Improving Asthma Care by Partnering With School Nurses to Bring Asthma Care Into the Inner-City Schools

Asthma Clinical Trial

— AFS4  

Official title:

Phase 4: Improving Asthma Outcomes By Facilitating Patient-Centered Care At School (Asthma-Free School)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735174
• Other study ID #: CIN001_AFS4
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: November 29, 2018

Study information

• Verified date: September 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to improve the partnership between Cincinnati Children's Medical Center (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to reduce childhood asthma in the inner city schools of Cincinnati and CCHMC. We are calling this project "asthma-free schools" and bringing it to neighborhoods where the incidence of asthma is especially high. We have designed this study to work with school-based asthma care programs. Children with high-risk asthma will be asked to participate. "High-risk" will be defined as poorly controlled asthma, frequent school absences, and/or need for daily controller asthma medications. We will use a commercially available inhaler cap sensor to help track medication use and symptoms through a smartphone. The study visits will be done mostly at the school using telehealth technology similar to Skype.

Description:

This study is part of a community health collaboration between Cincinnati Children's Hospital Medical Center (CCHMC), the local public health department and designated inner city schools. The purpose is to address school-based asthma care barriers and then to test the efficacy of this program in a pilot study to improve asthma outcomes in 30 urban core youth.

Greater Cincinnati's geography places it at the environmentally tricky confluence of low-lying smog-trapping hills, three heavily traveled interstate highways, and high rate of allergen exposure. This makes it an area ripe for asthma. The overall rate of pediatric asthma in Greater Cincinnati is more than twice the national average and, in some urban-core neighborhoods, as high as 10 times the national rate.

Poor asthma control across the nation and locally in Cincinnati is associated with an overrepresentation of children from minority groups, low-income families, and single parent households who deal with economic hardship and familial strain compared to those with well-controlled asthma. Data show that no more than 50% of patients keep appointments or fill prescriptions, leading to continued poor asthma control and risk for future exacerbation.

This is an interventional pilot study where about 30 high-risk asthmatic participants will be identified to participate and a number of interventions will be incorporated including asthma specific questionnaires, use of a commercially available inhaler cap with monitoring sensor, a mobile software management platform that tracks adherence of all asthma medications, mobile based telehealth medical visits to assess asthma control, and mobile based telehealth adherence problem-solving interventions.

This proposal is funded through a Luther Foundation and Verizon Foundation philanthropic gifts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• history of provider diagnosed asthma

• history of uncontrolled asthma in the past 12 months as measured by two asthma control Test (ACT) scores less than 20; or more than or equal to 1 emergency room visit or hospitalization for asthma; or more than or equal to 2 prednisone bursts with current persistent asthma as defined by National Asthma Education and Prevention Program (NAEPP) guidelines

• attendance at participating school

Exclusion Criteria:

• active chronic disease apart from asthma or allergic disease

• plans to change schools during the school year

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Sensor cap system for inhalers
All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.

Other:
• App for SmartPhone
All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.

Behavioral:
• Motivational interviews
All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills

Other:
• Telehealth clinic visits
All subjects will have asthma medical visits via telehealth technology to assess asthma control.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Luther Foundation, Verizon Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Composite Asthma Severity Index (CASI) Score	Change in composite asthma severity index score (Baseline CASI score-6 month CASI score). A positive score indicates a better outcome.; [The CASI score has a minimum value = 0, maximum value = 20]. The rows represent the change from baseline in scores in all subjects and subsets of participants who obtained "CASI >=4 at baseline and "CASI <4" at baseline.	Baseline to 6 months