CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Sensor cap system for inhalers +3 moredevice
Likely dose
Not stated in record
Key inclusion· 3
  • Provider-diagnosed asthma
  • Uncontrolled asthma in past 12 months, defined as: ACT score <20 on two occasions, OR ≥1 ER visit/hospitalization for asthma, OR ≥2 prednisone bursts with current persistent asthma per NAEPP guidelines
  • Current attendance at a participating school
Key exclusion· 2
  • Active chronic disease other than asthma or allergic disease
  • Plans to change schools during the school year

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02735174
NCT02735174N/ACompleted

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

Children's Hospital Medical Center, Cincinnati·interventional·Posted Apr 12, 2016·Updated Oct 19, 2020

In Brief

A clinical study evaluating Sensor cap system for inhalers, App for SmartPhone, and 2 other interventions for Asthma. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 12, 2016
Enrollment StartJan 1, 2016
Primary CompletionNov 29, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.2 years ago

Interventions

Sensor cap system for inhalersdevice

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

App for SmartPhoneother

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

Motivational interviewsbehavioral

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

Telehealth clinic visitsother

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