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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02006823
First received: November 22, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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).


Condition
Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 22
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

African-American or Caucasian patients with Type 1 Chronic Hepatitis C

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006823

Contacts
Contact: Donald Bailey, PhD (919) 681 3003 Chip.Bailey@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Donald Bailey, PhD    919-681-3003    chip.bailey@duke.edu   
Contact: , PhD         
Principal Investigator: Donald Bailey, PhD         
Boice Willis Clinic Active, not recruiting
Rocky Mount, North Carolina, United States, 27804
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Donald Bailey, PhD Duke University School of Nursing
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02006823     History of Changes
Other Study ID Numbers: Pro00035949
Study First Received: November 22, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014