NCT02202018

Brief Summary

Patients with severe kidney failure require dialysis or transplantation to survive. For those in whom a transplant is not an option, there are two main dialysis options: hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion of home-based therapies varying between 10 and 40% across centres. Studies show that the low use of home dialysis is due to a variety of factors, though patient and provider awareness and knowledge of home dialysis are major factors. In this cluster randomized trial, the investigators will determine whether a standardized modality education program directed at patients, in combination with a provider-directed intervention, can increase the use of home dialysis in incident dialysis patients in Canada.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

July 11, 2014

Last Update Submit

October 9, 2018

Conditions

Chronic Kidney Disease

Keywords

Knowledge TranslationChronic Kidney DiseaseDialysisHome dialysisCluster randomized trial

Outcome Measures

Primary Outcomes (1)

  • Primary Efficacy Outcome: Use of home dialysis

    Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).

    Use of home dialysis at six months after dialysis initiation

Secondary Outcomes (1)

  • Secondary outcome: Use of home dialysis at six months in patients who have been followed by a Nephrologist

    Use of home dialysis at six months after dialysis initiation in patients who have been followed by a Nephrologist

Study Arms (2)

Active KT Intervention

EXPERIMENTAL

CKD clinics receiving the active knowledge translation intervention.

Other: Active KT intervention

Usual standard of care

NO INTERVENTION

Clinics will continue their standard of care education and approach to use of home dialysis.

Interventions

Active KT interventionOTHER

1. Provider \& patient-directed infographics educating patients about home dialysis will be displayed in prominent clinic wall space 2. Educational white board presentations promoting home dialysis 3. Each clinic will receive reports outlining their current use of home dialysis in incident ESRD patients compared with provincial \& national averages 4. A Canadian version of the MATCH D tool will be provided to clinic staff, to help evaluate patient appropriateness for home dialysis. 5. Each clinic will receive an in-person visit from one of the study investigators/collaborators detailing the benefits of home dialysis, and the educational tools being offered to support care within their clinic.

Active KT Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multidisciplinary clinics in Canada that provide care coordinated by a Nephrologist to patients with chronic kidney disease (CKD). These clinics have already been identified in a previous survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • Manns BJ, Garg AX, Sood MM, Ferguson T, Kim SJ, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Dixon SN, Alam A, Allu S, Tangri N. Multifaceted Intervention to Increase the Use of Home Dialysis: A Cluster Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Apr;17(4):535-545. doi: 10.2215/CJN.13191021. Epub 2022 Mar 21.

    PMID: 35314481DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Navdeep Tangri, MD PhD FRCPC

    University of Manitoba

    STUDY DIRECTOR

  • Braden Manns, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 28, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2017

Study Completion

September 1, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

CA(2)