Peritoneal DialysisNCT01195519
The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis
An observational study of Peritoneal Dialysis and Hemodialysis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis and hemodialysis related issues. There is no study related to establish the predictive model of quality of life. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Dialysis, Hemodialysis
- How many people
- 95 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Sep 2011
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: peritoneal dialysis and hemodialysis patients
Who may be able to join
- above 20 years old PD or HD patients
- conscious clear and no psychosis
- literate and can communicate
- willing to participate and sign informed consent
Who cannot join
- Not volunteer
- subject felt weak or uncomfortable and patients decision to withdraw from the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University WanFang Hospital
Taipei, No.111, Section 3, Hsing-Long Rd, Taipei
Tso-Hsiao Chen, Dean, 02-29307930 ext. 8117, tsohsiao@tmu.edu.tw
About this study
Official title: The Study Will Investigate the Quality of Life in PD or HD Patients
Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis and hemodialysis related issues. There is no study related to establish the predictive model of quality of life. This study will investigate the predictive model of quality of life in terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer the further evidence to the government to develop the effective interventions for dialysis patients. The optimal goal is to promote the quality care.
- Conditions
- Peritoneal Dialysis, Hemodialysis
- Keywords
- peritoneal dialysis, hemodialysis patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| peritoneal dialysis and hemodialysis patients | peritoneal dialysis and hemodialysis patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startSep 2010
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tso-Hsiao Chen, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195519
- Sponsor's protocol ID
- 99039
- Status last verified
- Apr 2011
- First submitted
- 3 Sep 2010
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study Will Investigate the Quality of Life in PD or HD Patients
- ClinicalTrials.gov ID
- NCT01195519
- Acronym / sponsor ID
- 99039
- Conditions
- Peritoneal Dialysis, Hemodialysis
- Keywords
- peritoneal dialysis, hemodialysis patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Study completion
- Sep 2011 (estimated)
- First posted
- 6 Sep 2010 (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.
Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis and hemodialysis related issues. There is no study related to establish the predictive model of quality of life. This study will investigate the predictive model of quality of life in terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer the further evidence to the government to develop the effective interventions for dialysis patients. The optimal goal is to promote the quality care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peritoneal dialysis and hemodialysis patients | – | –peritoneal dialysis and hemodialysis patients |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- peritoneal dialysis and hemodialysis patients
Key inclusion criteria (4 listed)
- above 20 years old PD or HD patients
- conscious clear and no psychosis
- literate and can communicate
- willing to participate and sign informed consent
Key exclusion criteria (2 listed)
- Not volunteer
- subject felt weak or uncomfortable and patients decision to withdraw from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
- Click here for more information about this studyLink provided by the sponsor.
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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.
Tso-Hsiao Chen principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis and Hemodialysis, run by Taipei Medical University WanFang 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 4 inclusion and 2 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 26 Apr 2011. 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 Wan Fang, hospital (02-29307930 ext. 8117, huiyi072@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 26 Apr 2011.