HemolysisDIADIDEALNCT03633435
Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation
A study testing assisted home hemodialysis patients in people with Hemolysis and Cannulation, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemolysis, Cannulation, Arteriovenous Fistula
- What is being tested?
- assisted home hemodialysis patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2019to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- medical contra-indication for HHD
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
caen University hospital
Caen, 14000
Clémence Béchade, PhD, +33231272575, bechade-c@chu-caen.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemolysis, Cannulation, Arteriovenous Fistula, Nurse's Role
- Being tested
- assisted home hemodialysis patients
- Medical subject headings
- Hemolysis, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assisted home hemodialysis patientsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| assisted home hemodialysis patients | Experimental | all patients starting assisted home hemodialysis during the study period Receives: Procedure: assisted home hemodialysis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of assisted- HDD
definitive cessation of HHD with transfer to an other dialysis modality.
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start21 Mar 2019
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- NxStage Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633435
- Sponsor's protocol ID
- 2018-A00992-53
- Acronym
- DIADIDEAL
- Status last verified
- Feb 2021
- First submitted
- 13 Aug 2018
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation
- ClinicalTrials.gov ID
- NCT03633435
- Acronym / sponsor ID
- DIADIDEAL / 2018-A00992-53
- Conditions
- Hemolysis, Cannulation, Arteriovenous Fistula, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- NxStage Medical
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| assisted home hemodialysis patients | Experimental | Procedure: assisted home hemodialysis patientsall patients starting assisted home hemodialysis during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- medical contra-indication for HHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assisted home hemodialysis patientsArteriovenous 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 | Procedure or surgery | assisted home hemodialysis patients |
Primary outcome
failure of assisted- HDD
Time frame: 12months
definitive cessation of HHD with transfer to an other dialysis modality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assisted home hemodialysis patients in people with Hemolysis and Cannulation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure of assisted- HDD (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.