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

Hepatitis C Virus Infection, Response to Therapy of Clinical Trial

Official title:

Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01572233
• Other study ID #: 201103086RC
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2012
• Last updated: December 26, 2012
• Start date: December 2011
• Est. completion date: June 2018

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: Siow-ching Shun, PhD
• Phone: 886-2-23123456
• Email: scshun[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy

• Aged above 18

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection, Response to Therapy of
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-year project	No