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

NCT ID: NCT01572233

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Virus Infection, Response to Therapy of

Keywords

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Fatigue,Physical Activity,Hepatitis C Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patient with HCV Infection

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

Group Type EXPERIMENTAL

Personalized Physical Activity and Psycho-Education (PPAPE) Program

Intervention Type 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.

usual care

waiting list group with usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiow-ching Shun, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Siow-ching Shun, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Shiow-Ching Shun, PhD

Role: primary

Other Identifiers

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201103086RC

Identifier Type: -

Identifier Source: org_study_id