End-stage Kidney DiseaseNCT05515991
Symptom Management in Patients on Dialysis
A study testing SUPPORT-DIALYSIS with Access to Output Report and Information Hub and SUPPORT-DIALYSIS Only in people with End-stage Kidney Disease, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
This is a parallel arm, pilot study used to examine the feasibility of electronic patient reported outcome measures (ePROMs) for symptom assessment and monitoring as well as a linked self-management support and decision support information hub (https://symptomcare.org) to facilitate symptom management for patients on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Kidney Disease
- What is being tested?
- SUPPORT-DIALYSIS with Access to Output Report and Information Hub and SUPPORT-DIALYSIS Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Apr 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing maintenance hemodialysis for more than 3 months
Who cannot join
- Patients with severe acute illness or condition that hampers questionnaire completion assessed by clinical team.
- Dementia indicated in the medical record, indicated by the managing healthcare team.
- Unable to understand English - as assessed by clinical team.
- Life expectancy < 6 months as assessed by main responsible nephrologist.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Etobicoke General Hospital
Brampton, Ontario, M9V 0A9
Toronto General Hospital
Toronto, Ontario, M5G2C4
About this study
Official title: Assessing the Feasibility of Self-reported MeasUrement of Physical and PsychosOcial Symptoms and Response Tool in Patients on Dialysis- Pilot Study
This is a parallel arm, pilot study used to examine the feasibility of electronic patient reported outcome measures (ePROMs) for symptom assessment and monitoring as well as a linked self-management support and decision support information hub (https://symptomcare.org) to facilitate symptom management for patients on maintenance hemodialysis.
Two dialysis centers will be included in the study, with one center receiving SUPPORT-Dialysis (intervention arm) and the other receiving standard care (control arm).
Read the detailed description
In Canada, 20,000-25,000 patients with end-stage kidney disease (ESKD) experience a range of symptoms such as chronic pain, itchiness, fatigue, anxiety, depression and sleep disturbances [1-5]. These may impact quality of life, increase mortality, decrease treatment adherence, and increased hospitalizations [6-8]. These symptoms are under-managed and under-recognized among these patients, but screening and managing symptoms using patient reported outcomes measures (PROMs) may be a useful and inexpensive solution. PROMS have previously been used successfully in cancer care [8-9], and have potential for clinical care of patients with kidney failure as well.
Electronic collection of PROMs (ePROMs) facilitates PROMs use by allowing linkage to electronic patient records [10-11] and immediate scoring and presentation of results to patients and clinicians [12-14]. ePROMs allow the use of computer adaptive testing (CAT) to personalize questions, increase the precision of measurements and reduce survey burden [15-17]. The investigators also developed a self-management support and decision support resource hub(https://symptomcare.org) to help dialysis patients and their clinical team in identifying and managing relevant physical and psychological symptoms that require further assessment and potential intervention.
Patients will complete Patient Reported Outcome Measurement Information System (PROMIS) CAT surveys on an electronic data capture system (SUPPORT-Dialysis) every four weeks during their dialysis treatment for six months. In the intervention, patients with moderate/severe symptoms will be flagged for the clinical team. Moderate/severe symptoms will be determined based on whether the participants score above a pre-defined cut-off in the surveys. The participant, primary nurse, and nephrologist will also receive an output report and be given access to https://symptomcare.org for suggested symptom management actions.
To establish the feasibility and acceptability of the intervention, the investigators will assess
- Recruitment Rate
- Retention and Completion rate
- Acceptability
- Patient satisfaction
- Staff satisfaction
Based on the objectives of this study, the investigators hypothesize the following:
- Recruitment goals will be met; >50% of approached patients will consent; completion rate will be > 80% of participants at least 50% of the time, and dropout rate will be < 30%.
- >80% of patients find the toolkit acceptable; <20% of staff find the process intrusive to workflow.
- Conditions
- End-stage Kidney Disease
- Being tested
- SUPPORT-DIALYSIS with Access to Output Report and Information Hub, SUPPORT-DIALYSIS Only
- Keywords
- end-stage renal disease, hemodialysis, dialysis, chronic kidney disease, kidney failure
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPPORT-DIALYSIS with Access to Output Report and Information HubOther
SUPPORT-Dialysis is a symptom assessment response toolkit, consisting of a screening and response component. Participants will be screened for symptoms and distress using an electronic assessment(ePROMs). Output reports based on ePROMs scores will be provided to patients as well as the clinical care team.
Participants at Toronto General Hospital will complete the screening every 4 weeks for 6 months, and each time the output report will be provided to both patients and the clinical team.The second, response component of the intervention is the information support and self-management hub (https://symptomcare.org). All participants and the clinical team will be given access to this website, which provides information about self-management for patients as well as management advice for healthcare professionals.
SUPPORT-DIALYSIS OnlyOther
SUPPORT-Dialysis screening will also be implemented at Humber River Hospital, but participants and clinical team will not be receiving the output screening report or be given access to the information hub with symptom management resources.
| Study group | Role | What they receive |
|---|---|---|
| SUPPORT-DIALYSIS with Access to Output Report and Information Hub | Experimental | Feasibility of SUPPORT-Dialysis at Toronto General Hospital Receives: Other: SUPPORT-DIALYSIS with Access to Output Report and Information Hub |
| SUPPORT-DIALYSIS Only | Experimental | Usual Treatment at Humber River Hospital Receives: Other: SUPPORT-DIALYSIS Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Target
Feasibility of toolkit will be confirmed if recruitment target of 30 participants at each site are obtained in a 3-month period of the pilot.
Measured: Baseline
Proportion of Eligible Patients who decline consent
Feasibility of toolkit will be confirmed if decline rate is <50% for eligible patients.
Measured: Baseline
Proportion of Participants who miss or refuse ePROMs follow-ups
Feasibility of toolkit will be confirmed if <30% of participants complete <50% of all follow-up visits.
Measured: Baseline to follow-up (6 months)
Proportion of Enrolled Patients who Drop-Out From the Study
Feasibility of toolkit will be confirmed if the dropout rate is < 30%.
Measured: Baseline to follow-up (6 months)
Secondary outcomes (2)
Patient Acceptability
Proportion of patients who find the tool 1) acceptable, 2) not burdensome and 3) important, based on responses to the "Patient Satisfaction Survey" they will complete.
Measured: Follow-up (every 4 weeks, up to 6 months)
Clinical Team Acceptability
Proportion of staff who do not find the use of the tool intrusive to the workflow, based on responses to the "Staff Satisfaction Survey" they will complete.
Measured: Follow-up (every 4 weeks, up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start19 Apr 2023
- Primary completion9 Jan 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for End-stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Humber River Hospital
- Responsible party
- Sponsor
- Investigators
- Istvan Mucsi, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515991
- Sponsor's protocol ID
- 22-5199
- Other IDs
- UHNKHERGePROMSUPPORTDIALYSIS
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
Publications
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Spitzer RL, Williams JB, Kroenke K, Hornyak R, McMurray J. Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics-Gynecology Study. Am J Obstet Gynecol. 2000 Sep;183(3):759-69. doi: 10.1067/mob.2000.106580.
PubMed 10992206Davison SN, Jhangri GS, Johnson JA. Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients. Nephrol Dial Transplant. 2006 Nov;21(11):3189-95. doi: 10.1093/ndt/gfl380. Epub 2006 Sep 6.
PubMed 16957010Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
PubMed 12831398Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51.
PubMed 20482853Van Belle S, Paridaens R, Evers G, Kerger J, Bron D, Foubert J, Ponnet G, Vander Steichel D, Heremans C, Rosillon D. Comparison of proposed diagnostic criteria with FACT-F and VAS for cancer-related fatigue: proposal for use as a screening tool. Support Care Cancer. 2005 Apr;13(4):246-54. doi: 10.1007/s00520-004-0734-y. Epub 2004 Nov 12.
PubMed 15549424Tam E, Chen J, Zhang Q, et al. Routine physical function assessment through a Branching Logic Electronic Symptom Survey (BLESS) vs. the 32-combined item HAQ-DI + WHODAS (HW) survey: A quality improvement controlled trial. Journal of Clinical Oncology 2017;35:136.
Howell D, Liu G. Can routine collection of patient reported outcome data actually improve person-centered health? Healthc Pap. 2011;11(4):42-7; discussion 55-8. doi: 10.12927/hcpap.2012.22703.
PubMed 22543292Dudgeon D, King S, Howell D, Green E, Gilbert J, Hughes E, Lalonde B, Angus H, Sawka C. Cancer Care Ontario's experience with implementation of routine physical and psychological symptom distress screening. Psychooncology. 2012 Apr;21(4):357-64. doi: 10.1002/pon.1918. Epub 2011 Feb 8.
PubMed 21308858Barbera L, Sutradhar R, Howell D, Sussman J, Seow H, Dudgeon D, Atzema C, Earle C, Husain A, Liu Y, Krzyzanowska MK. Does routine symptom screening with ESAS decrease ED visits in breast cancer patients undergoing adjuvant chemotherapy? Support Care Cancer. 2015 Oct;23(10):3025-32. doi: 10.1007/s00520-015-2671-3. Epub 2015 Feb 26.
PubMed 25711657Gill JK, Pucci M, Samudio A, Ahmed T, Siddiqui R, Edwards N, Marticorena RM, Donnelly S, Lok C, Wentlandt K, Wolofsky K, Mucsi I. Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis - a parallel arm, non-randomised feasibility pilot study protocol. BMJ Open. 2024 Jan 30;14(1):e080712. doi: 10.1136/bmjopen-2023-080712.
PubMed 38296283
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Self-reported MeasUrement of Physical and PsychosOcial Symptoms and Response Tool in Patients on Dialysis- Pilot Study
- ClinicalTrials.gov ID
- NCT05515991
- Acronym / sponsor ID
- 22-5199
- Conditions
- End-stage Kidney Disease
- Keywords
- end-stage renal disease, hemodialysis, dialysis, chronic kidney disease, kidney failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Humber River Hospital
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a parallel arm, pilot study used to examine the feasibility of electronic patient reported outcome measures (ePROMs) for symptom assessment and monitoring as well as a linked self-management support and decision support information hub (https://symptomcare.org) to facilitate symptom management for patients on maintenance hemodialysis.
Two dialysis centers will be included in the study, with one center receiving SUPPORT-Dialysis (intervention arm) and the other receiving standard care (control arm).
Detailed description
In Canada, 20,000-25,000 patients with end-stage kidney disease (ESKD) experience a range of symptoms such as chronic pain, itchiness, fatigue, anxiety, depression and sleep disturbances [1-5]. These may impact quality of life, increase mortality, decrease treatment adherence, and increased hospitalizations [6-8]. These symptoms are under-managed and under-recognized among these patients, but screening and managing symptoms using patient reported outcomes measures (PROMs) may be a useful and inexpensive solution. PROMS have previously been used successfully in cancer care [8-9], and have potential for clinical care of patients with kidney failure as well.
Electronic collection of PROMs (ePROMs) facilitates PROMs use by allowing linkage to electronic patient records [10-11] and immediate scoring and presentation of results to patients and clinicians [12-14]. ePROMs allow the use of computer adaptive testing (CAT) to personalize questions, increase the precision of measurements and reduce survey burden [15-17]. The investigators also developed a self-management support and decision support resource hub(https://symptomcare.org) to help dialysis patients and their clinical team in identifying and managing relevant physical and psychological symptoms that require further assessment and potential intervention.
Patients will complete Patient Reported Outcome Measurement Information System (PROMIS) CAT surveys on an electronic data capture system (SUPPORT-Dialysis) every four weeks during their dialysis treatment for six months. In the intervention, patients with moderate/severe symptoms will be flagged for the clinical team. Moderate/severe symptoms will be determined based on whether the participants score above a pre-defined cut-off in the surveys. The participant, primary nurse, and nephrologist will also receive an output report and be given access to https://symptomcare.org for suggested symptom management actions.
To establish the feasibility and acceptability of the intervention, the investigators will assess
- Recruitment Rate
- Retention and Completion rate
- Acceptability
- Patient satisfaction
- Staff satisfaction
Based on the objectives of this study, the investigators hypothesize the following:
- Recruitment goals will be met; >50% of approached patients will consent; completion rate will be > 80% of participants at least 50% of the time, and dropout rate will be < 30%.
- >80% of patients find the toolkit acceptable; <20% of staff find the process intrusive to workflow.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUPPORT-DIALYSIS with Access to Output Report and Information Hub | Experimental | Other: SUPPORT-DIALYSIS with Access to Output Report and Information HubFeasibility of SUPPORT-Dialysis at Toronto General Hospital |
| SUPPORT-DIALYSIS Only | Experimental | Other: SUPPORT-DIALYSIS OnlyUsual Treatment at Humber River Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing maintenance hemodialysis for more than 3 months
Key exclusion criteria (5 listed)
- Patients with severe acute illness or condition that hampers questionnaire completion assessed by clinical team.
- Dementia indicated in the medical record, indicated by the managing healthcare team.
- Unable to understand English - as assessed by clinical team.
- Life expectancy < 6 months as assessed by main responsible nephrologist.
- Unwilling or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPPORT-DIALYSIS with Access to Output Report and Information HubSUPPORT-Dialysis is a symptom assessment response toolkit, consisting of a screening and response component. Participants will be screened for symptoms and distress using an electronic assessment(ePROMs). Output reports based on ePROMs scores will be provided to patients as well as the clinical care team. Participants at Toronto General Hospital will complete the screening every 4 weeks for 6 months, and each time the output report will be provided to both patients and the clinical team.The second, response component of the intervention is the information support and self-management hub (https://symptomcare.org). All participants and the clinical team will be given access to this website, which provides information about self-management for patients as well as management advice for healthcare professionals. | Other | SUPPORT-DIALYSIS with Access to Output Report and Information Hub |
| SUPPORT-DIALYSIS OnlySUPPORT-Dialysis screening will also be implemented at Humber River Hospital, but participants and clinical team will not be receiving the output screening report or be given access to the information hub with symptom management resources. | Other | SUPPORT-DIALYSIS Only |
Primary outcome
Recruitment Target
Time frame: Baseline
Feasibility of toolkit will be confirmed if recruitment target of 30 participants at each site are obtained in a 3-month period of the pilot.
Proportion of Eligible Patients who decline consent
Time frame: Baseline
Feasibility of toolkit will be confirmed if decline rate is <50% for eligible patients.
Proportion of Participants who miss or refuse ePROMs follow-ups
Time frame: Baseline to follow-up (6 months)
Feasibility of toolkit will be confirmed if <30% of participants complete <50% of all follow-up visits.
Proportion of Enrolled Patients who Drop-Out From the Study
Time frame: Baseline to follow-up (6 months)
Feasibility of toolkit will be confirmed if the dropout rate is < 30%.
2 secondary outcomes
Patient Acceptability
Time frame: Follow-up (every 4 weeks, up to 6 months)
Clinical Team Acceptability
Time frame: Follow-up (every 4 weeks, up to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 10992206Spitzer RL, Williams JB, Kroenke K, Hornyak R, McMurray J. Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics-Gynecology Study. Am J Obstet Gynecol. 2000 Sep;183(3):759-69. doi: 10.1067/mob.2000.106580.
- Background: PubMed 16957010Davison SN, Jhangri GS, Johnson JA. Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients. Nephrol Dial Transplant. 2006 Nov;21(11):3189-95. doi: 10.1093/ndt/gfl380. Epub 2006 Sep 6.
- Background: PubMed 12831398Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
- Background: PubMed 20482853Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51.
- Background: PubMed 15549424Van Belle S, Paridaens R, Evers G, Kerger J, Bron D, Foubert J, Ponnet G, Vander Steichel D, Heremans C, Rosillon D. Comparison of proposed diagnostic criteria with FACT-F and VAS for cancer-related fatigue: proposal for use as a screening tool. Support Care Cancer. 2005 Apr;13(4):246-54. doi: 10.1007/s00520-004-0734-y. Epub 2004 Nov 12.
- BackgroundTam E, Chen J, Zhang Q, et al. Routine physical function assessment through a Branching Logic Electronic Symptom Survey (BLESS) vs. the 32-combined item HAQ-DI + WHODAS (HW) survey: A quality improvement controlled trial. Journal of Clinical Oncology 2017;35:136.
- Background: PubMed 22543292Howell D, Liu G. Can routine collection of patient reported outcome data actually improve person-centered health? Healthc Pap. 2011;11(4):42-7; discussion 55-8. doi: 10.12927/hcpap.2012.22703.
- Background: PubMed 21308858Dudgeon D, King S, Howell D, Green E, Gilbert J, Hughes E, Lalonde B, Angus H, Sawka C. Cancer Care Ontario's experience with implementation of routine physical and psychological symptom distress screening. Psychooncology. 2012 Apr;21(4):357-64. doi: 10.1002/pon.1918. Epub 2011 Feb 8.
- Background: PubMed 25711657Barbera L, Sutradhar R, Howell D, Sussman J, Seow H, Dudgeon D, Atzema C, Earle C, Husain A, Liu Y, Krzyzanowska MK. Does routine symptom screening with ESAS decrease ED visits in breast cancer patients undergoing adjuvant chemotherapy? Support Care Cancer. 2015 Oct;23(10):3025-32. doi: 10.1007/s00520-015-2671-3. Epub 2015 Feb 26.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Istvan Mucsi principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUPPORT-DIALYSIS with Access to Output Report and Information Hub and SUPPORT-DIALYSIS Only in people with End-stage Kidney Disease, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Target (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515991, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.