Monitoring Adherence Using Mobile Technology
14. september 2016 oppdatert av: University of Colorado, Denver
This study plans to learn more about how children use their asthma medicines.
The investigators would like to see if special electronic monitoring devices that connect to smartphones and computers can help children to better manage their asthma
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
25
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Study subjects would be drawn from the list of high risk asthma patients and by pre-clinic chart review done by study investigator.
Beskrivelse
Inclusion Criteria:
- age 6-17 years and their parents
- either 2 emergency department visits/prednisone bursts in the last 12 months or at least 1 asthma related hospitalization in the last 12 months
- requiring daily controller therapy with either inhaled corticosteroids or combination corticosteroids/long acting beta agonist (LABA).
- Patients using metered dose inhaler therapy would be eligible. Patients may also be on leukotriene antagonists,
- Must be made aware that they will have to read and accept to the terms of the User Agreement prior to enrollment in the study. If they do not agree they will not be able to continue participation. The User agreement will be read agreed to electronically when they begin using the device, however a paper version will be provided at the time of consent upon request.
Exclusion Criteria:
- Primary language other than English or Spanish
- Presence of other significant chronic lung disease including cystic fibrosis, interstitial lung disease, tracheostomy status.
- Patients using diskus therapy.
- Patients only on leukotriene antagonists.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Intervention
All patients will be enrolled in one arm.
These patients will have monitoring devices placed on their asthma controller and rescue medication, with data transmitted both to their smartphones and a dashboard accessed by their primary pediatric pulmonary provider.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patient participants that rate the devices as easy to use
Tidsramme: 3 months
|
Measuring the feasibility and acceptability of monitoring devices for children ages 6-17 who are at high risk for asthma exacerbation, by having children use the devices and having children/parents answer survey questions regarding their impressions of the product at the beginning of use and after 1.5 and 3 months of use.
|
3 months
|
|
Number of provider participants that rate the devices as easy to use
Tidsramme: 3 months
|
Measuring the feasibility and acceptability of monitoring devices for children ages 6-17 who are at high risk for asthma exacerbation, by having children use the devices and having providers answer survey questions regarding their impressions of the product at the beginning of use and after 1.5 and 3 months of use.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patients/parents that exhibit behavioral changes with respect to taking asthma medications as a result of information gained from the monitoring devices.
Tidsramme: 3 months
|
How many parents/patients of high risk asthmatic children change behavior regarding how they administer their medications as a result of information that they gained from the devices regarding their adherence to their treatment regimen, gained via phone surveys at 1.5 and 3 months after using the devices.
Patients are surveyed if children are greater than 12 years old.
Parents are surveyed if children are 6-12 years old.
|
3 months
|
|
Number of pediatric pulmonary providers that exhibit behavioral changes with respect to prescribing asthma medications as a result of information gained from the monitoring devices.
Tidsramme: 3 months
|
Number of healthcare providers (physicians, nurse practitioners and physician assistants) that feel that their decision-making is affected regarding medication regimens for asthma based on information that they receive on patient adherence from the devices based on survey data gathered at study entry and 3 months after initiation of the devices will be measured.
|
3 months
|
|
Correlation of lung function to percent use of controller medications as measured by adherence devices.
Tidsramme: 3 months
|
Evaluate correlation of markers of lung function (spirometry, fractional exhaled nitric oxide (FeNO), with percent adherence as measured by the monitoring devices.
|
3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Stanley Szefler, MD, University of Colorado, Denver
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2015
Primær fullføring (Faktiske)
1. september 2016
Studiet fullført (Faktiske)
1. september 2016
Datoer for studieregistrering
Først innsendt
24. november 2015
Først innsendt som oppfylte QC-kriteriene
25. november 2015
Først lagt ut (Anslag)
1. desember 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. september 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2016
Sist bekreftet
1. september 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 15-0211
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .