Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02601820
Recruitment Status : Completed
First Posted : November 10, 2015
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
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 chronic hepatitis C viral (HCV) infection 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 Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) 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 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 newly approved direct acting antiviral (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. Eleven U.S. liver centers will collaborate on PROP UP. Approximately 1920 patients with HCV infection who are prescribed a DAA regimen 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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 1601 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 : July 2018
Actual Study Completion Date : July 2018



Primary Outcome Measures :
  1. Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment [ Time Frame: Baseline to up to 24 weeks of HCV Treatment ]

    Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score.

    Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden.

    To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful.



Secondary Outcome Measures :
  1. Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment [ Time Frame: Baseline to up to 24 weeks of HCV Treatment ]

    Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved.

    1. PROMIS Fatigue-7 mean change score range = +/- 53.9
    2. PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1
    3. PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0
    4. PROMIS Diarrhea-6 mean change score range = +/- 42.8
    5. PROMIS Anger-5 mean change score range = +/- 50.5.
    6. PROMIS Anxiety-4 mean change score range = +/- 41.4
    7. HIT-6 mean change score range = +/- 42

    To aid in interpretation of clinical significance, a 5% change from baseline is considered a "minimally important change (MIC)." The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points.


  2. Change in HCV-PRO Mean Scores From Baseline to On-Treatment [ Time Frame: Baseline to up to 24 weeks of HCV Treatment ]

    HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.

    The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score.

    HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.

    To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful.


  3. Cumulative Out of Pocket Costs During HCV Treatment [ Time Frame: Up to 24 weeks of HCV Treatment ]

    Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended.

    The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4.


  4. Percentage of Participants With Nonadherence During HCV Treatment [ Time Frame: Up to 24 weeks of HCV Treatment ]
    Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or <100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3).

  5. Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment [ Time Frame: Baseline to 3-months post-treatment ]

    Change in "Overall Symptom Burden" from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS).

    The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score.

    Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.

    TMSAS Mean Change Scores could range from +/- 4.

    To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful.


  6. Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment [ Time Frame: Baseline to 3-months post-treatment ]

    Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved

    1. PROMIS Fatigue mean change score range = +/- 53.9
    2. PROMIS Sleep Disturbance mean change score range = +/- 47.1
    3. PROMIS Nausea mean change score range = +/- 44.0
    4. PROMIS Diarrhea mean change score range = +/- 42.8
    5. PROMIS Anger mean change score range = +/- 50.5.
    6. PROMIS Anxiety mean change score range = +/- 41.4
    7. PROMIS Depression mean change score range = +/- 43.1
    8. PROMIS Cognitive Concern mean change score range = +/- 39.5
    9. PROMIS Pain mean change score range = +/- 36.4
    10. PROMIS Belly Pain mean change score range = +/- 50.2
    11. Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically "minimally important change" (MIC). The 5% MIC = +/- 2.5 points.

    Change scores were calculated for two subgroups: Patients who did and did not achieve SVR


  7. Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment [ Time Frame: Baseline to 3-months post-treatment ]

    HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO."

    The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.

    HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.

    To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful.


  8. Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment [ Time Frame: Baseline to 1 year post-treatment ]

    Change in "Overall Symptom Burden" from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score.

    Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.

    TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful


  9. Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment [ Time Frame: Baseline to 1 year post-treatment ]

    Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved

    1. PROMIS Fatigue mean change score range = +/- 53.9
    2. PROMIS Sleep Disturbance mean change score range = +/- 47.1
    3. PROMIS Nausea mean change score range = +/- 44.0
    4. PROMIS Diarrhea mean change score range = +/- 42.8
    5. PROMIS Anger mean change score range = +/- 50.5.
    6. PROMIS Anxiety mean change score range = +/- 41.4
    7. PROMIS Depression mean change score range = +/- 43.1
    8. PROMIS Cognitive Concern mean change score range = +/- 39.5
    9. PROMIS Pain mean change score range = +/- 36.4
    10. PROMIS Belly Pain mean change score range = +/- 50.2
    11. Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically "minimally important change" (MIC). The 5% MIC = +/- 2.5 points.

    Change scores were calculated for two subgroups: Patients who did and did not achieve SVR


  10. Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment [ Time Frame: Baseline to 1 year post-treatment ]

    HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.

    The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score.

    Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.

    HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.

    To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 and two private gastroenterology practices 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 (SOF/LED) with or without ribavirin
    • ombitasvir/paritaprevir/ritonavir with dasabuvir (PRoD), with or without ribavirin
    • elbasvir/grazoprevir (ELB/GRZ) 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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Donna M. Evon, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019
Last Verified: October 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 C
Liver Disease
Liver
Infectious Disease
PROs
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic