Symptom Management in Patients on Dialysis

NCT05515991 | Active Not Recruiting

• 2 other identifiers: 22-5199UHNKHERGePROMSUPPORTDIALYSIS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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 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).

Conditions

End-stage Kidney Disease

Keywords

end-stage renal disease; hemodialysis; dialysis; chronic kidney disease; kidney failure

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline

• Proportion of Eligible Patients who decline consent

  Feasibility of toolkit will be confirmed if decline rate is \<50% for eligible patients.

  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.

  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%.

  Baseline to follow-up (6 months)

Secondary Outcomes (2)

• Patient Acceptability

  Follow-up (every 4 weeks, up to 6 months)

• Clinical Team Acceptability

  Follow-up (every 4 weeks, up to 6 months)

Other Outcomes (4)

• Incidence Rate of Healthcare Use

  Baseline to Follow-up (6 months)

• Physical Health Component Score

  Baseline to Follow-up (6 months)

• Mental Health Component Score

  Baseline to Follow-up (6 months)

Study Arms (2)

SUPPORT-DIALYSIS with Access to Output Report and Information Hub

EXPERIMENTAL

Feasibility of SUPPORT-Dialysis at Toronto General Hospital

Other: SUPPORT-DIALYSIS with Access to Output Report and Information Hub

SUPPORT-DIALYSIS Only

EXPERIMENTAL

Usual Treatment at Humber River Hospital

Other: SUPPORT-DIALYSIS Only

Interventions

SUPPORT-DIALYSIS with Access to Output Report and Information Hub OTHER

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 with Access to Output Report and Information Hub

SUPPORT-DIALYSIS Only OTHER

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.

SUPPORT-DIALYSIS Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing maintenance hemodialysis for more than 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Humber River Hospital: collaborator

Study Sites (2)

Etobicoke General Hospital

Brampton, Ontario, M9V 0A9, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (13)

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  PMID: 15549424 BACKGROUND

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  BACKGROUND

• 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.

  PMID: 22543292 BACKGROUND

• Dudgeon 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.

  PMID: 21308858 BACKGROUND

• Barbera 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.

  PMID: 25711657 BACKGROUND

• Gill 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.

  PMID: 38296283 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Istvan Mucsi

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 25, 2022
• Study Start: April 19, 2023
• Primary Completion: January 9, 2024
• Study Completion: December 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound purpose to achieve aims in the approved proposal or for individual participant data meta-analysis. Proposals should be directed to istvan.mucsi@uhn.ca. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.

Locations

CA (2)