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

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ClinicalTrials.gov Identifier: NCT01572233
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : April 6, 2012
Last Update Posted : December 27, 2012
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

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 :

  1. explore the patients' physical activity preferences and develop doable activity lists during treatment period
  2. examine the changes of health-related physical fitness component over interferon treatment
  3. 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
  4. 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection, Response to Therapy of Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection
Study Start Date : December 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient with HCV Infection
Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group.
Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program
  1. Effects of Personalized Physical Activity and Psycho-Education Program on Patients with HCV infection
  2. The third and fourth year, will be examine on the 12, 24, 36, and 48 weeks during the interferon treatment.

No Intervention: usual care
waiting list group with usual care



Primary Outcome Measures :
  1. Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection [ Time Frame: 4-year project ]
    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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


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): NCT01572233


Contacts
Contact: Siow-ching Shun, PhD 886-2-23123456 ext 88439 scshun@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shiow-Ching Shun, PhD    886-2-23123456 ext 88439    scshun@ntu.edu.tw   
Principal Investigator: Shiow-Ching Shun, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Shiow-ching Shun, PhD National Taiwan University

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01572233     History of Changes
Other Study ID Numbers: 201103086RC
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
Fatigue,Physical Activity,Hepatitis C Virus Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections