Trial Review

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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
29/08/2022
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. 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 will be calculated using regression models adjusting
for baseline measures. The EQ-5D-5L is anchored on a 0-1 utility scale, where 0=death
and 1=full and complete health. Negative values for states worse than death are possible. Unit
values will be informed by Australian population estimates.
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 fatigue score.

Frequency and severity of symptoms (intervention arm only): change in IPOS Renal scores.
Timepoint [3] 387893 0
SONG-HD Fatigue score: 6 months and 12 months (both arms),
IPOS-Renal score: 1, 6, 9 and 12 months (intervention arm only).
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
Sex
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
Recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
7/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2422
Accrual to date
413
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 23032 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 23033 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 23034 0
Maitland Hospital - Maitland
Recruitment hospital [4] 23035 0
Muswellbrook Hospital - Muswellbrook
Recruitment hospital [5] 23036 0
Singleton District Hospital - Singleton
Recruitment hospital [6] 23037 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [7] 23038 0
Innisfail Hospital - Innisfail
Recruitment hospital [8] 23039 0
Mackay Base Hospital - Mackay
Recruitment hospital [9] 23040 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 23041 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 23042 0
Caloundra Hospital - Caloundra
Recruitment hospital [12] 23043 0
Gympie Hospital - Gympie
Recruitment hospital [13] 23044 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 38357 0
2139 - Concord
Recruitment postcode(s) [2] 38358 0
2050 - Camperdown
Recruitment postcode(s) [3] 38359 0
5573 - Maitland
Recruitment postcode(s) [4] 38360 0
2333 - Muswellbrook
Recruitment postcode(s) [5] 38361 0
2330 - Singleton
Recruitment postcode(s) [6] 38362 0
2324 - Raymond Terrace
Recruitment postcode(s) [7] 38363 0
2290 - Charlestown
Recruitment postcode(s) [8] 38364 0
4670 - Bundaberg
Recruitment postcode(s) [9] 38365 0
4860 - Innisfail
Recruitment postcode(s) [10] 38366 0
4878 - Smithfield
Recruitment postcode(s) [11] 38367 0
4740 - Mackay
Recruitment postcode(s) [12] 38368 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 38369 0
4575 - Birtinya
Recruitment postcode(s) [14] 38370 0
4551 - Caloundra
Recruitment postcode(s) [15] 38371 0
4570 - Gympie
Recruitment postcode(s) [16] 38372 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 306226 0
Government body
Name [1] 306226 0
NHMRC Project Grant
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
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
Trial website
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
[email protected]
Contact person for public queries
Name 103871 0
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
[email protected]
Contact person for scientific queries
Name 103872 0
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
[email protected]

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 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
EmbaseThe Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis.2022https://dx.doi.org/10.1186/s13063-022-06355-0
N.B. These documents automatically identified may not have been verified by the study sponsor.