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Monitoring Adherence Using Mobile Technology

14. september 2016 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

25

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Enhed: Propeller Health Monitoring Device

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Colorado, Denver

Efterforskere

  • Ledende efterforsker: Stanley Szefler, MD, University of Colorado, Denver

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2015

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

24. november 2015

Først indsendt, der opfyldte QC-kriterier

25. november 2015

Først opslået (Skøn)

1. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15-0211

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Propeller Health Monitoring Device

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner