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

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01572233
First received: April 4, 2012
Last updated: December 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Hepatitis C Virus Infection, Response to Therapy of
 Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection [ Time Frame: 4-year project ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01572233     History of Changes
Other Study ID Numbers: 201103086RC
Study First Received: April 4, 2012
Last Updated: December 26, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 21, 2013