Clinical Trials Directory

Trials / Completed

CompletedNCT02735174

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Children's Hospital Medical Center, Cincinnati · Academic / Other
Sex
All
Age
10 Years – 17 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICESensor cap system for inhalersAll subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.
OTHERApp for SmartPhoneAll subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.
BEHAVIORALMotivational interviewsAll subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills
OTHERTelehealth clinic visitsAll subjects will have asthma medical visits via telehealth technology to assess asthma control.

Timeline

Start date
2016-01-01
Primary completion
2018-11-29
Completion
2018-11-29
First posted
2016-04-12
Last updated
2020-10-19
Results posted
2020-10-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02735174. Inclusion in this directory is not an endorsement.