- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02205723
Smartphone-facilitated Asthma Control (SNAPP)
Smartphone-facilitated Medication Notification for Asthma Control in Pediatric Patients (SNAPP) Pilot Study
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The objective of this protocol is to pilot an innovative approach to medication adherence to determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence, a critical gap in improving the health of children with asthma.
Acute asthma exacerbations occur yearly in almost 60% of children with asthma. They are the most frequent reason for childhood hospitalization and the most expensive component of pediatric asthma care in the U.S. Exacerbations impair quality of life and disproportionately affect African-American children, children with Medicaid insurance, and the poor. Up to 70% of exacerbations are preventable if guideline-recommended inhaled corticosteroid (ICS) medication adherence is achieved. However, ICS medication adherence in children with persistent asthma is dismal at only 11 - 18%. Amongst children with Medicaid insurance prescribed ICS, 63% discontinue the medication within 90 days. As a healthcare system, investigators have been unable to meaningfully improve ICS medication adherence in a cost-efficient way for patients with asthma, and particularly for the high-risk, highest-potential population of children with moderate or severe persistent asthma. These children suffer the greatest morbidity and mortality from asthma yet have highest-potential to benefit from improved ICS medication adherence. There is an urgent need for an efficacious adherence intervention for this population because, without it, these children will continue to experience impaired health and disproportionate morbidity.
The investigators' long-term objective is to identify and disseminate an intervention that will minimize the occurrence and severity of exacerbations in this population. The overall objective of this pilot study is to test the feasibility of Smartphone-facilitated medication Notification for Asthma Control in Pediatric Patients (SNAPP) using a wireless medication monitor (WMM) and smartphone application that provides parents reminders for administration of ICS medication, real-time feedback on preventive and controller medication adherence, and wireless upload of this data to a secure online database. The central hypothesis is that for children in this population, SNAPP will result in >=25% improved Asthma Control Test (ACT) scores in comparison with usual management. Secondary hypotheses are that the intervention will result in a >= 30% decrease in FeNO in comparison with usual care at 6 months and >=40% increase in ICS medication adherence at 6 months. The central hypothesis has been formulated on the basis of reports that parents of children with acute exacerbations continue to have insufficient knowledge of asthma self-management yet are motivated to do what is best for their child. SNAPP incorporates monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS medication adherence and that will influence the child's future independence and chronic disease-management skills. Importantly, the investigators will use wireless medication monitors to accurately and objectively ascertain ICS medication adherence without patient effort. Parents are facile with and use wireless technology to organize their daily activities and for communicating. Incorporating this technology into health care and medication adherence is a logical next-step.
The investigators propose to test the hypotheses through the following Aim: To determine whether SNAPP meaningfully improves 6-month asthma control measured with the Asthma Control Test, airway inflammation measured using exhaled nitric oxide and ICS adherence compared with usual care, in an RCT of children with moderate or severe persistent asthma.
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Tennessee
-
Nashville, Tennessee, Vereinigte Staaten, 37232
- Vanderbilt Children's Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- TennCare Medicaid insurance, and an acute exacerbation (45% of our ED patients with acute asthma, section C.11.)
- Parent has a smartphone and wireless account that they agree to use for this study (if randomized to intervention group), anticipated residence in the Nashville Metropolitan Service Area for at least 12 months, willingness to participate in phone-based (wireless or landline) ACT-scoring monthly, and willingness to return at 3, 6 and 12 months for FeNO testing.
- The participant's PCP agrees that patient has moderate or severe persistent asthma and should be on ICS for at least the subsequent 12 months in accordance with NIH-NAEPP expert panel guidelines.87,88
Exclusion Criteria:
- Exclusion criteria include prior study enrollment, other medical condition contributing to respiratory distress (e.g., pneumonia, cystic fibrosis) or other diseases that may necessitate treatment with systemic corticosteroid (CCS; e.g., nephrotic syndrome).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Kontrolle
Kontrollgruppe
|
Asthma teaching
Andere Namen:
|
|
Experimental: Smartphone Asthma Control
|
Asthma teaching
Andere Namen:
Smartphone Asthma Control
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Childhood asthma control test
Zeitfenster: 6 months
|
Measurement of change of C-ACT at 6 months.
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fractional excretion of exhaled nitric oxide
Zeitfenster: 6 months
|
Measurement of change of FeNO at 6 months.
|
6 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Donald H Arnold, MD, MPH, Vanderbilt University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB 140934
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Asthma im Kindesalter
-
Meyer Children's Hospital IRCCSRekrutierungAsthma bei Kindern | Asthma akut | Asthmakrise | Asthma-KindheitItalien
-
Columbia UniversityChildren's Hospital of Philadelphia; National Heart, Lung, and Blood Institute... und andere MitarbeiterNoch keine RekrutierungAkute Asthma | Pädiatrisches Asthma | Nicht-invasive Überdruckbeatmung | BiPAPVereinigte Staaten
-
Vanderbilt University Medical CenterZurückgezogenAsthma bei Kindern | Asthmaanfall | Asthma akut | Akute Asthma-Exazerbation | Asthma; StatusVereinigte Staaten
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Noch keine Rekrutierung
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Noch keine RekrutierungAnhaltendes Asthma | Asthma (Diagnose) | Moderate Asthma-ExazerbationVereinigte Staaten
-
Massachusetts General HospitalRekrutierungAsthma | Asthma-Exazerbation | Asthma-Kontrollniveau | Asthma akutVereinigte Staaten
-
University of PittsburghNational Institute of Environmental Health Sciences (NIEHS)RekrutierungAsthma-Exazerbation | Asthma im Kindesalter | Luftverschmutzung, Verhaltensweisen zur Risikominderung | AsthmakontrolleVereinigte Staaten
-
The Children's Hospital of Zhejiang University...Noch keine Rekrutierung
-
Dr. Grace ParragaCyclomedica Australia PTY LimitedNoch keine Rekrutierung
-
Henan University of Traditional Chinese MedicineNoch keine Rekrutierung
Klinische Studien zur Asthma teaching in ER
-
Father Flanagan's Boys' HomeNational Institute on Deafness and Other Communication Disorders (NIDCD)Noch keine RekrutierungAutismus-Spektrum-Störung | Autismus | Autismus, Anfälligkeit für, 6Vereinigte Staaten
-
Dar Al Uloom UniversityAbgeschlossenMedizinische Ausbildung | Simulationsbasiertes LernenSaudi-Arabien
-
Chang Gung Memorial HospitalAbgeschlossenKommunikation | GesundheitsverhaltenTaiwan
-
Aydin Adnan Menderes UniversityNoch keine RekrutierungAusbildung | Studenten der Krankenpflege
-
Aydin Adnan Menderes UniversityNoch keine Rekrutierung
-
Aydin Adnan Menderes UniversityNoch keine RekrutierungAusbildung | Studenten der KrankenpflegeTruthahn
-
Ankara Yildirim Beyazıt UniversityRekrutierung
-
National Taiwan University HospitalAnmeldung auf Einladung
-
Hopital MontfortInstitut du Savoir MontfortAbgeschlossenGrundlegende LebenserhaltungKanada
-
Ottawa Hospital Research InstituteAbgeschlossen