ANZCTR - Registration

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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]

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

Quality of Life

Condition category

Condition code

Renal and Urogenital

Kidney disease

Public Health

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]

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]

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]

EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months

Primary outcome [2]

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]

EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months

Primary outcome [3]

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]

Focus groups and interviews with patients and clinical staff after completion of the 6 month ePROMs data collection

Secondary outcome [1]

Time taken to complete ePROMs data collection, measured using metrics built into Qualtrics

Timepoint [1]

EQ-5D-5L surveys at baseline and 6 months and IPOS-Renal surveys at baseline, 3 and 6 months

Secondary outcome [2]

Email activity metrics (measured via Mail Chimp) to examine the proportion of feedback emails that were opened

Timepoint [2]

Baseline, 3 and 6 months for intervention arm (no measurement for control arm as no symptom score emails are sent)

Secondary outcome [3]

Representativeness of patient population, by examining the cohort who participated in the trial compared to the eligible cohort (identified using ANZDATA)

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2019

Actual

Date of last participant enrolment

Anticipated

1/06/2019

Actual

Date of last data collection

Anticipated

31/12/2019

Actual

Sample size

Target

183

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD,SA

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [3]

Gawler Health Service - Gawler East

Recruitment hospital [4]

NephroCare Payneham Dialysis Clinic - Payneham

Recruitment hospital [5]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5011 - Woodville

Recruitment postcode(s) [3]

5118 - Gawler East

Recruitment postcode(s) [4]

5070 - Payneham

Recruitment postcode(s) [5]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Kidney Health Australia

Address [1]

Kidney Health Australia Offices
125 Cecil Street, South Melbourne VIC 3205
Post: GPO Box 9993, Melbourne VIC 3001 Australia

Country [1]

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]

Other Collaborative groups

Name [1]

South Australian Health and Medical Research Institute

Address [1]

SAHMRI Building
North Terrace
Adelaide 5000
South Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

Central Adelaide Local Health Network Human (CAHLN) Research Ethics Committee
L3, Roma Mitchell House 
North Terrace
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/07/2018

Approval date [1]

04/09/2018

Ethics approval number [1]

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

A/Prof Rachael Morton

Address

NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9562 5013

Fax

rachael.morton@ctc.usyd.edu.au

Contact person for public queries

Name

Kathryn Dansie

Address

ANZDATA Registry
SAHMRI Building
North Terrace
Adelaide SA 5001

Country

Australia

Phone

+61 08 8128 4766

Fax

kathryn@anzdata.org.au

Contact person for scientific queries

Name

Rachael Morton

Address

NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building
92-94 Parramatta Rd
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9562 5013

Fax

rachael.morton@ctc.usyd.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

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	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
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

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Did you know?

Documents added manually

Documents added automatically