Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000313932
Ethics application status
Approved
Date submitted
3/03/2011
Date registered
24/03/2011
Date last updated
13/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An exploratory study to determine the effectiveness of a chronic kidney disease (CKD) nurse working with general practitioners (GP) versus usual care with nephrologists in the comprehensive care of stable Stage 3-4 CKD patients in the Eastern Health Integrated Renal Service
Scientific title
Chronic kidney disease (CKD) patient outcomes from a CKD nurse led clinic versus usual care nephrologist clinic
Secondary ID [1] 259720 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 261298 0
Condition category
Condition code
Renal and Urogenital 259446 259446 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Currently stage 3-4 CKD patients attend a renal clinic to see a nephrologist every 3-4 months. Patients allocated to the intervention group will attend a renal clinic and be seen by a CKD nurse. The clinic will be held at the same time as the current renal clinic and enrolled patients will be seen one on one by a CKD nurse. Each clinic visit will take 30minutes. Patients will be seen by the CKD nurse once every 3-4months for a period of 2 years.
Intervention code [1] 264145 0
Treatment: Other
Comparator / control treatment
Comparator group will be patients who continue to attend the usual clinic run by a nephrologist.
Control group
Active

Outcomes
Primary outcome [1] 262252 0
The care of stable Stage 3-4 CKD patients reviewed every 3-4 months in a clinic run by a CKD nurse will not be inferior to the care of these patients having 3-4 monthly reviews with nephrologists.
Timepoint [1] 262252 0
2 years
Secondary outcome [1] 273399 0
Results of the Renal Quality of Life Questionnaire
Timepoint [1] 273399 0
Baseline, 1 year and 2 year.

Eligibility
Key inclusion criteria
1) Male and female patients aged over 18 years
2) a) eGFR 25-59ml/min with decline in eGFR of no more than 10% per year over the last 2 years based on pathology results, if available
b) Patients aged >=75 years who are opting for conservative management (i.e. not for dialysis) with eGFR as low as 20ml/min can be included
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) rapidly deteriorating renal function such as patients with active vasculitis
2) pregnant patients
3) unable to give consent because of dementia or language barrier
4) active malignancy

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be seen by a member of the study group (usually their treating doctor who may be one of the researchers) who will explain the project to them. All potential participants will be provided with a copy of the patient information sheet and allowed sufficient time to consider the information and seek other advice. Potential participants will also be informed that they may choose not to participate in the study without this affecting their ongoing medical treatment. Participants will be informed that they may withdraw from the study at any time without prejudicing their usual medical care.
Allocating group: master randomisation list was created by an independent staff member not on the study team. Secure randomisation envelopes are then opened in numerical order once a patient has consented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2011
Actual
26/08/2011
Date of last participant enrolment
Anticipated
Actual
16/05/2014
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
60
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 3799 0
3128
Recruitment postcode(s) [2] 3800 0
3134
Recruitment postcode(s) [3] 3873 0
3156

Funding & Sponsors
Funding source category [1] 264600 0
Other Collaborative groups
Name [1] 264600 0
ANZSN-Amgen Quality Assurance Grant
Country [1] 264600 0
Australia
Primary sponsor type
Individual
Name
Dr Kathleen Kan
Address
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street
Box Hill Victoria 3128
Country
Australia
Secondary sponsor category [1] 263739 0
None
Name [1] 263739 0
Address [1] 263739 0
Country [1] 263739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260598 0
Eastern Health Research and Ethics
Ethics committee address [1] 260598 0
Ethics committee country [1] 260598 0
Australia
Date submitted for ethics approval [1] 260598 0
21/02/2011
Approval date [1] 260598 0
19/05/2011
Ethics approval number [1] 260598 0
LR56/1011

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

Contacts
Principal investigator
Name 32301 0
Dr Dr Kathleen Kan
Address 32301 0
Eastern Health Integrated Renal Service Level 2, 5 Arnold Street Box Hill Victoria 3128
Country 32301 0
Australia
Phone 32301 0
61 3 9091 8872
Fax 32301 0
+61 3 9899 6810
Email 32301 0
kathleen.kan@easternhealth.org.au
Contact person for public queries
Name 15548 0
Annette Kent
Address 15548 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street
Box Hill Victoria 3128
Country 15548 0
Australia
Phone 15548 0
+61 3 9091 8871
Fax 15548 0
+ 61 3 9899 6810
Email 15548 0
annette.kent@easternhealth.org.au
Contact person for scientific queries
Name 6476 0
Dr Kathleen Kan
Address 6476 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street
Box Hill Victoria 3128
Country 6476 0
Australia
Phone 6476 0
+ 61 3 9097 8872
Fax 6476 0
+ 61 3 9899 6810
Email 6476 0
kathleen.kan@easternhealth.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.