West Philadelphia Controls Asthma

NCT03514485 | Completed Results DMC

• 2 other identifiers: 17-0138921U01HL138687-01
• Study Type: interventional
• Target: 626
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Childhood Asthma; Community Health Workers

Keywords

asthma disparities; community health worker; childhood asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 months

Secondary Outcomes (10)

• Change in Daytime Asthma Symptoms

  Baseline and 12 months

• Change in Nighttime Symptoms

  Baseline and 12 months

• Change in School Absences

  Baseline and 12 months

• Change in Emergency Department (ED) Visits

  Baseline and 12 months

• Change in Hospitalizations

  Baseline and 12 months

Study Arms (6)

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.

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.

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.

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.

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).

Interventions

Yes We Can Children's Asthma Program BEHAVIORAL

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.

Also known as: Primary Care Intervention

P+ (Non-Partner School); P+S+ (Partner School); P+S- (Partner School)

School-Based Asthma Therapy BEHAVIORAL

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.

Also known as: Primary Care and School Intervention (Partner School)

P+S+ (Partner School)

Open Airways for School Plus BEHAVIORAL

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.

Also known as: School Intervention (Partner School)

P+S+ (Partner School); P-S+ (Partner School)

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• Education-Plus, Inc.: collaborator
• The School District of Philadelphia: collaborator
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• 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.

  PMID: 39432292 DERIVED

MeSH Terms

Interventions

Primary Health Care; Schools

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration; Non-Medical Public and Private Facilities

Limitations and Caveats

This study was conducted during the pandemic. For this reason, the school intervention was disrupted as schools were closed down completely for six months and then only virtual for three months. This prevented us from conducting the school intervention as per protocol for most of the children in the study. This impacted our outcomes.

Results Point of Contact

• Title: Tyra Bryant-Stephens, MD
• Organization: Children's Hospital of Philadelphia

stephenst@chop.edu

215-590-5261

Study Officials

• Tyra Bryant-Stephens, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Principal Investigator (PI) will be masked to the participant-level intervention group. Unmasking will occur if there is an adverse event that warrants investigation or if the Data Safety and Monitoring Board (DSMB) instructs the PI to become unmasked.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: May 2, 2018
• Study Start: May 17, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 30, 2024
• Results First Posted: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)