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Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection

Primary Purpose

Hepatitis C Virus Infection, Response to Therapy of

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Personalized Physical Activity and Psycho-Education (PPAPE) Program
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatitis C Virus Infection, Response to Therapy of focused on measuring Fatigue,Physical Activity,Hepatitis C Virus Infection

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy
  • Aged above 18

Exclusion Criteria:

  • None

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient with HCV Infection

usual care

Arm Description

Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group.

waiting list group with usual care

Outcomes

Primary Outcome Measures

Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection
Phase I of this project, the first and second year, the measurement time will be collected on the baseline (before treatment, T0), the 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) during treatment.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2012
Last Updated
December 26, 2012
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01572233
Brief Title
Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection
Official Title
Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This 4-year project will be guided by a biobehavioral model for the study of exercise interventions in two phases with the purposes to : explore the patients' physical activity preferences and develop doable activity lists during treatment period examine the changes of health-related physical fitness component over interferon treatment develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test its effects on decreasing fatigue, physical and psychological distress, and improving their health-related physical fitness and quality of life in patients with chronic hepatitis C receiving Interferon with Ribavirin Combination Therapy evaluate the outcome of the PPAPE program on increasing adherence to therapy, the sustained virological response (SVR) in 24 weeks after the end of treatment, and the time-consuming for education program during intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection, Response to Therapy of
Keywords
Fatigue,Physical Activity,Hepatitis C Virus Infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with HCV Infection
Arm Type
Experimental
Arm Description
Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
waiting list group with usual care
Intervention Type
Behavioral
Intervention Name(s)
Personalized Physical Activity and Psycho-Education (PPAPE) Program
Intervention Description
Effects of Personalized Physical Activity and Psycho-Education Program on Patients with HCV infection The third and fourth year, will be examine on the 12, 24, 36, and 48 weeks during the interferon treatment.
Primary Outcome Measure Information:
Title
Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection
Description
Phase I of this project, the first and second year, the measurement time will be collected on the baseline (before treatment, T0), the 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) during treatment.
Time Frame
4-year project

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy Aged above 18 Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siow-ching Shun, PhD
Phone
886-2-23123456
Ext
88439
Email
scshun@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiow-ching Shun, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PhD
Phone
886-2-23123456
Ext
88439
Email
scshun@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PhD

12. IPD Sharing Statement

Learn more about this trial

Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection

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