Hepatitis C Virus Infection, Response to Therapy ofNCT01572233
Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection
A study testing Personalized Physical Activity and Psycho-Education (PPAPE) Program in people with Hepatitis C Virus Infection, Response to Therapy of, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatitis C Virus Infection, Response to Therapy of
- What is being tested?
- Personalized Physical Activity and Psycho-Education (PPAPE) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy
- Aged above 18
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Shiow-Ching Shun, PhD, 886-2-23123456 ext. 88439, scshun@ntu.edu.tw
Shiow-Ching Shun, PhD
About this study
Official title: Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection
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.
- Being tested
- Personalized Physical Activity and Psycho-Education (PPAPE) Program
- Keywords
- Fatigue,Physical Activity,Hepatitis C Virus Infection
- Medical subject headings
- Hepatitis C, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Physical Activity and Psycho-Education (PPAPE) ProgramBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with HCV Infection | Experimental | Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group. Receives: Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program |
| usual care | No intervention | waiting list group with usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-year project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus Infection, Response to Therapy ofStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Shiow-ching Shun, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572233
- Sponsor's protocol ID
- 201103086RC
- Status last verified
- Nov 2012
- First submitted
- 4 Apr 2012
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01572233
- Acronym / sponsor ID
- 201103086RC
- Keywords
- Fatigue,Physical Activity,Hepatitis C Virus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Dec 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with HCV Infection | Experimental | Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) ProgramPersonalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group. |
| usual care | No intervention | –waiting list group with usual care |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy
- Aged above 18
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Physical Activity and Psycho-Education (PPAPE) Program1. 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. | Behavioural | Patient with HCV Infection |
Primary outcome
Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiow-ching Shun, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Physical Activity and Psycho-Education (PPAPE) Program in people with Hepatitis C Virus Infection, Response to Therapy of, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siow-ching Shun, PhD (886-2-23123456 ext. 88439, scshun@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection (time frame: 4-year project). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2012; AzTrials last refreshed its copy on 6 Nov 2026.