Improving Asthma Care by Partnering With School Nurses to Bring Asthma Care Into the Inner-City Schools (AFS4)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Sensor cap system for inhalers; Other: App for SmartPhone; Behavioral: Motivational interviews; Other: Telehealth clinic visits

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm asthma self-management; Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits

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 Names: Propeller; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Verizon Foundation; Luther Foundation
• Investigators: Principal Investigator: Theresa Guilbert, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Telehealth; Community health; Sensor cap; School based care; AsthmaTreatSmart Application
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CIN001_AFS4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO