Please note that the ANZCTR website will be unavailable from 12am until 6am (AEST) on Sunday 22nd September 2019. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Can Symptom monitoring With Feedback to clinicians improve the lives of people on dialysis? (SWIFT) - Pilot study of acceptability and feasibility
Secondary ID [1] 296589 0
Nil known
Universal Trial Number (UTN)
U1111-1223-8909
Trial acronym
SWIFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 310399 0
Quality of Life 310400 0
Condition category
Condition code
Renal and Urogenital 309116 309116 0 0
Kidney disease
Public Health 309306 309306 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312911 0
Diagnosis / Prognosis
Comparator / control treatment
The control treatment is the collection of EQ-5D-5L (in centre via tablets) at baseline and 6-months.
Control group
Active

Outcomes
Primary outcome [1] 308113 0
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
Timepoint [1] 308113 0
EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months
Primary outcome [2] 308115 0
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)
Timepoint [2] 308115 0
EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months
Primary outcome [3] 308116 0
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)
Timepoint [3] 308116 0
Focus groups and interviews with patients and clinical staff after completion of the 6 month ePROMs data collection
Secondary outcome [1] 353983 0
Time taken to complete ePROMs data collection, measured using metrics built into Qualtrics
Timepoint [1] 353983 0
EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months
Secondary outcome [2] 354064 0
Email activity metrics (measured via Mail Chimp) to examine the proportion of feedback emails that were opened
Timepoint [2] 354064 0
Baseline, 3 and 6 months for intervention arm (no measurement for control arm as no symptom score emails are sent)
Secondary outcome [3] 354641 0
Representativeness of patient population, by examining the cohort who participated in the trial compared to the eligible cohort (identified using ANZDATA)
Timepoint [3] 354641 0
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.

Eligibility
Key inclusion criteria
Adults aged 18 years and older with ESKD receiving in-centre haemodialysis or haemodiafiltration.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
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)
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 12411 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 12412 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 12413 0
Gawler Health Service - Gawler East
Recruitment hospital [4] 12414 0
NephroCare Payneham Dialysis Clinic - Payneham
Recruitment hospital [5] 12479 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 24684 0
5000 - Adelaide
Recruitment postcode(s) [2] 24685 0
5011 - Woodville
Recruitment postcode(s) [3] 24686 0
5118 - Gawler East
Recruitment postcode(s) [4] 24687 0
5070 - Payneham
Recruitment postcode(s) [5] 24780 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301167 0
Charities/Societies/Foundations
Name [1] 301167 0
Kidney Health Australia
Address [1] 301167 0
Kidney Health Australia Offices
125 Cecil Street, South Melbourne VIC 3205
Post: GPO Box 9993, Melbourne VIC 3001 Australia
Country [1] 301167 0
Australia
Primary sponsor type
University
Name
NHMRC Clinical Trials Centre - University of Sydney
Address
NHMRC Clinical Trials Centre - University of Sydney
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 300789 0
Other Collaborative groups
Name [1] 300789 0
South Australian Health and Medical Research Institute
Address [1] 300789 0
SAHMRI Building
North Terrace
Adelaide 5000
South Australia
Country [1] 300789 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301911 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 301911 0
Central Adelaide Local Health Network Human (CAHLN) Research Ethics Committee
L3, Roma Mitchell House
North Terrace
Adelaide SA 5000
Ethics committee country [1] 301911 0
Australia
Date submitted for ethics approval [1] 301911 0
16/07/2018
Approval date [1] 301911 0
04/09/2018
Ethics approval number [1] 301911 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88530 0
A/Prof Rachael Morton
Address 88530 0
NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
Country 88530 0
Australia
Phone 88530 0
+61 2 9562 5013
Fax 88530 0
Email 88530 0
rachael.morton@ctc.usyd.edu.au
Contact person for public queries
Name 88531 0
Mrs Kathryn Dansie
Address 88531 0
ANZDATA Registry
SAHMRI Building
North Terrace
Adelaide SA 5001
Country 88531 0
Australia
Phone 88531 0
+61 08 8128 4766
Fax 88531 0
Email 88531 0
kathryn@anzdata.org.au
Contact person for scientific queries
Name 88532 0
A/Prof Rachael Morton
Address 88532 0
NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
Country 88532 0
Australia
Phone 88532 0
+61 2 9562 5013
Fax 88532 0
Email 88532 0
rachael.morton@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 267 0
Ethical approval
Citation [1] 267 0
Link [1] 267 0
Email [1] 267 0
Other [1] 267 0
Summary results
No Results