Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Understanding Patient Management of COPD Exacerbations

29 marzo 2019 aggiornato da: Vincent S. Fan, VA Puget Sound Health Care System
This observational study will examine the care-seeking behaviors of Veterans with chronic obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack of access to care leads to delays in getting care for COPD exacerbations. Participants complete a baseline in-person visit and receive calls every two weeks for one year to monitor for COPD exacerbations. Detailed information about each exacerbation and time to care are obtained. A sample of participants and their caregivers participate in in-depth interviews. Approximately half the participants will also use a remote inhaler monitor to record their albuterol inhaler use to see if this approach can identify early exacerbations. Results from this study will be used to develop an intervention that will assist Veterans in the early identification, evaluation, and treatment of exacerbations, and will be integrated with the VA primary care team.

Panoramica dello studio

Descrizione dettagliata

Prompt treatment of chronic obstructive pulmonary disease (COPD) exacerbations with oral steroids and/or antibiotics, ideally within 3 days of onset of symptoms, can decrease the severity and duration of exacerbations and may reduce the risk of COPD hospitalizations. This observational study will examine Veterans' care-seeking behaviors and will focus on patients' perceived need for care and perceived access to care and whether these factors delay seeking care for COPD exacerbations, increasing the risk for hospitalizations. This study will also evaluate one approach of identifying early exacerbations through the use of a remote inhaler monitoring system.

This observational cohort study enrolled 412 Veterans with COPD at high-risk for exacerbations. As of March 2019, 246 participants have completed the 1 year follow-up; 133 are in follow-up. The Specific Aims are: 1) Examine the barriers to seeking care for COPD exacerbations or worsening breathing; 2) Test the use of a real-time remote inhaler monitor to identify early exacerbations.

All participants attended one in-person baseline visit to complete spirometry and baseline questionnaires. Participants are contacted every 2 weeks for 1 year using an interactive voice response system that screens for COPD exacerbations with 4 yes/no questions. Participants with a positive screen are called back by research staff to obtain additional detailed information on the exacerbation and how it was treated. Data analysis will examine whether access to care and baseline factors are associated with a delay in treatment.

The participants enrolled at two sites: 252 participants at VA Puget Sound in Seattle, WA and 160 participants at the VA Eastern Colorado in Denver, CO. For Aim 1, 60 participants who reported a COPD exacerbation (either hospitalized, seen in the emergency department, treated as outpatients, or did not seek treatment) participated in in-depth semi-structured interviews by a trained research staff to understand how they responded to their worsening symptoms and decided whether to seek care. 24 caregivers for these Veterans were interviewed about their perspective on the exacerbation event.

In Aim 2, 145 participants from Aim 1 used an inhaler monitor with their albuterol inhaler during the 12-month follow-up period, which transmits real-time data about their daily inhaler use. Data analysis will measure whether a change in albuterol use can predict patient reported COPD exacerbations to determine the appropriate cut-offs that can be used in a future intervention trial.

These aims will provide detailed information on how best to intervene to ensure prompt identification and treatment of COPD exacerbations. New health care delivery approaches will assist Veterans in early identification of exacerbations and provide early access to care that can be integrated into the VA primary care, emergency medicine and pulmonary specialty care settings.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

436

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with chronic obstructive pulmonary disease (COPD) who receive care at the VA Puget Sound Health Care System in Seattle, WA or the VA Eastern Colorado Health Care System in Denver, CO. Informal caregivers (ie. family member or friend) to the Veteran subject will also be included

Descrizione

Veteran Cohort:

Inclusion Criteria:

  1. COPD diagnosis
  2. Spirometry showing FEV1/VC<0.70
  3. COPD exacerbation treated with prednisone and/or antibiotics, or that resulted in a visit to the emergency department or hospitalization in the previous 12 months
  4. English speaking
  5. Access to telephone

Exclusion Criteria:

  1. nursing home resident
  2. institutionalized, imprisoned
  3. life expectancy < 1 year

Informal Caregiver Cohort:

Inclusion Criteria:

  1. Identified by Veteran patient as informal caregiver
  2. English speaking
  3. Access to telephone
  4. >=18 years old

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
COPD patients
Veterans with COPD who are cared for at VA Puget Sound Health Care System (Seattle, WA) or VA Eastern Colorado (Denver, CO) who are at high risk for a COPD exacerbation based on an exacerbation treated with prednisone or antibiotics in the year preceding enrollment.
Not applicable. This is an observational study without an intervention.
Informal Caregiver for COPD patients
Informal caregiver (ie. family member, friend, etc.) for the patient with COPD who is participating in the COPD patients cohort.
Not applicable. This is an observational study without an intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Decision to seek care
Lasso di tempo: Determined for each exacerbation event during the 1-year follow-up period
All participants with at least one exacerbation will be included in this analysis. Individuals could have both treated or untreated exacerbations and the unit of analysis will be each patient-exacerbation event. The outcome will be whether the patient sought treatment (yes/no) for their COPD exacerbation.
Determined for each exacerbation event during the 1-year follow-up period

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment delay
Lasso di tempo: Determined for each treated exacerbation event during the 1-year follow-up period
Only patients with ≥1 treated exacerbation during follow-up will be included in this analysis. A patient could have more than one exacerbation, and the unit of analysis will be each patient-exacerbation event
Determined for each treated exacerbation event during the 1-year follow-up period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2016

Completamento primario (Anticipato)

1 novembre 2019

Completamento dello studio (Anticipato)

1 marzo 2022

Date di iscrizione allo studio

Primo inviato

28 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

28 marzo 2016

Primo Inserito (Stima)

31 marzo 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 00874

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

Sottoscrivi