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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03816111




Registration number
NCT03816111
Ethics application status
Date submitted
12/12/2018
Date registered
25/01/2019

Titles & IDs
Public title
Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial
Scientific 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
Secondary ID [1] 0 0
AKTN 17.03
Universal Trial Number (UTN)
Trial acronym
TEACH-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease, Chronic 0 0
Peritoneal Dialysis Catheter-Associated Peritonitis 0 0
Peritoneal Dialysis Catheter Exit Site Infection 0 0
Peritoneal Dialysis Catheter Tunnel Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - TEACH-PD Training Curriculum
BEHAVIORAL - Current standard PD training

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

Active comparator: Current Standard PD Training - All patients at sites randomized to this arm will receive the unit's current PD training materials and plan


BEHAVIORAL: TEACH-PD Training Curriculum
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.

BEHAVIORAL: Current standard PD training
Current PD training materials and plan
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to the first occurrence of any PD-related infection
Timepoint [1] 0 0
From the PD start date until first PD-related infection, assessed up to 4 years
Secondary outcome [1] 0 0
Time to first exit site infection
Timepoint [1] 0 0
From the PD start date until first exit site infection, assessed up to 4 years
Secondary outcome [2] 0 0
Time to first tunnel infection
Timepoint [2] 0 0
From the PD start date until first tunnel infection, assessed up to 4 years
Secondary outcome [3] 0 0
Time to first episode of peritonitis
Timepoint [3] 0 0
From the PD start date until first peritonitis episode, assessed up to 4 years
Secondary outcome [4] 0 0
Time to infection-associated catheter removal
Timepoint [4] 0 0
From the PD start date until first infection-associated catheter removal, assessed up to 4 years
Secondary outcome [5] 0 0
Incidence of technique failure - 30 days
Timepoint [5] 0 0
Assessed at 30 days after transfer to HD or if death occurs within this period
Secondary outcome [6] 0 0
Incidence of technique failure - 180 days
Timepoint [6] 0 0
Assessed at 180 days after transfer to HD or if death occurs within this period
Secondary outcome [7] 0 0
Incidence of all-cause hospitalization
Timepoint [7] 0 0
Assessed from the PD start date, over up to 4 years
Secondary outcome [8] 0 0
Incidence of all-cause mortality
Timepoint [8] 0 0
Assessed from the PD start date, over up to 4 years
Secondary outcome [9] 0 0
Participant Quality of Life questionnaire
Timepoint [9] 0 0
Completed at baseline, 6, 12, 18 and 24 months
Secondary outcome [10] 0 0
Health-care cost-effectiveness analysis
Timepoint [10] 0 0
Assessed from the PD start date, over up to 4 years

Eligibility
Key inclusion criteria
* Patients new to PD;
* Patients > 18 years of age,
* Need to undergo PD training;
* Are able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Lismore Hospital - Lismore
Recruitment hospital [5] 0 0
Orange Hospital - Orange
Recruitment hospital [6] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [8] 0 0
Nepean/Blacktown Hospital - Sydney
Recruitment hospital [9] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [10] 0 0
Royal Prince Alfred/Concord Hospital - Sydney
Recruitment hospital [11] 0 0
St George Hospital - Sydney
Recruitment hospital [12] 0 0
Tamworth Hospital - Tamworth
Recruitment hospital [13] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [14] 0 0
Royal Darwin Hospital - Darwin
Recruitment hospital [15] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [16] 0 0
Cairns Hospital - Cairns
Recruitment hospital [17] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [18] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [19] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [20] 0 0
Sunshine Coast University Hospital - Nambour
Recruitment hospital [21] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [22] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [23] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [24] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [25] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [26] 0 0
Monash Health - Dandenong
Recruitment hospital [27] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [28] 0 0
Barwon Health - Geelong
Recruitment hospital [29] 0 0
Austin Health - Heidelberg
Recruitment hospital [30] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [31] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [32] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [33] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Lismore
Recruitment postcode(s) [5] 0 0
- Orange
Recruitment postcode(s) [6] 0 0
- St Leonards
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
- Tamworth
Recruitment postcode(s) [9] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [10] 0 0
0810 - Darwin
Recruitment postcode(s) [11] 0 0
- Brisbane
Recruitment postcode(s) [12] 0 0
- Cairns
Recruitment postcode(s) [13] 0 0
4029 - Herston
Recruitment postcode(s) [14] 0 0
4740 - Mackay
Recruitment postcode(s) [15] 0 0
- Meadowbrook
Recruitment postcode(s) [16] 0 0
- Nambour
Recruitment postcode(s) [17] 0 0
- Southport
Recruitment postcode(s) [18] 0 0
- Toowoomba
Recruitment postcode(s) [19] 0 0
- Adelaide
Recruitment postcode(s) [20] 0 0
7000 - Hobart
Recruitment postcode(s) [21] 0 0
7250 - Launceston
Recruitment postcode(s) [22] 0 0
- Dandenong
Recruitment postcode(s) [23] 0 0
3065 - Fitzroy
Recruitment postcode(s) [24] 0 0
3220 - Geelong
Recruitment postcode(s) [25] 0 0
- Heidelberg
Recruitment postcode(s) [26] 0 0
- Melbourne
Recruitment postcode(s) [27] 0 0
6150 - Murdoch
Recruitment postcode(s) [28] 0 0
6009 - Nedlands
Recruitment postcode(s) [29] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Blenheim
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Dunedin
Country [5] 0 0
New Zealand
State/province [5] 0 0
Gisborne
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton
Country [7] 0 0
New Zealand
State/province [7] 0 0
Hastings
Country [8] 0 0
New Zealand
State/province [8] 0 0
Nelson
Country [9] 0 0
New Zealand
State/province [9] 0 0
New Plymouth
Country [10] 0 0
New Zealand
State/province [10] 0 0
Palmerston North
Country [11] 0 0
New Zealand
State/province [11] 0 0
Wellington
Country [12] 0 0
New Zealand
State/province [12] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The HOME Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australia and New Zealand Dialysis and Transplant Registry
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
New Zealand Peritoneal Dialysis Registry
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil C Boudville, Prof
Address 0 0
University of Western Australia & Sir Charles Gairdner Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03816111