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

Primary Purpose

Hemolysis, Cannulation, Arteriovenous Fistula

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
assisted home hemodialysis patients
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • caen University hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

assisted home hemodialysis patients

Arm Description

all patients starting assisted home hemodialysis during the study period

Outcomes

Primary Outcome Measures

failure of assisted- HDD
definitive cessation of HHD with transfer to an other dialysis modality.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2018
Last Updated
February 25, 2021
Sponsor
University Hospital, Caen
Collaborators
NxStage Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03633435
Brief Title
Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation
Acronym
DIADIDEAL
Official Title
Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
NxStage Medical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemolysis, Cannulation, Arteriovenous Fistula, Nurse's Role

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
assisted home hemodialysis patients
Arm Type
Experimental
Arm Description
all patients starting assisted home hemodialysis during the study period
Intervention Type
Procedure
Intervention Name(s)
assisted home hemodialysis patients
Intervention Description
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
Primary Outcome Measure Information:
Title
failure of assisted- HDD
Description
definitive cessation of HHD with transfer to an other dialysis modality.
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
caen University hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clémence Béchade, PhD
Phone
+33231272575
Email
bechade-c@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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