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Trial registered on ANZCTR


Registration number
ACTRN12620001061921
Ethics application status
Approved
Date submitted
16/07/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Symptom monitoring WIth Feedback Trial (SWIFT).
Scientific title
A Registry-Based Cluster Randomised Controlled Trial to determine the clinical effectiveness and cost-effectiveness of symptom monitoring with feedback to clinicians compared with standard care in improving quality of life outcomes at 12 months for adults on haemodialysis.
Secondary ID [1] 301792 0
None.
Universal Trial Number (UTN)
Trial acronym
SWIFT
Linked study record
The success of SWIFT Pilot study (ACTRN12618001976279) led to the current SWIFT study.

Health condition
Health condition(s) or problem(s) studied:
Health-related quality of life 318268 0
Condition category
Condition code
Renal and Urogenital 316280 316280 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial data collection period is 12 months for a site. All participants at a site will complete their questionnaires a 2-week data collection period at timepoints determined by which arm the site is randomised to. If a site is randomised to the control arm, participants will complete the EQ-5D-5L and Song-HD Fatique questionnaires at baseline, 6 months and 12 months. If a site is randomised to the intervention arm, participants will complete the same questionnaires as the control arm plus the IPOS Renal at baseline, 3 months, 6 months, 9 months and 12 months. For participants who complete the IPOS Renal (intervention sites), the questionnaire results will be emailed to the dialysis nurse unit manager and the participant's treating nephrologist after the conclusion of the 2-week data collection period has concluded for each timepoint. Any scores of 3 or 4 will be highlighted in the email with an asterisk and accompanied by a link to evidence-based guidelines for symptom management.

Data collection is performed by the participant completing the questionnaires on a tablet. This trial collects patient report outcomes, so nurses may assist with use of the tablet but the responses to surveys are provided by the participant. In some cases, a nurse may assist with using the tablet on behalf of the participant but the nurse must enter the responses that the participant reports.

Information from the ANZDATA Registry allows participants at each site to be linked to their treating nephrologist so their survey results can be relayed to their clinician. The survey data is entered on to the tablet and then automatically transferred to the study database.
Intervention code [1] 318095 0
Diagnosis / Prognosis
Comparator / control treatment
The control treatment is the collection of EQ-5D-5L and SONG-HD Fatigue at baseline, 6 months and 12 months.

The control arm do not receive feedback of the IPOS Renal scores to clinicians, as only the intervention arm complete the IPOS Renal questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 324460 0
Change in health-related quality of life, as measured by using a composite of questionnaires. Both the control and intervention groups complete the EQ-5D-5L and Song-HD Fatigue questionnaires, and the intervention group complete the additional IPOS Renal questionnaire.
Timepoint [1] 324460 0
12 months.
Secondary outcome [1] 384720 0
Dialysis withdrawal (data provided by the ANZDATA Registry).
Timepoint [1] 384720 0
12 months.
Secondary outcome [2] 387892 0
Overall mortality (data provided by the ANZDATA Registry).
Timepoint [2] 387892 0
12 months.
Secondary outcome [3] 387893 0
Frequency and severity of symptoms: a composite outcome using SONG-HD Fatigue core outcome measure, change in IPOS Renal scores.

Timepoint [3] 387893 0
12 months.
Secondary outcome [4] 387894 0
Haemodialysis duration and frequency and biochemical measures of adequacy (dose) (data provided by the ANZDATA Registry).
Timepoint [4] 387894 0
12 months.
Secondary outcome [5] 387895 0
Symptom-related and general healthcare utilisation (hospitalisations, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme items). Linkage with the consolidated national data asset will be sought if available at the study end.
Timepoint [5] 387895 0
12 months.
Secondary outcome [6] 387896 0
Cost-effectiveness of symptom monitoring with feedback and QOL collection, versus no symptom monitoring or feedback at 12 months will be calculated from the perspective of the health system.
Timepoint [6] 387896 0
12 months.
Secondary outcome [7] 387897 0
Distribution of health benefits by Indigenous status / ethnicity and other factors of social disadvantage e.g. low socio-economic status, rural or remote residence (data provided by the ANZDATA Registry and Services Australia).
Timepoint [7] 387897 0
12 months.

Eligibility
Key inclusion criteria
- Adults aged 18 years and older with kidney failure managed with chronic haemodialysis at an Australian or New Zealand haemodialysis facility registered in ANZDATA
- Willing and able to comply with all study requirements
- Provision of consent (provided by adding name and signing in the box provided)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Paediatric centres enrolling only those under 18 years of age.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306226 0
Government body
Name [1] 306226 0
NHMRC Project Grant
Address [1] 306226 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 306226 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] 306704 0
Other Collaborative groups
Name [1] 306704 0
South Australian Health and Medical Research Institute
Address [1] 306704 0
SAHMRI Building
North Terrace
Adelaide 5000
South Australia
Country [1] 306704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306437 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306437 0
Central Adelaide Local Health Network Human (CAHLN) Research Ethics Committee
L3, Roma Mitchell House
North Terrace
Adelaide SA 5000
Ethics committee country [1] 306437 0
Australia
Date submitted for ethics approval [1] 306437 0
20/07/2020
Approval date [1] 306437 0
21/08/2020
Ethics approval number [1] 306437 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.
Trial website
https://ctc.usyd.edu.au/our-work/research-divisions/health-economics/current-key-projects/swift/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103870 0
Prof Rachael Morton
Address 103870 0
NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
Country 103870 0
Australia
Phone 103870 0
+61 02 9562 5000
Fax 103870 0
Email 103870 0
swift@ctc.usyd.edu.au
Contact person for public queries
Name 103871 0
Ms Lavern Greenham
Address 103871 0
ANZDATA Registry
SAHMRI Building
North Terrace
Adelaide SA 5001
Country 103871 0
Australia
Phone 103871 0
+61 08 8128 4264
Fax 103871 0
Email 103871 0
Lavern@anzdata.org.au
Contact person for scientific queries
Name 103872 0
Prof Rachael Morton
Address 103872 0
NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050
Country 103872 0
Australia
Phone 103872 0
+61 02 9562 5000
Fax 103872 0
Email 103872 0
swift@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
What supporting documents are/will be available?
No other documents available
Summary results
No Results