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The Patient-Reported Outcomes Project of HCV-TARGET (PROP-UP)

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ClinicalTrials.gov Identifier: NCT02601820
Recruitment Status : Active, not recruiting
First Posted : November 10, 2015
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for HCV regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Harvoni®, Viekera Pak®, Zepatier®, DAC/SOF or SOF/VEL for chronic HCV will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment.

PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.


Condition or disease
Hepatitis C, Chronic Liver Diseases

Detailed Description:

Newer, more effective all-oral regimens for hepatitis C viral (HCV) infection are available. However the available data from industry-sponsored trials do not provide all the information that patients need, nor do these data represent the broad spectrum of patients treated in real-world practice. Trials also exclude disadvantaged subgroups, focus on short-term efficacy and clinician-rated adverse events, rarely obtain the patient's perspective, and do not investigate longer-term harms of treatment or benefits of viral cure. Given these informational gaps, patient-centered outcomes research (PCOR) on treatment harms and benefits that matter most to patients, is needed.

PROP UP is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate 5 newly approved DAA treatment regimens for HCV regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups.

PROP UP is a collaborative effort between researchers, a patient engagement group, and a patient advocacy organization. Nine U.S. liver centers will collaborate on PROP UP. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Harvoni®, Viekera Pak®, Zepatier®, DAC/SOF or SOF/VEL for chronic HCV will be consented and will complete baseline PRO surveys. Approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. Participants will complete several PRO surveys at 5 assessment periods during the study: baseline, treatment week 4, end of treatment, 3 months post-treatment, and 12 months post-treatment. PRO survey data will be collected via 3 options: patient home-based computers, tablet, smartphone; phone-administered surveys with a centralized call enter; or at regular clinic visits.

Analysis of PROs collected longitudinally before, during and after treatment for HCV will allow the investigators to answer a variety of questions important to patients and clinicians. Specifically, the investigators will evaluate: (a) prevalence of pre-existing baseline symptoms associated with HCV; (b) the development of new onset treatment side effects and exacerbation of pre-existing symptoms during HCV treatment; (c) medication adherence and out of pocket costs associated with treatment; (d) changes in HCV-associated symptoms and functional status in patients who are cured; (e) long-term patient-reported harms associated with treatments and long-term benefits associated with viral cure.


Study Type : Observational
Actual Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Patient-Reported Outcomes Project of HCV-TARGET (PROP UP)
Study Start Date : November 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : July 2018



Primary Outcome Measures :
  1. Overall Toxicity measured using the Memorial Symptom Assessment Scale [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
    Overall toxicity of treatment will be measured using the Memorial Symptom Assessment Scale (MSAS). The MSAS is a reliable and validated 32-item instrument that will be used to measure change in pre-existing HCV symptoms and new onset treatment side effects during HCV treatment. The MSAS evaluates 32 prevalent symptoms or side effects that commonly occur in medical populations and during medical treatments. Participants will indicate the presence or absence of a symptom/side effect, and if present, will rate the construct on severity, frequency and interference. An overall treatment toxicity score using all the items will be analyzed, as well as descriptive statistics about change in each symptom/side effect over time.


Secondary Outcome Measures :
  1. Change in Treatment Related Symptoms [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
    Treatment-related side effects-- fatigue, sleep disturbance, nausea/vomiting, diarrhea, irritability and anxiety-- will be measured using multiple shorts forms developed by the NIIH Patient-Reported Outcomes Measurement Information System® (PROMIS®). The number and severity of each incident will be collected and counted in order to create a report about the aggregate change in overall number of symptoms.

  2. Change in HCV-specific functional status [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
    HCV-specific functional status and well-being will be measured using the HCV-PRO.

  3. Cumulative out of pocket costs during HCV treatment [ Time Frame: Baseline to one year ]
    Cumulative out of pocket costs incurred by patients during HCV treatment will be measured by a survey recording 5 direct and 5 indirect costs of treatment.

  4. HCV medication adherence [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
    Medication adherence will be measured by the Voils' Medication Adherence Survey.

  5. Change in HCV symptoms, side effects and functional status 3-months post treatment [ Time Frame: Baseline to 3-months post-treatment ]
    Longitudinal change in HCV-associated symptoms, treatment side effects, and functional status will be evaluated by calculating the aggregate change in symptoms through counting the overall symptoms, etc reported through multiple PROMIS surveys and the HCV-PRO.

  6. Changes in HCV symptoms, side effects and functional status 1 year post treatment [ Time Frame: Longitudinal change from baseline to 1 year post-treatment ]
    Longitudinal change in HCV-associated symptoms, treatment side effects, and functional status will be evaluated by calculating the aggregate change in symptoms through counting the overall symptoms, etc reported through multiple PROMIS surveys and the HCV-PRO.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients being evaluated for Hep C treatment in 9 large academic liver centers in the US.
Criteria

Inclusion Criteria:

  • Diagnosed with HCV genotype 1-6
  • English-speaking
  • Age 21 or older
  • Medically cleared and being prescribed one of the following DAA regimens:

    • sofosbuvir/ledipasvir (Harvoni®) with or without ribavirin
    • ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekera Pak®), VPK) with or without ribavirin
    • elbasvir/grazoprevir (Zepatier®) with or without ribavirin
    • daclatasvir/sofosbuvir, with or without ribavirin (DAC/SOF)
    • sofosbuvir/velpatasvir (SOF/VEL)

Exclusion Criteria:

  • Inability to provide written informed consent
  • Currently participating in a pharmaceutical-sponsored drug trial of hepatitis C treatment
  • Major cognitive or mental impairment
  • Unable to read or speak English
  • Unwilling or unable to complete survey questionnaires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601820


Locations
United States, California
University of California at Davis
Davis, California, United States, 95616
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
St Louis University
Saint Louis, Missouri, United States, 63104
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States, 28403
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Donna M. Evon, PhD University of North Carolina, Chapel Hill

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02601820     History of Changes
Other Study ID Numbers: 15-1633
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
patient-reported outcomes
observational
HCV
Hepatitis
Hepatitis C
Chronic Liver Disease
Liver Disease
Liver
Infectious Disease
Hep C
HepC
PROs

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