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

7. August 2019 aktualisiert von: University of North Carolina, Chapel Hill

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

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

1601

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Vereinigte Staaten
- California
  - Davis, California, Vereinigte Staaten, 95616
    - University of California at Davis
- Connecticut
  - New Haven, Connecticut, Vereinigte Staaten, 06520
    - Yale University
- Florida
  - Gainesville, Florida, Vereinigte Staaten, 32611
    - University of Florida
- Illinois
  - Chicago, Illinois, Vereinigte Staaten, 60612
    - RUSH University
- Michigan
  - Ann Arbor, Michigan, Vereinigte Staaten, 48109
    - University of Michigan
- Missouri
  - Saint Louis, Missouri, Vereinigte Staaten, 63104
    - St Louis University
- North Carolina
  - Asheville, North Carolina, Vereinigte Staaten, 28801
    - Asheville Gastroenterology Associates
  - Chapel Hill, North Carolina, Vereinigte Staaten, 27599
    - University of North Carolina at Chapel Hill
  - Wilmington, North Carolina, Vereinigte Staaten, 28403
    - Wilmington Gastroenterology Associates
- Pennsylvania
  - Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
    - University of Pennsylvania
- Virginia
  - Richmond, Virginia, Vereinigte Staaten, 23298
    - Virginia Commonwealth University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients being evaluated for Hep C treatment in 9 large academic liver centers and two private gastroenterology practices in the US.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Beobachtungsmodelle: Kohorte
Zeitperspektiven: Interessent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment Zeitfenster: 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.	Baseline to up to 24 weeks of HCV Treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment Zeitfenster: 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. PROMIS Fatigue-7 mean change score range = +/- 53.9 PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1 PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0 PROMIS Diarrhea-6 mean change score range = +/- 42.8 PROMIS Anger-5 mean change score range = +/- 50.5. PROMIS Anxiety-4 mean change score range = +/- 41.4 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.	Baseline to up to 24 weeks of HCV Treatment
Change in HCV-PRO Mean Scores From Baseline to On-Treatment Zeitfenster: 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.	Baseline to up to 24 weeks of HCV Treatment
Cumulative Out of Pocket Costs During HCV Treatment Zeitfenster: 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.	Up to 24 weeks of HCV Treatment
Percentage of Participants With Nonadherence During HCV Treatment Zeitfenster: 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).	Up to 24 weeks of HCV Treatment
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment Zeitfenster: 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.	Baseline to 3-months post-treatment
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment Zeitfenster: 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 PROMIS Fatigue mean change score range = +/- 53.9 PROMIS Sleep Disturbance mean change score range = +/- 47.1 PROMIS Nausea mean change score range = +/- 44.0 PROMIS Diarrhea mean change score range = +/- 42.8 PROMIS Anger mean change score range = +/- 50.5. PROMIS Anxiety mean change score range = +/- 41.4 PROMIS Depression mean change score range = +/- 43.1 PROMIS Cognitive Concern mean change score range = +/- 39.5 PROMIS Pain mean change score range = +/- 36.4 PROMIS Belly Pain mean change score range = +/- 50.2 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	Baseline to 3-months post-treatment
Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment Zeitfenster: 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.	Baseline to 3-months post-treatment
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment Zeitfenster: 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	Baseline to 1 year post-treatment
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment Zeitfenster: 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 PROMIS Fatigue mean change score range = +/- 53.9 PROMIS Sleep Disturbance mean change score range = +/- 47.1 PROMIS Nausea mean change score range = +/- 44.0 PROMIS Diarrhea mean change score range = +/- 42.8 PROMIS Anger mean change score range = +/- 50.5. PROMIS Anxiety mean change score range = +/- 41.4 PROMIS Depression mean change score range = +/- 43.1 PROMIS Cognitive Concern mean change score range = +/- 39.5 PROMIS Pain mean change score range = +/- 36.4 PROMIS Belly Pain mean change score range = +/- 50.2 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	Baseline to 1 year post-treatment
Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment Zeitfenster: 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.	Baseline to 1 year post-treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of North Carolina, Chapel Hill

Mitarbeiter

Patient-Centered Outcomes Research Institute

Ermittler

Hauptermittler: Donna M. Evon, PhD, University of North Carolina, Chapel Hill

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2015

Primärer Abschluss (Tatsächlich)

1. Juli 2018

Studienabschluss (Tatsächlich)

1. Juli 2018

Studienanmeldedaten

Zuerst eingereicht

3. November 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. November 2015

Zuerst gepostet (Schätzen)

10. November 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. August 2019

Zuletzt verifiziert

1. Oktober 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

15-1633

Plan für individuelle Teilnehmerdaten (IPD)

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Nein

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