Physical and Psychological Profiles Associated With Patient's Preference for ESRD Treatment

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Failure
• Intervention / Treatment: Other: Evaluation of psychological phenotype

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier MORANNE, MD; Phone Number: 33492038584; Email: moranne.o@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice - Service de Néphrologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single arm; 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)	Other: Evaluation of psychological phenotype

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Olivier MORANNE, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 27, 2013
• Study Completion (Actual): June 27, 2013

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (Estimated): April 18, 2013

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 12-AOI-03