NCT01912001

Brief Summary

Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Patients with end stage renal disease, that is failure of the kidneys such that dialysis is required, are at high risk for adverse health events especially during a period of transition following a change in care settings. The investigators aim to implement a Home Dialysis Virtual Ward (HDVW) strategy of telephone follow-up, which is targeted to minimize gaps of care during transitions in care. The investigators aim to have clinicians follow patients by telephone if they meet one of the following four criteria;

  1. 1.Discharge from hospital.
  2. 2.Having an interventional procedure.
  3. 3.Prescription of an antibiotic.
  4. 4.Completion of Home Dialysis training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

7 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 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.2 years

First QC Date

July 22, 2013

Last Update Submit

May 10, 2016

Conditions

End Stage Renal DiseaseKidney FailureHome Dialysis

Keywords

end stage renal diseasekidney failurehome dialysishemodialysisperitoneal dialysisgaps in careco-morbiditytransitions of care settings

Outcome Measures

Primary Outcomes (1)

  • The number of care gaps identified.

    Up to 24 weeks post discharge from the virtual ward.

Secondary Outcomes (8)

  • Dialysis prescription and adherence.

    Up to 24 weeks.

  • Morbidity associated with dialysis therapy.

    Up to 24 weeks post discharge from the virtual ward.

  • Burden associated with travel time for patients.

    Up to 24 weeks post discharge from the virtual ward.

  • Medication reconciliation.

    Up to 24 weeks post discharge from the virtual ward.

  • Symptom management.

    Up to 24 weeks post discharge from the virtual ward.

  • +3 more secondary outcomes

Study Arms (1)

Telephone follow-up.

OTHER

A member of the Home Dialysis team will telephone patients to follow-up on their symptoms, dialysis and care.

Other: Telephone follow-upOther: Sympton Assessment

Interventions

Telephone follow-upOTHER
Telephone follow-up.
Sympton AssessmentOTHER
Telephone follow-up.

Eligibility Criteria

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

You may qualify if:

  • Patient in the home dialysis program (PD and HHD)and on of the following:
  • Discharge from hospital following an inpatient admissions
  • Medical procedure (e.g. vascular access procedure).
  • Treatment with antibiotics.
  • Completion of home dialysis training program.

You may not qualify if:

  • Decline consent.
  • Unable to participate - (e.g. no phone at home, language barrier)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alberta

Edmonton, Alberta, T6G 2V2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V6H 0A5, Canada

Location

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 1A2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • Schachter ME, Bargman JM, Copland M, Hladunewich M, Tennankore KK, Levin A, Oliver M, Pauly RP, Perl J, Zimmerman D, Chan CT. Rationale for a home dialysis virtual ward: design and implementation. BMC Nephrol. 2014 Feb 14;15:33. doi: 10.1186/1471-2369-15-33.

    PMID: 24528505DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christopher T Chan, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director-Nephrology/UHN

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 30, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

CA(7)