End Stage Renal FailureNCT01834755
Physical and Psychological Profiles Associated With Patient's Preference for ESRD Treatment
A study testing Evaluation of psychological phenotype in people with End Stage Renal Failure, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Highlighting the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure
- What is being tested?
- Evaluation of psychological phenotype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to 27 Jun 2013
- 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
- More than 18 years
- CKD with estimated GFR below 20 ml/min/1.73m2 without dialysis treatment
- Patient who accepts information delivery about treatments of ESRF
- Patient who accepted and signed the informed consent
- Subject beneficiary of a social security system
Who cannot join
- Inability to achieve psychological tests
- Inability to achieve physical tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy
Highlighting the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.
Read the detailed description
CKD is a Public Health Problem with a prevalence of 10% in general population. For patients reaching The making decision to treat ESRD with renal replacement therapy is a complex process and needs to be shared between patients, family, physician and nephrologist.
Systematic Information delivery about several treatments of ESRD is recommended for patients and his family (Hemodialysis, Peritoneal Dialysis, Kidney Transplantation and Conservative treatment). Some studies on the preference of patients for renal replacement therapy reported a choice for PD about 50% while the registers report a low diffusion of PD (around 10%). Since 2009 we propose a systematic information about the different therapeutic options for ESRD and identified some clinical characteristics associated to patient's preference. However we want to know if psychological or physical phenotype is associated to patient's preference.
The objective of the study is to highlight the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.
- Conditions
- End Stage Renal Failure
- Being tested
- Evaluation of psychological phenotype
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of psychological phenotypeOther
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | Evaluation of psychological phenotype with several questionnaire (Big Five, EPADV-16), physical activity with a self-administered questionnaire (Baecke) and several test ( SPPB, Handgrip Strengh test, MicroFET 2 Digital Dynamometer) Receives: Other: Evaluation of psychological phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of different psychological and physical characteristics according to patients preference
The measure is composite:
criteria evaluated for psychological phenotype are: The score of the Big Five test Scale Assess people's perception of autonomy in various life domains (EPADV-16)
The criteria evaluated for physical phenotype are:
- Global physical activity assess with self-administered questionnaire of BAECKE.
- Evaluation of mobility with Short Physical Performance Battery Score (SPPB)
- Measure of the maximum isometric strenght of the hand with " Handgrip Strengh test"
- Assessment of musculoskeletal testing of the leg with MicroFET 2 Digital Dynamometer
Measured: one day
Secondary outcomes (1)
Clinical characteristics and laboratory values
Clinical characteristics (age, sex, way of life, education level, QOL, nephropathy, cardio-vascular comorbidity) and laboratory values (haemoglobin, ferritin, css, creatinine, cystatin C, phosphates, calcium, 25OHD3, PTH and CRP) associated with psychological or physical phenotypes.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completion27 Jun 2013
- Study completion27 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier MORANNE, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834755
- Sponsor's protocol ID
- 12-AOI-03
- Status last verified
- Nov 2023
- First submitted
- 13 Feb 2013
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01834755
- Acronym / sponsor ID
- 12-AOI-03
- Conditions
- End Stage Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 27 Jun 2013 (actual)
- Study completion
- 27 Jun 2013 (actual)
- First posted
- 18 Apr 2013 (estimated)
- 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.
Highlighting the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.
Detailed description
CKD is a Public Health Problem with a prevalence of 10% in general population. For patients reaching The making decision to treat ESRD with renal replacement therapy is a complex process and needs to be shared between patients, family, physician and nephrologist.
Systematic Information delivery about several treatments of ESRD is recommended for patients and his family (Hemodialysis, Peritoneal Dialysis, Kidney Transplantation and Conservative treatment). Some studies on the preference of patients for renal replacement therapy reported a choice for PD about 50% while the registers report a low diffusion of PD (around 10%). Since 2009 we propose a systematic information about the different therapeutic options for ESRD and identified some clinical characteristics associated to patient's preference. However we want to know if psychological or physical phenotype is associated to patient's preference.
The objective of the study is to highlight the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: Evaluation of psychological phenotypeEvaluation of psychological phenotype with several questionnaire (Big Five, EPADV-16), physical activity with a self-administered questionnaire (Baecke) and several test ( SPPB, Handgrip Strengh test, MicroFET 2 Digital Dynamometer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- More than 18 years
- CKD with estimated GFR below 20 ml/min/1.73m2 without dialysis treatment
- Patient who accepts information delivery about treatments of ESRF
- Patient who accepted and signed the informed consent
- Subject beneficiary of a social security system
Key exclusion criteria (2 listed)
- Inability to achieve psychological tests
- Inability to achieve physical tests
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 |
|---|---|---|
| Evaluation of psychological phenotype | Other | single arm |
Primary outcome
Comparison of different psychological and physical characteristics according to patients preference
Time frame: one day
The measure is composite: criteria evaluated for psychological phenotype are: The score of the Big Five test Scale Assess people's perception of autonomy in various life domains (EPADV-16) The criteria evaluated for physical phenotype are: * Global physical activity assess with self-administered questionnaire of BAECKE. * Evaluation of mobility with Short Physical Performance Battery Score (SPPB) * Measure of the maximum isometric strenght of the hand with " Handgrip Strengh test" * Assessment of musculoskeletal testing of the leg with MicroFET 2 Digital Dynamometer
1 secondary outcome
Clinical characteristics and laboratory values
Time frame: one day
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 18 Nov 2023.
Related trials for End Stage Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Olivier MORANNE, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of psychological phenotype in people with End Stage Renal Failure, run by Centre Hospitalier Universitaire de Nice 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 5 inclusion and 2 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 18 Nov 2023. 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?
Comparison of different psychological and physical characteristics according to patients preference (time frame: one day). 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 18 Nov 2023.