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

7 de agosto de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

1601

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

21 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: Coorte
Perspectivas de Tempo: Prospectivo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of North Carolina, Chapel Hill

Colaboradores

Patient-Centered Outcomes Research Institute

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2015

Conclusão Primária (Real)

1 de julho de 2018

Conclusão do estudo (Real)

1 de julho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

3 de novembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de novembro de 2015

Primeira postagem (Estimativa)

10 de novembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de setembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de agosto de 2019

Última verificação

1 de outubro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

15-1633

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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