- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02735174
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)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45229
- Cincinnati Children's Hospital Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Single arm asthma self-management
Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits |
All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.
Altri nomi:
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Composite Asthma Severity Index (CASI) Score
Lasso di tempo: Baseline to 6 months
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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
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Theresa Guilbert, MD, Children's Hospital Medical Center, Cincinnati
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CIN001_AFS4
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .