Symptom monitoring With Feedback trial (SWIFT) dataset
The University of SydneyDataset description
This dataset contains the Patient Reported Outcome Measures (PROMs) of the SWIFT participants, a cohort of 2422 satellite dialysis patients clustered into 143 centres across Australia. The PROMs data are the EQ-5D-5L quality of life survey, IPOS-Renal survey and SONg-HD fatigue survey. In addition to the PROMs data, health data from the ANZDATA Registry including health utilisation for hospitalisations, survival data and dialysis modality are in the data set.Identifiers
Source Study
Trial name (public)
Symptom monitoring WIth Feedback Trial (SWIFT).Trial acronym
SWIFT
Trial ID
ACTRN12620001061921
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,NHMRC Project Grant
Scientific enquiries
Prof Rachael Morton
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 an .... Read more
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)
Key Exclusion Criteria
- Paediatric centres enrolling only those under 18 years of age.
Can healthy volunteers participate?
No
Population
Sample Size 2422
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Health-related quality of life
Condition code Renal and Urogenital
Intervention
Intervention code Diagnosis / Prognosis
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 .... Read more
Comparison
Control group Active
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.
Outcomes
Outcome: 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: 12 months.