- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00784342
Validation of PROMIS Banks With COPD Exacerbations
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is a prospective longitudinal study of adult patients with chronic obstructive pulmonary disease (COPD) who will be enrolled when their COPD is considered clinically stable or during an acute exacerbation. This design will allow both within-person and between-person comparisons by exacerbation experience. Comprehensive clinical and patient-reported assessments will be performed at baseline and at 3 months (end of study). Subsets of items will be administered by interactive voice response (IVR) over the course of the study to measure changes in key symptoms over the course of recovery from an exacerbation. A subset of patients will be interviewed at the end of the study to assess content validity of PROMIS items in this patient population.
With such a study design, we will be able to evaluate the validity of the PROMIS items in this patient population under acute and stable conditions and evaluate responsiveness of several PROMIS item banks under conditions of known change in an underlying chronic disease. We will also evaluate stability of sub-domains that are not hypothesized to change with COPD exacerbations.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Illinois
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Evanston, Illinois, Stati Uniti, 60201
- NorthShore University HealthSystem (Formerly Evanston Northwestern Healthcare)
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, Stati Uniti, 27701
- Duke University
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15261
- University of Pittsburgh
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Pittsburgh, Pennsylvania, Stati Uniti, 15240
- Pittsburgh VA Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- An established clinical history of COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) definition: COPD is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.
- A history of smoking (at least 10 pack/year history)
- Access to and able to communicate on a touch tone telephone
- Read and speak English
- Able to see and interact with a computer screen, mouse, and keyboard
- A signed and dated written informed consent prior to study participation
- For those enrolled into the exacerbation group: Treatment for an exacerbation may have been started no more than 3 days prior to the day of enrollment for patients recruited in the outpatient setting and no more than 6 days prior to the day of enrollment for patients recruited in the in-patients setting.
- For those enrolled in the stable state group, the patient will be considered stable if he or she has been exacerbation-free for a minimum of 2 months prior to enrollment.
Exclusion Criteria:
- Any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render the participant unable to complete a questionnaire)
- History of asthma without co-existent COPD as the primary diagnosis
- Experiencing a current heart failure exacerbation. (A diagnosis of heart failure is not in itself an exclusion criterion.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Stable
Patients who are stable have not had a COPD exacerbation in the past 2 months.
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Exacerbation
Patients with an exacerbation have been diagnosed and started on treatment for an exacerbation within the past 3 days.
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Darren A. Dewalt, MD, MPH, University of North Carolina, Chapel Hill
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 07-02
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 .