Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation (DIADIDEAL)

February 25, 2021 updated by: University Hospital, Caen

Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Monocentric prospective interventional study.
  • Intervention is assisted HHD, defined as: rope-ladder cannulation at the patient's home provided by a trained private nurse at each dialysis session, and connection to the Nxstage System One
  • pilot study, with main objective defined as feasibility of the investigator's assisted HHD program. Pilot study usually concerns a small population, allowing us to develop thereafter a bigger study if the results are encouraging.
  • primary end-point criteria defined as definitive cessation of HHD with transfer to an other dialysis modality.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • CAEN University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • medical contra-indication for HHD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: assisted home hemodialysis patients
all patients starting assisted home hemodialysis during the study period
Procedure: assisted home hemodialysis patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
failure of assisted- HDD
Time Frame: 12months
definitive cessation of HHD with transfer to an other dialysis modality.
12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

NxStage Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A00992-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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