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Trial registered on ANZCTR
Registration number
ACTRN12618001976279
Ethics application status
Approved
Date submitted
5/12/2018
Date registered
7/12/2018
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Can Symptom monitoring With Feedback to clinicians improve the lives of people on dialysis? (SWIFT) - Pilot study of acceptability and feasibility
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Scientific title
Can Symptom monitoring With Feedback to clinicians improve the lives of people on dialysis? (SWIFT) - Pilot study of acceptability and feasibility
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Secondary ID [1]
296589
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Nil known
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Universal Trial Number (UTN)
U1111-1223-8909
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Trial acronym
SWIFT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease
310399
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Quality of Life
310400
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Condition category
Condition code
Renal and Urogenital
309116
309116
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0
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Kidney disease
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Public Health
309306
309306
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Both the EQ-5D-5L (5 questions and Visual Analogue Scale) and IPOS-Renal measures (11 Questions) and will be collected by patients using a tablet when they come for their in-centre dialysis sessions, with the EQ-5D measure collected first. The data is stored temporarily on the tablets and then transferred weekly to specifically designed database tables in the ANZDATA registry. The integration of data into the ANZDATA registry allows for easy feedback to unit nurses and nephrologists and also allows for PROMs data to be integrated and analysed as part of the larger ANZDATA dataset. Symptom scores are fed back to the caring nephrologist and nurse unit manager via a secure email system approximately one to two weeks after measurement. Alarming symptoms (scores of 3 or 4) are highlighted in the body of the email with the full list of symptom scores in an attachment; along with evidence based guidelines for symptom management. This could prompt assessment of the patient, and triage as to whether further action is required e.g discussion with multi-disciplinary team or referral.
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Intervention code [1]
312911
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Diagnosis / Prognosis
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Comparator / control treatment
The control treatment is the collection of EQ-5D-5L (in centre via tablets) at baseline and 6-months.
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Control group
Active
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Outcomes
Primary outcome [1]
308113
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Overall response rate of EQ-5D-5L & IPOS renal surveys calculated as the number of complete surveys over the total number of surveys given to patients
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Assessment method [1]
308113
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Timepoint [1]
308113
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EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months
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Primary outcome [2]
308115
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Overall completeness of surveys, calculated as the proportion of core questions completed per survey (some questions from the IPOS Renal are optional and these will not be included in completeness calculations)
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Assessment method [2]
308115
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Timepoint [2]
308115
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EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months
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Primary outcome [3]
308116
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Thematic analysis of transcripts from interviews with nurse unit managers and nephrologists and focus groups with patients to elicit the facilitators and barriers to implementation of electronic patient reported outcome measures (ePROMs)
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Assessment method [3]
308116
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Timepoint [3]
308116
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Focus groups and interviews with patients and clinical staff after completion of the 6 month ePROMs data collection
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Secondary outcome [1]
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Time taken to complete ePROMs data collection, measured using metrics built into Qualtrics
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Assessment method [1]
353983
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Timepoint [1]
353983
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EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months
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Secondary outcome [2]
354064
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Email activity metrics (measured via Mail Chimp) to examine the proportion of feedback emails that were opened
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Assessment method [2]
354064
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Timepoint [2]
354064
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Baseline, 3 and 6 months for intervention arm (no measurement for control arm as no symptom score emails are sent)
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Secondary outcome [3]
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Representativeness of patient population, by examining the cohort who participated in the trial compared to the eligible cohort (identified using ANZDATA)
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Assessment method [3]
354641
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Timepoint [3]
354641
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Total number of participants at each site who were enrolled in the trial at the time of site commencement, compared to those eligible for participation at the time of site enrolment.
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Eligibility
Key inclusion criteria
Adults aged 18 years and older with ESKD receiving in-centre haemodialysis or haemodiafiltration.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Non - English speaking participants who would require additional translation services that are not existing as part of usual care
Patients likely to be transplanted or transitioned to PD or Home HD within the next 3 months
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of the site to a treatment arm is centralised (not performed at the individual site)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation
Stratification factors include: Geographical state; prior use of IPOS-Renal; and measure of self-assessed dialysis staff computer literacy
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics only, no power calculations required to meet study objectives.
Quantitative data analysis-
Descriptive statistics for response rate, completeness, representativeness, email activity metrics and time taken to complete the surveys
Qualitative Data analysis-
Thematic analysis of interviews and focus groups
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2019
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Actual
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Date of last participant enrolment
Anticipated
1/06/2019
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Actual
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Date of last data collection
Anticipated
31/12/2019
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Actual
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Sample size
Target
183
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
12411
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
12412
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The Queen Elizabeth Hospital - Woodville
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Recruitment hospital [3]
12413
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Gawler Health Service - Gawler East
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Recruitment hospital [4]
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NephroCare Payneham Dialysis Clinic - Payneham
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Recruitment hospital [5]
12479
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
24684
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5000 - Adelaide
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Recruitment postcode(s) [2]
24685
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5011 - Woodville
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Recruitment postcode(s) [3]
24686
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5118 - Gawler East
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Recruitment postcode(s) [4]
24687
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5070 - Payneham
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Recruitment postcode(s) [5]
24780
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
301167
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Charities/Societies/Foundations
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Name [1]
301167
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Kidney Health Australia
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Address [1]
301167
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Kidney Health Australia Offices
125 Cecil Street, South Melbourne VIC 3205
Post: GPO Box 9993, Melbourne VIC 3001 Australia
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Country [1]
301167
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Australia
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Primary sponsor type
University
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Name
NHMRC Clinical Trials Centre - University of Sydney
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Address
NHMRC Clinical Trials Centre - University of Sydney
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
300789
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Other Collaborative groups
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Name [1]
300789
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South Australian Health and Medical Research Institute
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Address [1]
300789
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SAHMRI Building
North Terrace
Adelaide 5000
South Australia
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Country [1]
300789
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301911
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Central Adelaide Local Health Network Human Research Ethics Committee
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Ethics committee address [1]
301911
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Central Adelaide Local Health Network Human (CAHLN) Research Ethics Committee
L3, Roma Mitchell House
North Terrace
Adelaide SA 5000
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Ethics committee country [1]
301911
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Australia
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Date submitted for ethics approval [1]
301911
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16/07/2018
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Approval date [1]
301911
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04/09/2018
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Ethics approval number [1]
301911
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Summary
Brief summary
Treatment of end-stage kidney disease for more than 2 million people worldwide, including 13,000 Australians on dialysis is extremely costly ($1.1billion per year) yet results in poor survival (45% at 5-years), lower than all cancers combined. Health-related quality of life for people managed on haemodialysis is low, around 60% of full health. Both women and men on haemodialysis frequently experience symptoms of severe or overwhelming pain, fatigue, nausea, cramping, itching, trouble sleeping and depression which contributes to a poor quality of life.
The problem is standard dialysis care does not focus on patient-centered outcomes like health-related quality of life or symptoms; instead the focus is on the management of biomarkers (e.g. urea, potassium, phosphate). This has resulted in missed opportunities to intervene and improve symptom management and overall quality of life. New data from other areas suggest symptom monitoring may not only improve quality of life, but also improve overall survival.
The Symptom monitoring WIth Feedback Trial (SWIFT) is a novel Australia & New Zealand Dialysis and Transplant Association (ANZDATA) registry-based cluster randomised trial to improve the lives of people on kidney dialysis. We will test the hypothesis that: symptom monitoring using the IPOS-Renal with feedback to clinicians, improves health-related quality of life (measured by the EQ-5D-5L) and cause specific mortality among participants receiving haemodialysis.
The SWIFT pilot study will assess the feasibility of electronic capture of patient reported outcomes using tablet computers, and feeding back this information to clinicians, for discussion in clinical consultations.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
88530
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A/Prof Rachael Morton
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Address
88530
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NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
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Country
88530
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Australia
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Phone
88530
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+61 2 9562 5013
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Fax
88530
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Email
88530
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[email protected]
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Contact person for public queries
Name
88531
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Mrs Kathryn Dansie
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Address
88531
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ANZDATA Registry
SAHMRI Building
North Terrace
Adelaide SA 5001
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Country
88531
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Australia
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Phone
88531
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+61 08 8128 4766
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Fax
88531
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Email
88531
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[email protected]
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Contact person for scientific queries
Name
88532
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A/Prof Rachael Morton
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Address
88532
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NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
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Country
88532
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Australia
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Phone
88532
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+61 2 9562 5013
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Fax
88532
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Email
88532
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Making individual participant data (IPD) publically available is not necessary to achieve the outcomes of this trial and hence will not occur.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
267
Ethical approval
376368-(Uploaded-15-11-2018-11-34-10)-Study-related document.pdf
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
The role of kidney registries in expediting large-scale collection of patient-reported outcome measures for people with chronic kidney disease.
2021
https://dx.doi.org/10.1093/ckj/sfab061
Embase
Feasibility of Symptom monitoring WIth Feedback Trial (SWIFT) for adults on hemodialysis: a registry-based cluster randomized pilot trial.
2023
https://dx.doi.org/10.1186/s12882-023-03399-5
Embase
Feasibility and acceptability of e-PROMs data capture and feedback among patients receiving haemodialysis in the Symptom monitoring with Feedback Trial (SWIFT) pilot: Protocol for a qualitative study in Australia.
2020
https://dx.doi.org/10.1136/bmjopen-2020-039014
N.B. These documents automatically identified may not have been verified by the study sponsor.
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