Clinical trial NCT02006823: Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C
Official title: Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African-American or Caucasian patients with Type 1 Chronic Hepatitis C

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Change in Self Management
timeFrame: baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 18 weeks, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice Willis Clinic
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Donald Bailey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.