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

Overview

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.

Full Title of Study: “Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 27, 2013

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.

Interventions

  • Other: Evaluation of psychological phenotype

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Clinical characteristics and laboratory values
    • Time Frame: one day
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nice
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Olivier MORANNE, MD, Principal Investigator, Centre Hospitalier Universitaire de Nice

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