NCT03816111|CompletedDMC

Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial

TEACH-PD

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

The University of Queensland ClinicalTrials.gov

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1 other identifier

AKTN 17.03

Study Type

interventional

Target

1,462

Locations

2 countries

Sites

Timeline

RegisteredJan 2019

StartedJul 2019

CompletionApr 2025

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,462

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach

2 countries

48 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.8 years study duration

First Submitted

Initial submission to the registry

December 12, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed

6 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

December 12, 2018

Last Update Submit

March 26, 2026

Conditions

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

Keywords

Training

Outcome Measures

Primary Outcomes (1)

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
From the PD start date until first PD-related infection, assessed up to 4 years

Secondary Outcomes (10)

Time to first exit site infection
From the PD start date until first exit site infection, assessed up to 4 years
Time to first tunnel infection
From the PD start date until first tunnel infection, assessed up to 4 years
Time to first episode of peritonitis
From the PD start date until first peritonitis episode, assessed up to 4 years
Time to infection-associated catheter removal
From the PD start date until first infection-associated catheter removal, assessed up to 4 years
Incidence of technique failure - 30 days
Assessed at 30 days after transfer to HD or if death occurs within this period
+5 more secondary outcomes

Other Outcomes (1)

Life participation questionnaire
Completed at baseline and 24 months

Study Arms (2)

TEACH-PD Training Curriculum

EXPERIMENTAL

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

Behavioral: TEACH-PD Training Curriculum

Current Standard PD Training

ACTIVE COMPARATOR

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

Behavioral: Current standard PD training

Interventions

TEACH-PD Training CurriculumBEHAVIORAL

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.

TEACH-PD Training Curriculum

Current standard PD trainingBEHAVIORAL

Current PD training materials and plan

Current Standard PD Training

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

The University of Queenslandlead
The HOME Networkcollaborator
Australia and New Zealand Dialysis and Transplant Registrycollaborator
New Zealand Peritoneal Dialysis Registrycollaborator

Study Sites (48)

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Gosford Hospital

Gosford, New South Wales, Australia

Location

Lismore Hospital

Lismore, New South Wales, Australia

Location

Orange Hospital

Orange, New South Wales, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Location

Liverpool Hospital