Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000112662
Ethics application status
Approved
Date submitted
22/01/2014
Date registered
29/01/2014
Date last updated
29/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Helping Older Patients with End-stage kidney disease: survival, symptom control and quality of life without dialysis
Scientific title
Experiences of Palliative Nephrology and Pre-Dialysis Clinics (EXPAND): survival, symptom control and quality of life of patients not planned for dialysis who are receiving renal supportive care.
Secondary ID [1] 283962 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
EXPAND: HOPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 290992 0
Condition category
Condition code
Renal and Urogenital 291337 291337 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We sought to learn prospectively the likely survival of patients not planned for dialysis and whether or not they could be provided with reasonable quality of life and control of their symptoms.
This prospective observational study was over 4 years.
Intervention code [1] 288650 0
Not applicable
Comparator / control treatment
The comparator being studied are the outcomes of patients attending the Renal Supportive Care (RSC) clinic.
These outcomes will be compared to the patients attending standard renal clinics (Pre-Dialysis clinic).
Control group
Active

Outcomes
Primary outcome [1] 291325 0
Survival - time to death, or renal replacement therapy
Timepoint [1] 291325 0
Monitored over the 4 year study period
Primary outcome [2] 291326 0
Maintenance or improvement of symptoms. Symptoms were assessed using the Memorial Symptom Assessment Scale (MSAS-SF), a validated tool for assessing patients’ symptoms, as well as by using the POS-S (renal) survey for those patient in the Renal Supportive Care non-dialysis group. Symptoms were assessed as both the number of symptoms and the total symptom score.
Estimated glomerular filtration rate (eGFR) was repeated each 6 months along with repeat assessment of symptom burden by the MSAS-SF survey tool.
Timepoint [2] 291326 0
Monitored over the 4 year study period and recorded at 6 monthly intervals for each patient.
Primary outcome [3] 291327 0
Maintenance or improvement of quality of life.
Quality of life was assessed using the Short Form-36 (SF-36). Estimated glomerular filtration rate (eGFR) was repeated each 6 months along with repeat assessment of quality of life by the SF-36 survey tool.
Timepoint [3] 291327 0
Monitored over the 4 year study period and recorded at 6 monthly intervals for each patient.
Secondary outcome [1] 306531 0
Secondary outcomes included hospitalisations. This involves data linkage to patient medical records.
Timepoint [1] 306531 0
Monitored over the 4 year study period for each patient

Eligibility
Key inclusion criteria
Inclusion criteria were patients referred to either pre-dialysis clinic or the Renal Supportive Care clinic over 18 years with ability 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
Excluded were those patients planned for pre-emptive transplantation and patients who moved out of the area.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The number of participants needed to achieve the study objectives was based on patients attending the clinics within the 4 year study period. All patients, who consented, were included if they satisfied the inclusion criteria during this period.
Comparison of continuous variables between groups was done using Student's t-tests or Mann-Whitney tests as appropriate. Comparison of categorical variables between groups was done using Chi-square testing. Survival was estimated by the Kaplan-Meier technique from the initial visit to the relevant clinic and from the time eGFR fell below 15ml/min. Factors influencing survival were determined by multivariable logistic regression analysis. Factors tested in the univariable analysis included age, weight, eGFR at initial visit, BMI, Haemoglobin, serum albumin, Calcium, Phosphate, PTH, gender, diabetes, dementia, co-morbidities, smoking and nutritional status. All factors significant on univariable analysis were tested by step-wise multivariable analysis. Change in symptoms or QOL over time were categorized into "stable", "improved" or "worse". Chi-square testing was used to compare the change in symptoms and QOL between groups. Analysis was by intention to treat and level of significance was 0.05. Analyses were undertaken using SAS statistical software version 9.2.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2009
Actual
3/03/2009
Date of last participant enrolment
Anticipated
31/03/2009
Actual
27/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1992 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 7717 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 288595 0
Commercial sector/Industry
Name [1] 288595 0
Amgen Australia
Country [1] 288595 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Renal Department
50 Montgomery St
Kogarah
NSW 2217
Country
Australia
Secondary sponsor category [1] 287306 0
Commercial sector/Industry
Name [1] 287306 0
Amgen Australia
Address [1] 287306 0
Level 7
123 Epping Rd
North Ryde
NSW 2113
Country [1] 287306 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290459 0
South Eastern Sydney Local Health District- Northern Sector (SESLHD-NS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 290459 0
Research Support Office
South Eastern Sydney Local Health District
Prince of Wales Hospital
G71 East Wing, Edmund Blacket Building
Cnr High & Avoca Streets
Randwick
NSW 2031
Ethics committee country [1] 290459 0
Australia
Date submitted for ethics approval [1] 290459 0
03/09/2010
Approval date [1] 290459 0
29/09/2010
Ethics approval number [1] 290459 0
HREC/10/STG/121

Summary
Brief summary
A combined palliative and nephrology, Renal Supportive Care clinic was established in March 2009. This research aims to describe the impact of a specialised palliative nephrology service on outcomes and will put this in context by also describing outcomes of patients who are managed in standard renal clinics (pre-dialysis clinic).
The data collected is collected as part of standard medical care.
Trial website
Nil
Trial related presentations / publications
Presentation title: Non-dialysis management in the elderly: survival, symptom control and quality of life
Presenter: Professor Mark Brown
Conference: American Society of Nephrology (ASN), Kidney Week 2013, November 2013
Public notes
The number of participants needed to achieve the study objectives was determined by how many patients attended the clinics during the 4 year study period.
There were no statistical assumptions or any sample size calculations prior to commencing the study, therefore the number was determined by the number of clinic patients.

The data collection period commenced 3/3/2009, which was when the Renal Supportive Care clinic commenced. The decision to monitor and assess the outcomes of the clinic and compare them to the standard renal clinics was made in September 2010. The study was approved and the study was initially a retrospective observational study, then became a prospective study to capture patients attending the clinics until the conclusion of the study period in March 2013.

Contacts
Principal investigator
Name 45794 0
Prof Mark Brown
Address 45794 0
Renal Department
St George Hospital
50 Montgomery St
Kogarah
NSW 2217
Country 45794 0
Australia
Phone 45794 0
+610291132622
Fax 45794 0
+610295538192
Email 45794 0
[email protected]
Contact person for public queries
Name 45795 0
Prof Mark Brown
Address 45795 0
Renal Department
St George Hospital
50 Montgomery St
Kogarah
NSW 2217
Country 45795 0
Australia
Phone 45795 0
+610291132622
Fax 45795 0
+610295538192
Email 45795 0
[email protected]
Contact person for scientific queries
Name 45796 0
Ms Gemma Collett
Address 45796 0
Renal Department
St George Hospital
50 Montgomery St
Kogarah
NSW 2217
Country 45796 0
Australia
Phone 45796 0
+610291132854
Fax 45796 0
+610291132684
Email 45796 0
[email protected]

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
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