- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02006823
Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C
This study will explore ways to improve the effectiveness of patient Self Management at a time when genetic test results guide new treatments that will dramatically increase the possibility of cure of the hepatitis C virus.The study will also focus on the interactions between provider and patients and the ways that technical work, adaptive work and adaptive leadership foster patient self-management.This proposed 2 year exploratory mixed-methods 12 longitudinal case study will explore patients' and providers' explanations for how and why they engage in technical work, adaptive work, and adaptive leadership and the ways in which these strategies promote or pose barriers to patients' self-management of Chronic Hepatitis C in the context of the new genetic test results and treatments. Specific aims are to:
1: Examine how technical work, adaptive work and adaptive leadership influence patients' perceptions of their likelihood of cure and how this work relates to self-management during 12 to 24 weeks of treatment for Chronic Hepatitis C. Research questions are: 1.1) How do patients describe their interactions with the providers? 1.2) How do these interactions shape patients' perceptions of the likelihood of cure? 1.3) How do patients' understanding of their interactions with the provider promote the use of or pose barriers to self-management during treatment?
AIM 2: Describe providers' use of technical work, and adaptive leadership approaches during clinical encounters,to include nurse education visits. Research questions are:
2.1) What technical work, and adaptive leadership approaches do providers use when sharing treatment information with patients during the clinical encounters. 2.2) What explanations do providers give for how and why they use technical work and adaptive leadership approaches? AIM 3: Describe the trajectories of illness perceptions(Control/Cure sub-scale - Illness Perception Scale), symptoms (M.D. Anderson Symptom Inventory) , viral load, and self-management (Patient Activation Measure) in relation to patient and provider reports of technical work, adaptive work, and adaptive leadership from the index clinical encounter to the follow-up treatment response encounter (ranging from 12 to 24 weeks).
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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Rocky Mount, North Carolina, Stati Uniti, 27804
- Boice Willis Clinic
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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:
- African American or Caucasian
- Genotype 1
- Planning to, but have not yet, began treatment for Hepatitis C at Duke University Medical Center or Boice-Willis Clinic in Rocky Mount, NC
Exclusion Criteria:
- Diagnosed with Bipolar Disorder or Schizophrenia
- Not genotype 1
- Any race other than African American or Caucasian.
- Hispanic or Latino
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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Change in Self Management
Lasso di tempo: baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 18 weeks, 24 weeks
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Self Management as measured by the Patient Activation Measure which is an measure of their responses.
The study team will plot a trajectory line using the Patient Activation Measure across all time points.
The team is interested in knowing if this measure changes based on the patients self-management and his/her interaction with the health care provider.
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baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 18 weeks, 24 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Donald Bailey, PhD, Duke University School of Nursing
Pubblicazioni e link utili
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
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite
- Epatite A
- Epatite C
- Epatite cronica
- Epatite C, cronica
Altri numeri di identificazione dello studio
- Pro00035949
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 .