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Prospective Study of the Feedback From an Adherence Monitor on Asthma Control (INCA)

11. januar 2016 opdateret af: Professor Richard Costello, Beaumont Hospital

Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration

The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.

In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

220

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Irland
      • Dublin, Irland, Dublin 9
        • Beaumont Hospital

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months
  • At least one exacerbation in the previous year with systemic glucocorticoids
  • Uncontrolled/Partially Controlled Asthma by GINA guidelines

Exclusion Criteria:

  • Allergy to salmeterol/fluticasone
  • Patients Controlled by GINA guidelines

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active Feedback
In this arm patients will receive monthly review and education on inhaler technique and use based on a computer download of their last month of inhaler use
Adfærdsmæssigt: Active Feedback
The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.
Andre navne:
  • Feedback from a computer log of inhaler use
Placebo komparator: Control
In this arm patients will be reviewed monthly, however will not have information from INCA device to tailor inhaler education.
Adfærdsmæssigt: Active Feedback
The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.
Andre navne:
  • Feedback from a computer log of inhaler use

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence rate
Tidsramme: at three months
The rate of actual adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed. The actual inhaler adherence, expressed as cumulative drug exposure, is calculated by combining the time of use along with the interval between doses (correct time is twice a day, in a period not less than 6 hours between the last dose and the subsequent dose or at a time greater than 18 hours apart from the previous dose.) and incorporating, by audio analysis, if the inhaler was used correctly.
at three months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Asthma quality of life score
Tidsramme: at 3 months
The asthma quality of life score will be related to adherence, The baseline asthma quality of life score and the quality of life score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
at 3 months
Peak Expiratory Flow Rate
Tidsramme: at 3 months
The peak expiratory flow rate will be related to adherence, The baseline peak expiratory flow rate and the peak expiratory flow rate at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
at 3 months
Asthma Control Test
Tidsramme: at 3 months
The asthma control test score will be related to adherence, The baseline asthma control test score and the score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
at 3 months
Asthma Exacerbations
Tidsramme: over 3 months
The frequency in exacerbations over the three months will be compared between the active and control arms.
over 3 months
Asthma Reliever Medication Use
Tidsramme: over 3 months
The change in frequency of reliever use per month from baseline to the end of the study will be compared between active and control patients.
over 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Beaumont Hospital

Efterforskere

  • Ledende efterforsker: Richard Costello, MD, Beaumont Hospital

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. februar 2012

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

7. februar 2012

Først indsendt, der opfyldte QC-kriterier

8. februar 2012

Først opslået (Skøn)

9. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BeaumontH

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 .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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