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
About this trial
This is an interventional treatment trial for Hemolysis
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
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
NCT ID
NCT03633435
First Posted
August 13, 2018
Last Updated
February 25, 2021
Sponsor
University Hospital, Caen
Collaborators
NxStage Medical
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
Learn more about this trial
Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation
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