (MCID) is 0.5. The range for this cohort is 0.2-2.3) For all analyses, we combined the P+S- group with the P+S0 group to describe the P+ only group. Similarly, we combined the P-S- group with the P-S0 group to create the control group.
10 secondary outcomes
Change in Daytime Asthma Symptoms
Time frame: Baseline and 12 months
Change in Nighttime Symptoms
Time frame: Baseline and 12 months
Change in School Absences
Time frame: Baseline and 12 months
Change in Emergency Department (ED) Visits
Time frame: Baseline and 12 months
Change in Hospitalizations
Time frame: Baseline and 12 months
Change in Asthma Emotional Functioning Domain
Time frame: Baseline and 12 months
Change in Activity Limitations Domain
Time frame: Baseline and 12 months
Baseline School Organizational Climate Index
Time frame: At start of school intervention
Baseline School Leadership
Time frame: At start of school intervention
Baseline School Staff Attitudes
Time frame: At start of school intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39432292Bryant-Stephens T, Kenyon CC, Tingey C, Apter A, Pappas J, Minto N, Stewart YS, Shults J. Community Health Workers Linking Clinics and Schools and Asthma Control: A Randomized Clinical Trial. JAMA Pediatr. 2024 Dec 1;178(12):1260-1269. doi: 10.1001/jamapediatrics.2024.3967.
- Individual participant dataSharing planned: No. Investigators do not plan to share individual level participant data with other researchers, however Investigators plan to make the results (de-identified, aggregate data) available to other researchers and stakeholders interested in asthma and the reduction of asthma disparities. Investigators plan to share results during presentations at organizational and scientific meetings, annual Asthma Summit and published manuscripts. The results will also be shared with the PubMed Data Library.
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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.
Tyra Bryant-Stephens, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yes We Can Children's Asthma Program, School-Based Asthma Therapy and Open Airways for School Plus in people with Childhood Asthma and Community Health Workers, run by Children's Hospital of Philadelphia 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 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 30 Oct 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2024). 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?
Change in Asthma Control (time frame: Baseline and 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 NCT03514485, 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 30 Oct 2024.