Peritoneal DialysisDEXTERNCT03900819
Evaluation of Dexterity in Prevalent Peritoneal Dialysis Patients
An observational study of Peritoneal Dialysis, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- dexterity measurement
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Nov 2019
- Phase
- Observational
- 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
Study population: All prevalent PD patients from our center will be included
Who may be able to join
- patients treated by peritoneal dialysis in Caen University Hospital
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Manual Dexterity in a Monocentric Cohort of Peritoneal Dialysis Patients
The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study
Read the detailed description
All peritoneal dialysis patients from Peritoneal Dialysis unit will, after information and consent, have to realise four tests, one time each, to quantify their manual dexterity. The tests are already used to measure dexterity: Purdue Pegboard, Jebsen test, JAMAR, Pinch test. These tests will be performed during an in-hospital visit.
- Conditions
- Peritoneal Dialysis
- Being tested
- dexterity measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexterity measurementOther
4 non-invasive tests will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
success of dexterity measurement in peritoneal dialysis patients evaluated by the Purdue Pegboard
number of completed tests (Purdue Pegboard - number inserted in 30 second)
Measured: baseline
success of dexterity measurement in peritoneal dialysis patients evaluated by the Jebsen test
number of completed tests (Jebsen test - time in second)
Measured: baseline
success of dexterity measurement in peritoneal dialysis patients evaluated by the JAMAR
number of completed tests (JAMAR - in kilogramms)
Measured: baseline
success of dexterity measurement in peritoneal dialysis patients evaluated by the Pinch test
number of completed tests (Pinch testin - kilogramms)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900819
- Sponsor's protocol ID
- 2018-A01523-52
- Acronym
- DEXTER
- Status last verified
- Jan 2020
- First submitted
- 20 Sep 2018
- Last updated
- 23 Jan 2020
- 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 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Manual Dexterity in a Monocentric Cohort of Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT03900819
- Acronym / sponsor ID
- DEXTER / 2018-A01523-52
- Conditions
- Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 3 Apr 2019 (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.
The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study
Detailed description
All peritoneal dialysis patients from Peritoneal Dialysis unit will, after information and consent, have to realise four tests, one time each, to quantify their manual dexterity. The tests are already used to measure dexterity: Purdue Pegboard, Jebsen test, JAMAR, Pinch test. These tests will be performed during an in-hospital visit.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All prevalent PD patients from our center will be included
Key inclusion criteria (1 listed)
- patients treated by peritoneal dialysis in Caen University Hospital
Key exclusion criteria (1 listed)
- refusal to participate
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 |
|---|---|---|
| dexterity measurement4 non-invasive tests will be performed | Other | – |
Primary outcome
success of dexterity measurement in peritoneal dialysis patients evaluated by the Purdue Pegboard
Time frame: baseline
number of completed tests (Purdue Pegboard - number inserted in 30 second)
success of dexterity measurement in peritoneal dialysis patients evaluated by the Jebsen test
Time frame: baseline
number of completed tests (Jebsen test - time in second)
success of dexterity measurement in peritoneal dialysis patients evaluated by the JAMAR
Time frame: baseline
number of completed tests (JAMAR - in kilogramms)
success of dexterity measurement in peritoneal dialysis patients evaluated by the Pinch test
Time frame: baseline
number of completed tests (Pinch testin - kilogramms)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Peritoneal Dialysis
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis, 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: finished, as of the sponsor's last update on 23 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of dexterity measurement in peritoneal dialysis patients evaluated by the Purdue Pegboard (time frame: baseline). The study lists 4 primary outcomes in all. 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 23 Jan 2020.