Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000314527
Ethics application status
Approved
Date submitted
23/03/2015
Date registered
7/04/2015
Date last updated
23/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Home First Study: Patient and Caregiver Preferences for Home Dialysis.
Scientific title
Patient and caregivers identification of the key attributes between home and facility dialysis which contribute to the uptake of home dialysis.
Secondary ID [1] 286392 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease
 294541 0
Dialysis 294542 0
End stage kidney disease 294543 0
Condition category
Condition code
Renal and Urogenital 294850 294850 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
Key attributes which influence patient and caregivers decision to uptake home dialysis.
These attributes will be identified in qualitative interviews (1 interview approximately 60-90 minutes in duration)with patients and caregivers who have received formal education on dialysis modalities or who have commenced on dialysis within the last twelve months.
Discrete choice experiment surveys based on the results of the interviews will then be conducted to a group of approximately 150 patients and caregivers.
Intervention code [1] 291463 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294611 0
Key attributes which influence home dialysis uptake as assessed by Discrete Choice Experiment Survey in patients and caregivers. The Discrete Choice Experiment Survey will be designed specifically for this study based on the findings from the qualitative interviews.
Timepoint [1] 294611 0
At time of survey questionnaire
Secondary outcome [1] 313712 0
Nil
Timepoint [1] 313712 0
Nil

Eligibility
Key inclusion criteria
Patients or caregivers over 18 years old who are currently under the care of one of three renal units in New Zealand: Hawke's Bay, Counties Manukau or Capital and Coast District Health Boards who have either received formal pre-dialysis education (Pre-dialysis) or have commenced dialysis (facility or home haemodialysis or peritoneal dialysis) within the last twelve months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients or caregivers unable to provide informed consent.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2014
Actual
29/08/2014
Date of last participant enrolment
Anticipated
30/06/2016
Actual
1/07/2016
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
350
Accrual to date
Final
244
Recruitment outside Australia
Country [1] 6768 0
New Zealand
State/province [1] 6768 0

Funding & Sponsors
Funding source category [1] 290964 0
Charities/Societies/Foundations
Name [1] 290964 0
Lottery Health Research
Country [1] 290964 0
New Zealand
Funding source category [2] 290965 0
Commercial sector/Industry
Name [2] 290965 0
Baxter Healthcare Corporation
Country [2] 290965 0
United States of America
Primary sponsor type
University
Name
The University of Sydney
Address
New South Wales 2006
Country
Australia
Secondary sponsor category [1] 289645 0
None
Name [1] 289645 0
Address [1] 289645 0
Country [1] 289645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292561 0
Ko Awatea Research Office
Ethics committee address [1] 292561 0
Clinical Support Building
Room 253, Level 2
Counties Manukau DHB
100 Hospital Road
Otahuhu
Auckland 2025
Ethics committee country [1] 292561 0
New Zealand
Date submitted for ethics approval [1] 292561 0
Approval date [1] 292561 0
19/06/2014
Ethics approval number [1] 292561 0

Summary
Brief summary
The rates of chronic kidney disease are increasing rapidly. Home dialysis is believed to offer better survival, quality of life and is not as expensive as hospital dialysis. Despite this the rates of home dialysis are low and in some countries like NZ declining. This research explores patient and caregivers perceptions of what influences their decision about whether they choose home or hospital dialysis. We will firstly interview patients to determine these factors and then we will send surveys based on what we find in the patient and caregiver interview so we can determine what factors patients and caregivers are more influential in this decision making process.
Trial website
Trial related presentations / publications
i) Walker, R.C., Morton, R.L., Tong, A., Marshall, M.R., Palmer, S. and Howard, K., 2015. Patient and caregiver preferences for home dialysis—the home first study: a protocol for qualitative interviews and discrete choice experiments. BMJ open, 5(4), p.e007405.

ii) Walker, R.C., Howard, K., Morton, R.L., Palmer, S.C., Marshall, M.R. and Tong, A., 2015. Patient and caregiver values, beliefs and experiences when considering home dialysis as a treatment option: a semi-structured interview study. Nephrology Dialysis Transplantation, p.gfv330.

iii) Walker, R.C., Howard, K., Tong, A., Palmer, S.C., Marshall, M.R. and Morton, R.L., 2016. The economic considerations of patients and caregivers in choice of dialysis modality. Hemodialysis International, 20(4), pp.634-642.

iv) Walker, R.C., Walker, S., Morton, R.L., Tong, A., Howard, K. and Palmer, S.C., 2017. Maori patients' experiences and perspectives of chronic kidney disease: a New Zealand qualitative interview study. BMJ open, 7(1), p.e013829.
Public notes

Contacts
Principal investigator
Name 55754 0
Mrs Rachael Claire Walker
Address 55754 0
C/- Renal House,
HBDHB
Private Bag 9014
Hastings 4120
Country 55754 0
New Zealand
Phone 55754 0
+6468781631
Fax 55754 0
Email 55754 0
[email protected]
Contact person for public queries
Name 55755 0
Mrs Rachael Walker
Address 55755 0
C/- Renal House
HBDHB, Private Bag 9014
Hastings 4130
Country 55755 0
New Zealand
Phone 55755 0
+6468781631
Fax 55755 0
Email 55755 0
[email protected]
Contact person for scientific queries
Name 55756 0
Mrs Rachael Walker
Address 55756 0
C/- Renal House
HBDHB, Private Bag 9014
Hastings 4130
Country 55756 0
New Zealand
Phone 55756 0
+6468781631
Fax 55756 0
Email 55756 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
SourceTitleYear of PublicationDOI
EmbasePatient and caregiver preferences for home dialysis-The home first study: A protocol for qualitative interviews and discrete choice experiments.2015https://dx.doi.org/10.1136/bmjopen-2014-007405
N.B. These documents automatically identified may not have been verified by the study sponsor.