- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00783848
Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
The purpose of this research study is to learn about the experience and impact of having congestive heart failure (CHF). In particular, we hope to develop better questionnaires that can measure heart failure patients' quality-of-life.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This project will assess the validity (including responsiveness) of selected Patient Reported Outcome Measurement Information System (PROMIS) instruments in patients with severe CHF who receive heart transplants. The following is a list of goals for this project:
- To estimate the responsiveness of PROMIS domain scores by comparing scores in patients with severe heart failure before and after a clinically significant event (heart transplant). The specific PROMIS domains assessed are physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
- To estimate the responsiveness of a disease-specific patient-reported outcome (PRO) measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short Form-36 Vitality subscale (SF-36v2), and the Patient Health Questionnaire (PHQ-2).
- To collect cross-sectional and longitudinal data on traditional clinical measures of heart failure outcome (6-minute walk test and New York Heart Association [NYHA] class) that can inform the definition of a minimally important difference (MID) for the PROMIS domains of physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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California
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Palo Alto, California, Stati Uniti, 94305
- Stanford University
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh Medical Center
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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:
- Heart failure had to represent the greatest medical limitation on daily function for the patient in the judgment of the attending cardiologist
- Ability to read, write, and speak in English
- Ability to understand and provide informed consent
- Placement on heart transplant registry (awaiting heart transplant surgery)
Exclusion Criteria:
- Current diagnosis of psychosis or dementia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Evaluate the validity (including responsiveness) of selected PROMIS domains for patients with severe heart failure who receive a heart transplant.
Lasso di tempo: baseline and 8-12 weeks post-transplant
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Clinical and patient-reported assessments will be performed at baseline and 8-12 weeks 86 (end of study).
Clinical indicators of functioning will include the New York Heart 87 Association (NYHA) classification and the six-minute walk test.
We will include the 88 Kansas City Cardiomyopathy Questionnaire (KCCQ), a disease-specific measure of health-89 related quality of life (HRQOL), as a point of reference for understanding the relative 90 validity (including responsiveness) of the PRPROMIS item banks.
Instruments will include 91 PROMIS computerized adaptive tests (CATS).
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baseline and 8-12 weeks post-transplant
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kevin Weinfurt, PhD, Duke University
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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
- Pro00009919
- 5U01AR052186-02 (Sovvenzione/contratto NIH degli Stati Uniti)
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 .
Prove cliniche su Insufficienza cardiaca congestizia
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Region SkaneIscrizione su invitoInsufficienza cardiaca Classe II della New York Heart Association (NYHA). | Insufficienza cardiaca Classe III della New York Heart Association (NYHA).Svezia
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... e altri collaboratoriNon ancora reclutamentoInsufficienza cardiaca, sistolica | Insufficienza cardiaca con frazione di eiezione ridotta | Scompenso cardiaco Classe IV della New York Heart Association | Scompenso cardiaco Classe III della New York Heart AssociationPolonia
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University of WashingtonAmerican Heart AssociationCompletatoInsufficienza cardiaca, congestizia | Alterazione mitocondriale | Scompenso cardiaco Classe IV della New York Heart AssociationStati Uniti