Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C

Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C

Sponsoren

Hauptsponsor: Duke University

Quelle Duke University
Kurze Zusammenfassung

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).

Gesamtstatus Completed
Anfangsdatum March 2012
Fertigstellungstermin July 2014
Primäres Abschlussdatum July 2014
Studientyp Observational
Primärer Ausgang
Messen Zeitfenster
Change in Self Management baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 18 weeks, 24 weeks
Einschreibung 20
Bedingung
Teilnahmeberechtigung

Probenahmeverfahren: Non-Probability Sample

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Donald Bailey, PhD Principal Investigator Duke University School of Nursing
Ort
Einrichtung:
Duke University Medical Center | Durham, North Carolina, 27710, United States
Boice Willis Clinic | Rocky Mount, North Carolina, 27804, United States
Standort Länder

United States

Überprüfungsdatum

December 2014

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Prospective

Quelle: ClinicalTrials.gov