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

NCT ID: NCT02735174

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-11-29

Brief 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.

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm asthma self-management

Interventions include:

Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits

Group Type: EXPERIMENTAL

Sensor cap system for inhalers

Intervention Type: DEVICE

All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.

App for SmartPhone

Intervention Type: OTHER

All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.

Motivational interviews

Intervention Type: BEHAVIORAL

All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills

Telehealth clinic visits

Intervention Type: OTHER

All subjects will have asthma medical visits via telehealth technology to assess asthma control.

Interventions

Sensor cap system for inhalers

All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.

Intervention Type: DEVICE

App for SmartPhone

All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.

Intervention Type: OTHER

Motivational interviews

All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills

Intervention Type: BEHAVIORAL

Telehealth clinic visits

All subjects will have asthma medical visits via telehealth technology to assess asthma control.

Intervention Type: OTHER

Other Intervention Names

Propeller

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Verizon Foundation

OTHER

Sponsor Role: collaborator

Luther Foundation

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Theresa Guilbert, MD

M.D., Professor Division of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa Guilbert, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CIN001_AFS4

Identifier Type: -

Identifier Source: org_study_id