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

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ClinicalTrials.gov Identifier: NCT02006823
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

November 22, 2013
December 10, 2013
December 15, 2014
March 2012
July 2014   (Final data collection date for primary outcome measure)
Change in Self Management [ Time Frame: baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 18 weeks, 24 weeks ]
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.
Same as current
Complete list of historical versions of study NCT02006823 on ClinicalTrials.gov Archive Site
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Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C
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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
African-American or Caucasian patients with Type 1 Chronic Hepatitis C
Chronic Hepatitis C
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Bailey DE Jr, Hendrix CC, Steinhauser KE, Stechuchak KM, Porter LS, Hudson J, Olsen MK, Muir A, Lowman S, DiMartini A, Salonen LW, Tulsky JA. Randomized trial of an uncertainty self-management telephone intervention for patients awaiting liver transplant. Patient Educ Couns. 2017 Mar;100(3):509-517. doi: 10.1016/j.pec.2016.10.017. Epub 2016 Oct 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
22
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02006823
Pro00035949
No
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Duke University
Duke University
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Principal Investigator: Donald Bailey, PhD Duke University School of Nursing
Duke University
December 2014