Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT02735174
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.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.
Other names: Propeller
All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.
All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills
All subjects will have asthma medical visits via telehealth technology to assess asthma control.
Time frame: Baseline to 6 months
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.
Children's Hospital Medical Center, Cincinnati
Other
Phase 4: Improving Asthma Outcomes By Facilitating Patient-Centered Care At School (Asthma-Free School)
Acronym: AFS4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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