NCT03633435

Brief Summary

Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 21, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

2.6 years

First QC Date

August 13, 2018

Last Update Submit

February 25, 2021

Conditions

HemolysisCannulationArteriovenous FistulaNurse's Role

Outcome Measures

Primary Outcomes (1)

  • failure of assisted- HDD

    definitive cessation of HHD with transfer to an other dialysis modality.

    12months

Study Arms (1)

assisted home hemodialysis patients

EXPERIMENTAL

all patients starting assisted home hemodialysis during the study period

Procedure: assisted home hemodialysis patients

Interventions

assisted home hemodialysis patientsPROCEDURE

Arteriovenous fistula cannulation at the patient's home provided by a trained private nurse at each dialysis session with the rope-ladder technique, and connection to the Nxstage System One

assisted home hemodialysis patients

Eligibility Criteria

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

You may qualify if:

  • The patient must be aged more than 18, able to read and write, and have a person with him at home during HD session, according to the french law.

You may not qualify if:

  • medical contra-indication for HHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

caen University hospital

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

HemolysisArteriovenous Fistula

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All incident and prevalent dialysis patients of our unit will get information on that assisted HHD program and will be able to choose this technique
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 16, 2018

Study Start

March 21, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

FR(1)