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

NCT01572233 | Unknown DMC

• 1 other identifier: 201103086RC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis C Virus Infection, Response to Therapy of

Keywords

Fatigue,Physical Activity,Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient with HCV Infection

EXPERIMENTAL

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

Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program

usual care

NO INTERVENTION

waiting list group with usual care

Interventions

Personalized Physical Activity and Psycho-Education (PPAPE) Program BEHAVIORAL

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.

Patient with HCV Infection

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Fatigue

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shiow-ching Shun, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siow-ching Shun, PhD

CONTACT

886-2-23123456; scshun@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: December 27, 2012

Record last verified: 2012-11

Locations

TW (1)