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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01572233

Collaborator

National Health Research Institutes, Taiwan (Other)

300

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection, Response to Therapy of	Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

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 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.
No Intervention: usual care waiting list group with usual care

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

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.

No Intervention: usual care

waiting list group with usual care

Outcome Measures

Primary Outcome Measures

Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection [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.