Physical and Psychological Profiles Associated With Patient's Preference for ESRD Treatment
Primary Purpose
End Stage Renal Failure
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of psychological phenotype
Sponsored by
About this trial
This is an interventional health services research trial for End Stage Renal Failure
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to achieve psychological tests
- Inability to achieve physical tests
Sites / Locations
- CHU de Nice - Service de NéphrologieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single arm
Arm Description
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01834755
First Posted
February 13, 2013
Last Updated
April 16, 2013
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01834755
Brief Title
Physical and Psychological Profiles Associated With Patient's Preference for ESRD Treatment
Official Title
Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Evaluation of psychological phenotype
Primary Outcome Measure Information:
Title
Comparison of different psychological and physical characteristics according to patients preference
Description
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
Time Frame
one day
Secondary Outcome Measure Information:
Title
Clinical characteristics and laboratory values
Description
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.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Inability to achieve psychological tests
Inability to achieve physical tests
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier MORANNE, MD
Phone
33492038584
Email
moranne.o@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier MORANNE, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Service de Néphrologie
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MORANNE, MD
Phone
33492038584
Email
moranne.o@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Olivier MORANNE, MD
12. IPD Sharing Statement
Learn more about this trial
Physical and Psychological Profiles Associated With Patient's Preference for ESRD Treatment
We'll reach out to this number within 24 hrs