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NCT03633435 Clinical Trial

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

Nurse's Role Clinical Trial

— DIADIDEAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03633435
Other study ID # 2018-A00992-53
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2019
Est. completion date November 2022

Study information
Verified date February 2021
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date November 2022
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France caen University hospital Caen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Caen NxStage Medical

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary failure of assisted- HDD definitive cessation of HHD with transfer to an other dialysis modality. 12months
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