Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000024943
Ethics application status
Approved
Date submitted
3/01/2011
Date registered
7/01/2011
Date last updated
4/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Dialysis outcomes in those aged 65 years or over.
Scientific title
Health and quality of life for people with kidney disease aged over 65 years.
Secondary ID [1] 253337 0
None
Universal Trial Number (UTN)
Trial acronym
DOS65+
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study is a comprehensive prospective longitudinal survey of health-related quality of life (HRQOL) outcomes, linked to survival, for individuals aged 65 years or over, either on, or eligible for, dialysis therapy. 258876 0
Condition category
Condition code
Renal and Urogenital 259017 259017 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A 3 year prospective longitudinal observational survey of health-related quality of life (HRQOL) outcomes for individuals aged 65 years or older on, or eligible for, dialysis therapy linked to survival outcomes.
Data collected by yearly one-on-one structured interviews with participants by trained health care interviewers either face to face or by telephone.
Data collected by yearly structured interviews with participants will be linked to co-morbidity data, health service use, and laboratory information collected from health records, and analysed with respect to survival.
In parallel, a qualitative project with 20 participants from the main study will be undertaken. Qualitative interviews will undertaken by trained health care professionals.
Intervention code [1] 257789 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259870 0
Short term impact. Quantitative baseline HRQoL and the impact of: age, sex, ethnicity, duration of dialysis and comorbidity on HRQoL from the Cross-Sectional Study. These results will provide a valuable baseline source of data for health workers in this area.
Timepoint [1] 259870 0
It is expected that the cross-sectional study will be completed, analysed and published before the end of the second year of the project.
Primary outcome [2] 259871 0
Longer term impact. Determination of factors bringing about changes in HRQoL impacting on survival from participants in the Accelerated Longitudinal Study will take a longer time to collate and publish the data. Completion of the data should be towards the end of the 3rd year.
Timepoint [2] 259871 0
Time points for interviews will be yearly for 3 years to assess longer term impact.
Secondary outcome [1] 268748 0
Nil
Timepoint [1] 268748 0
Nil

Eligibility
Key inclusion criteria
1) Prevalent dialysis patients aged 65 years or over, who have been on dialysis for 90 days prior to survey date will be eligible to participate in the study.
2) Incident (new) chronic kidney disease patients aged 65 years or over, with an eGFR equal to or less than 15 ml/min/1.73m2 presenting to the same services for consideration of dialysis will be eligible to participate in the study. A proportion of these incident patients will decide not to undertake dialysis. They will provide important data to compare and contrast with those who commence dialysis. At present, no data are collected in New Zealand about proportion of patients who decide not to enter a dialysis programme for end stage renal failure, although we estimate this to be 10 of the 40 incident patients recruited to the study each year. 3) Patients aged =65 years who present with hitherto unrecognized renal failure requiring immediate dialysis will be eligible if their renal failure is deemed permanent by the treating nephrologist, and if dialysis is intended to be an indefinite treatment.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to give informed consent, 2) Inability to participate in a telephone or face-to-face interview 3) Intercurrent illness requiring hospitalisation (current and within 2 weeks of the survey period) and of sufficient severity to affect patient’s ability to take part in the opinion of the treating physician (interviews for this last group will be rescheduled for 1 month later).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2011
Actual
17/01/2011
Date of last participant enrolment
Anticipated
Actual
6/07/2015
Date of last data collection
Anticipated
Actual
12/07/2016
Sample size
Target
292
Accrual to date
Final
225
Recruitment outside Australia
Country [1] 3116 0
New Zealand
State/province [1] 3116 0

Funding & Sponsors
Funding source category [1] 258260 0
Government body
Name [1] 258260 0
Health Research Council of New Zealand
Country [1] 258260 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 257425 0
None
Name [1] 257425 0
Address [1] 257425 0
Country [1] 257425 0
Other collaborator category [1] 251751 0
Hospital
Name [1] 251751 0
Southern District Health Board
Address [1] 251751 0
Southern DHB
Private Bag 1921
Dunedin 9054
New Zealand
Country [1] 251751 0
New Zealand
Other collaborator category [2] 251752 0
Hospital
Name [2] 251752 0
Counties Manukau District Health Board
Address [2] 251752 0
Private Bag 94052
South Auckland Mail Centre
Manukau 2240
Country [2] 251752 0
New Zealand
Other collaborator category [3] 251753 0
Hospital
Name [3] 251753 0
Hawes Bay District Health Board
Address [3] 251753 0
Omahu Road
Private Bag 9014
Hastings 4156
Country [3] 251753 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260235 0
Multi-region Ethics Committee
Ethics committee address [1] 260235 0
Multi-region Ethics Committee
Ministry of Health
10th Floor 180 Molesworth Street
PO Box 5013
Wellington. 6145
Ethics committee country [1] 260235 0
New Zealand
Date submitted for ethics approval [1] 260235 0
Approval date [1] 260235 0
01/11/2010
Ethics approval number [1] 260235 0
MEC/10/08/084

Summary
Brief summary
This project addresses a key area of older adults’ medical care. In New Zealand and internationally, the proportion of older people with CKD in rising rapidly, with the resultant increase in costly renal replacement therapy (RRT) ($65 - $80,000/year/person). Assumptions are made that dialysis is appropriate for all individuals; this may not be valid. Older patients who do not commence dialysis often survive many months and some may have a better quality of life (HRQoL) than those on dialysis. The aim of this project is to obtain sufficient HRQoL data to inform clinicians’ and patients’ decision-making with respect to dialysis in New Zealand.
The Health of Older People strategy (MOH 2002) states older people with high and complex health and disability support needs, need access to flexible, timely and co-ordinated services and living options that take account of family/whanau carer needs. Determinants of successful dialysis in older people are multifactorial, including –degree of autonomy or control related to managing dialysis, associated co-morbidity and socio-economic factors and the aging process. The impact of these factors on outcome and HRQoL for the individual and their family/whanau is largely unknown.
HRQoL is determined, not only by the disease process itself, but also by the individual’s physical and mental state, as well as the availability of support from family and community. This project will address the relevance, timeliness, and sustainability of dialysis in the older age group. Information about dialysis choices among this age group, related to their expectations and HRQoL, will iinfluence delivery of healthcare. This multi-disciplinary project will provide essential data immediately relevant to decision-making by the clinical team, the individual patient and the patient’s family/whanau. It is vital for future health care delivery of renal replacement therapy for those aged 65 years or over in New Zealand that reliable data are obtained.
Trial website
Not available yet
Trial related presentations / publications
Dialysis outcomes in those aged =65 years Robert Walker*, Sarah Derrett, John Campbell, Mark R Marshall, Andrew Henderson, John Schollum, Sheila Williams and Bronwen McNoe.
BMC Nephrology 2013, 14:175 http://www.biomedcentral.com/1471-2369/14/175.

Lovell S, Walker RJ, Schollum JBW, et al. To dialyse or delay: a qualitative study of older New Zealanders’ perceptions and experiences of decisionmaking with stage 5 chronic kidney disease. BMJ Open 2017;7:e014781. doi:10.1136/bmjopen-2016-014781
Public notes

Contacts
Principal investigator
Name 32047 0
Prof Robert Walker
Address 32047 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin
New Zealand 9054
Country 32047 0
New Zealand
Phone 32047 0
+64 34740999
Fax 32047 0
Email 32047 0
rob.walker@otago.ac.nz
Contact person for public queries
Name 15294 0
Prof Prof Robert Walker
Address 15294 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country 15294 0
New Zealand
Phone 15294 0
+64 3 4740999 ex 8045
Fax 15294 0
+64 3 4747641
Email 15294 0
rob.walker@otago.ac.nz
Contact person for scientific queries
Name 6222 0
Prof Prof Robert Walker
Address 6222 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054
Country 6222 0
New Zealand
Phone 6222 0
+64 3 4740999 ex 8045
Fax 6222 0
+64 3 4747641
Email 6222 0
rob.walker@otago.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseHealth-Related Quality of Life and Disability Among Older New Zealanders With Kidney Failure: A Prospective Study.2022https://dx.doi.org/10.1177/20543581221094712
EmbasePredictors of Health Deterioration among Older New Zealanders after Twelve Months of Dialysis Therapy: Provisional Findings.2016
EmbaseTo dialyse or delay: A qualitative study of older New Zealanders' perceptions and experiences of decision-making, with stage 5 chronic kidney disease.2017https://dx.doi.org/10.1136/bmjopen-2016-014781
N.B. These documents automatically identified may not have been verified by the study sponsor.