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NCT Number: NCT01834755

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of psychological phenotype

Other

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2013
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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