The Assessment of Quality of Life in Patients With Perito... | NCT01195519

Studies
The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis

NCT01195519

Sponsor

Taipei Medical University WanFang Hospital

Status

Unknown status

Last Update Posted

Apr 26, 2011Estimated

Enrollment

95Estimated

Phase

Not provided

Conditions

Peritoneal Dialysis
Hemodialysis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Not provided

Completion Date

Sep 2011Estimated

First Submitted Date

Sep 3, 2010

First Submission Date that Met QC Criteria

Sep 3, 2010

First Posted Date

Sep 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2011

Last Update Posted Date

Apr 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
peritoneal dialysis and hemodialysis patients		peritoneal dialysis and hemodialysis patients

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above 20 years old PD or HD patients
conscious clear and no psychosis
literate and can communicate
willing to participate and sign informed consent

Exclusion Criteria:

Not volunteer
subject felt weak or uncomfortable and patients decision to withdraw from the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

peritoneal dialysis and hemodialysis patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wan Fang, hospital	Contact	02-29307930	8117	huiyi072@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Tso-Hsiao Chen	Taipei Medical University WanFang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University WanFang Hospital	Recruiting	Taipei	No.111, Section 3, Hsing-Long Rd, Taipei		Taiwan