ANZCTR - Registration

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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]

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.

Condition category

Condition code

Renal and Urogenital

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

Time points for interviews will be yearly for 3 years to assess longer term impact.

Secondary outcome [1]

Nil

Timepoint [1]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 56
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Southern District Health Board

Address [1]

Southern DHB
Private Bag 1921
Dunedin 9054
New Zealand

Country [1]

New Zealand

Other collaborator category [2]

Hospital

Name [2]

Counties Manukau District Health Board

Address [2]

Private Bag 94052
South Auckland Mail Centre
Manukau 2240

Country [2]

New Zealand

Other collaborator category [3]

Hospital

Name [3]

Hawes Bay District Health Board

Address [3]

Omahu Road
Private Bag 9014
Hastings 4156

Country [3]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Multi-region Ethics Committee

Ethics committee address [1]

Multi-region Ethics Committee
Ministry of Health
10th Floor 180 Molesworth Street 
PO Box 5013
Wellington. 6145

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

01/11/2010

Ethics approval number [1]

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

Prof Robert Walker

Address

Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin
New Zealand 9054

Country

New Zealand

Phone

+64 34740999

Fax

rob.walker@otago.ac.nz

Contact person for public queries

Name

Prof Robert Walker

Address

Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054

Country

New Zealand

Phone

+64 3 4740999 ex 8045

Fax

+64 3 4747641

rob.walker@otago.ac.nz

Contact person for scientific queries

Name

Prof Robert Walker

Address

Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin 9054

Country

New Zealand

Phone

+64 3 4740999 ex 8045

Fax

+64 3 4747641

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

Source	Title	Year of Publication	DOI
Embase	Predictors of Health Deterioration among Older New Zealanders after Twelve Months of Dialysis Therapy: Provisional Findings.	2016
Embase	To dialyse or delay: A qualitative study of older New Zealanders' perceptions and experiences of decision-making, with stage 5 chronic kidney disease.	2017	https://dx.doi.org/10.1136/bmjopen-2016-014781
Embase	Health-Related Quality of Life and Disability Among Older New Zealanders With Kidney Failure: A Prospective Study.	2022	https://dx.doi.org/10.1177/20543581221094712

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically