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Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial (TEACH-PD)

Primary Purpose

Kidney Disease, Chronic, Peritoneal Dialysis Catheter-Associated Peritonitis, Peritoneal Dialysis Catheter Exit Site Infection

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TEACH-PD Training Curriculum
Current standard PD training
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Disease, Chronic focused on measuring Training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients new to PD;
  • Patients > 18 years of age,
  • Need to undergo PD training;
  • Are able to provide informed consent

Sites / Locations

  • Canberra HospitalRecruiting
  • St Vincent's Hospital SydneyRecruiting
  • Gosford HospitalRecruiting
  • Lismore HospitalRecruiting
  • Orange HospitalRecruiting
  • Royal North Shore HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Nepean/Blacktown HospitalRecruiting
  • Prince of Wales HospitalRecruiting
  • Royal Prince Alfred/Concord HospitalRecruiting
  • St George HospitalRecruiting
  • Tamworth HospitalRecruiting
  • The Tweed HospitalRecruiting
  • Royal Darwin HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Cairns HospitalRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Mackay Base HospitalRecruiting
  • Logan HospitalRecruiting
  • Sunshine Coast University HospitalRecruiting
  • Gold Coast University HospitalRecruiting
  • Toowoomba HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Royal Hobart HospitalRecruiting
  • Launceston General HospitalRecruiting
  • Monash HealthRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • Barwon HealthRecruiting
  • Austin HealthRecruiting
  • Royal Melbourne HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • Sir Charles Gairdner HospitalRecruiting
  • Royal Perth HospitalRecruiting
  • Waitakere HospitalRecruiting
  • North Shore HospitalRecruiting
  • Auckland HospitalRecruiting
  • Middlemore HospitalRecruiting
  • Wairau HospitalRecruiting
  • Christchurch HospitalRecruiting
  • Dunedin HospitalRecruiting
  • Gisborne HospitalRecruiting
  • Waikato HospitalRecruiting
  • Hawke's Bay HospitalRecruiting
  • Nelson HospitalRecruiting
  • Taranaki HospitalRecruiting
  • Palmerston North/Whanganui HospitalRecruiting
  • Wellington HospitalRecruiting
  • Whangarei HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEACH-PD Training Curriculum

Current Standard PD Training

Arm Description

All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum

All patients at sites randomized to this arm will receive the unit's current PD training materials and plan

Outcomes

Primary Outcome Measures

Time to the first occurrence of any PD-related infection
Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis

Secondary Outcome Measures

Time to first exit site infection
Time to first exit site infection
Time to first tunnel infection
Time to first tunnel infection
Time to first episode of peritonitis
Time to first episode of peritonitis
Time to infection-associated catheter removal
Time to infection-associated catheter removal
Incidence of technique failure - 30 days
Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time
Incidence of technique failure - 180 days
Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time
Incidence of all-cause hospitalization
Incidence of all-cause hospitalization collected via health department hospitalization data linkage
Incidence of all-cause mortality
Incidence of all-cause mortality
Participant Quality of Life questionnaire
Participant-reported Quality of Life measured using EQ-5D-5L (EuroQol-5 dimensions questionnaire). EQ-5D-5L measures quality of life using 2 methods - a descriptive scale and a Visual Analogue Scale. The descriptive scale comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/ depression). Each dimension has 5 measurement levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Numbers associated with levels can be used to report an index score. The VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Health-care cost-effectiveness analysis
Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms

Full Information

First Posted
December 12, 2018
Last Updated
August 3, 2022
Sponsor
The University of Queensland
Collaborators
The HOME Network, Australia and New Zealand Dialysis and Transplant Registry, New Zealand Peritoneal Dialysis Registry
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1. Study Identification

Unique Protocol Identification Number
NCT03816111
Brief Title
Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial
Acronym
TEACH-PD
Official Title
A Pragmatic, Registry-based, International, Cluster-randomized Controlled Trial Examining the Use of TEACH-PD Training Modules for Incident PD Patients Versus Existing Practices on the Rate of PD-related Infections
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
The HOME Network, Australia and New Zealand Dialysis and Transplant Registry, New Zealand Peritoneal Dialysis Registry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
For many patients peritoneal dialysis (PD) is the preferred form of dialysis to treat kidney disease as it provides greater flexibility and the ability to dialyse at home. However, PD use in Australia has been decreasing over the last 10 years. A big reason for this drop is the risk of infection. The best way to prevent PD related infections is to make sure that patients have good training in PD techniques. The researchers of this study have developed TEACH-PD, a new education package for training both PD nurses and PD patients. The aim of this study is to find out whether TEACH-PD training reduces the number of PD related infections.
Detailed Description
End stage kidney disease is fatal unless treated with dialysis or transplant. Peritoneal dialysis (PD) is a core dialysis modality offering home-based care for patients. PD utilization is frequently threatened beyond 5 years for most patients due to PD-related infections. Patient training is a critical cornerstone of mitigating infection risk and maximizing PD durability (technique survival), but training practices are characterized by a lack of standardization and severe heterogeneity. There is no high-level evidence to inform PD training. Accordingly, a structured program encompassing how and what to teach PD patients at the inception of PD treatment has the potential to reduce serious PD-related infections, extend the longevity of PD, support cost-effective home-based dialysis care, and reduce costs and health service utilization associated with hospitalization and transition to haemodialysis. TEACH-PD is a standardised modular curriculum for both PD nurse trainers and patients that has been collaboratively developed by renal nurses, doctors, educationalists and patients, aligned to current International Society for Peritoneal Dialysis (ISPD) guidelines, utilizing modern adult learning principles. The TEACH-PD program is feasible and acceptable, as demonstrated in a successful pilot study. The primary objective of TEACH-PD CRCT (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes - a Cluster Randomised Controlled Trial) is to determine whether implementation of standardised training modules based on ISPD guidelines targeting both PD trainers and patients results in a longer time to the composite end-point of exit site infections, tunnel infections and peritonitis in incident PD patients compared to existing training practices. TEACH-PD is a registry-based, pragmatic, multi-center, multinational trial, randomising PD units to implementing TEACH-PD training modules targeted at PD trainers and incident PD patients versus standard existing practices. An estimated 1,500 patient new to PD will be recruited from at least approximately 42-44 PD units in Australia and New Zealand.The study is being coordinated by the University of Queensland (operating through the Australasian Kidney Trial Network). The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the ISPD guidelines, utilizing modern adult learning principles and best practice eLearning techniques. The modules will be implemented at PD units in Australia and New Zealand to formally evaluate whether, compared with standard care, a standardised training curriculum will reduce the rate of PD-related infections and improve technique survival, resulting in better outcomes for patients receiving PD and significant cost-savings to the community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Chronic, Peritoneal Dialysis Catheter-Associated Peritonitis, Peritoneal Dialysis Catheter Exit Site Infection, Peritoneal Dialysis Catheter Tunnel Infection
Keywords
Training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEACH-PD Training Curriculum
Arm Type
Experimental
Arm Description
All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum
Arm Title
Current Standard PD Training
Arm Type
Active Comparator
Arm Description
All patients at sites randomized to this arm will receive the unit's current PD training materials and plan
Intervention Type
Behavioral
Intervention Name(s)
TEACH-PD Training Curriculum
Intervention Description
The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the International Society for Peritoneal Dialysis guidelines, utilizing modern adult learning principles and best practice eLearning techniques.
Intervention Type
Behavioral
Intervention Name(s)
Current standard PD training
Intervention Description
Current PD training materials and plan
Primary Outcome Measure Information:
Title
Time to the first occurrence of any PD-related infection
Description
Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis
Time Frame
From the PD start date until first PD-related infection, assessed up to 4 years
Secondary Outcome Measure Information:
Title
Time to first exit site infection
Description
Time to first exit site infection
Time Frame
From the PD start date until first exit site infection, assessed up to 4 years
Title
Time to first tunnel infection
Description
Time to first tunnel infection
Time Frame
From the PD start date until first tunnel infection, assessed up to 4 years
Title
Time to first episode of peritonitis
Description
Time to first episode of peritonitis
Time Frame
From the PD start date until first peritonitis episode, assessed up to 4 years
Title
Time to infection-associated catheter removal
Description
Time to infection-associated catheter removal
Time Frame
From the PD start date until first infection-associated catheter removal, assessed up to 4 years
Title
Incidence of technique failure - 30 days
Description
Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time
Time Frame
Assessed at 30 days after transfer to HD or if death occurs within this period
Title
Incidence of technique failure - 180 days
Description
Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time
Time Frame
Assessed at 180 days after transfer to HD or if death occurs within this period
Title
Incidence of all-cause hospitalization
Description
Incidence of all-cause hospitalization collected via health department hospitalization data linkage
Time Frame
Assessed from the PD start date, over up to 4 years
Title
Incidence of all-cause mortality
Description
Incidence of all-cause mortality
Time Frame
Assessed from the PD start date, over up to 4 years
Title
Participant Quality of Life questionnaire
Description
Participant-reported Quality of Life measured using EQ-5D-5L (EuroQol-5 dimensions questionnaire). EQ-5D-5L measures quality of life using 2 methods - a descriptive scale and a Visual Analogue Scale. The descriptive scale comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/ depression). Each dimension has 5 measurement levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Numbers associated with levels can be used to report an index score. The VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Time Frame
Completed at baseline, 6, 12, 18 and 24 months
Title
Health-care cost-effectiveness analysis
Description
Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms
Time Frame
Assessed from the PD start date, over up to 4 years
Other Pre-specified Outcome Measures:
Title
Life participation questionnaire
Description
Life participation measured using PROMIS (patient-reported outcomes measurement information system) Short Form - Ability to participate in social roles and activities 6a. PROMIS will measure 6 dimensions (trouble with leisure activities, trouble doing family activities, trouble doing work, trouble doing activities with friends, limiting fun with others and limiting activities with friends). Each dimension has 5 measurement levels: Always (1), Usually, (2), Sometimes (3), Rarely (4) and Never (5).
Time Frame
Completed at baseline and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients new to PD; Patients > 18 years of age, Need to undergo PD training; Are able to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeoungjee Cho, PhD
Phone
+61 7 3176 2732
Email
Yeoungjee.Cho@health.qld.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Robison, BSc
Phone
+61 427911414
Email
teachpd@uq.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil C Boudville, Prof
Organizational Affiliation
University of Western Australia & Sir Charles Gairdner Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Josephine S Chow, Prof
Organizational Affiliation
South Western Sydney Local Health District
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yeoungjee Cho, PhD
Organizational Affiliation
Queensland Health/Princess Alexandra Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Singer
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Bexton
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Kemp
Facility Name
Lismore Hospital
City
Lismore
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjeev Baweja, MD
Facility Name
Orange Hospital
City
Orange
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Anderson
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Cooper
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Spicer
Facility Name
Nepean/Blacktown Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal Sud
Facility Name
Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Kelleher
Facility Name
Royal Prince Alfred/Concord Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Saunders
Facility Name
St George Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Cuesta
Facility Name
Tamworth Hospital
City
Tamworth
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen May
Facility Name
The Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Gosling
Phone
07 5506 7200
Email
Andrew.gosling@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Andrew Gosling
Facility Name
Royal Darwin Hospital
City
Darwin
State/Province
Northern Territory
ZIP/Postal Code
0810
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bidhun Paulose, MD
Phone
+61(0)889228888
Email
Bidhun.Paulose@nt.gov.au
First Name & Middle Initial & Last Name & Degree
Nadine Tinsley, RN
Phone
+61 8 89226485
Email
PeritonealDialysisCas.THS@nt.gov.au
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Johnson
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harris Hakim
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Wolley
Facility Name
Mackay Base Hospital
City
Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Cherian
Facility Name
Logan Hospital
City
Meadowbrook
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Tan
Facility Name
Sunshine Coast University Hospital
City
Nambour
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Nataatmadja
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murthy Divi
Facility Name
Toowoomba Hospital
City
Toowoomba
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alok Gupta
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen McDonald
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Jose
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew Mathew
Facility Name
Monash Health
City
Dandenong
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Brown
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Ierino
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Somerville
First Name & Middle Initial & Last Name & Degree
Rosie Simmonds
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Davies
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Moody
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramyasuda Swaminathan
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Boudville
Email
neil.boudville@uwa.edu.au
First Name & Middle Initial & Last Name & Degree
Neil Boudville
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greg Perry, Dr
Email
gregory.perry@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Greg Perry, Dr
Facility Name
Waitakere Hospital
City
Auckland
ZIP/Postal Code
0610
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad Maher
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad Maher
Facility Name
Auckland Hospital
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thu Nguyen
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Kendrick-Jones
Facility Name
Wairau Hospital
City
Blenheim
ZIP/Postal Code
7201
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Chembo
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Hill
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Putt
Facility Name
Gisborne Hospital
City
Gisborne
ZIP/Postal Code
4010
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddie Tan
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddie Tan
Facility Name
Hawke's Bay Hospital
City
Hastings
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Reynolds
Facility Name
Nelson Hospital
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Chembo
Facility Name
Taranaki Hospital
City
New Plymouth
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashik Hayat
Facility Name
Palmerston North/Whanganui Hospital
City
Palmerston North
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilyn Aday
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Chembo
Facility Name
Whangarei Hospital
City
Whangarei
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walaa Saweirs

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
IPD Sharing Time Frame
Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in the investigator's University's data warehouse but without investigator support other than deposited metadata.
IPD Sharing Access Criteria
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.

Learn more about this trial

Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial

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