None listed
Conditions
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.
Interventions
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
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.
Sponsors
NHMRC Clinical Trials Centre - University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
Exclusion criteria
- Paediatric centres enrolling only those under 18 years of age.
Outcome results
None listed