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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01834755
Enrollment
60
Registered
2013-04-18
Start date
2013-02-28
Completion date
2013-06-27
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Failure

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.

Interventions

OTHEREvaluation of psychological phenotype

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of different psychological and physical characteristics according to patients preferenceone dayThe 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

MeasureTime frameDescription
Clinical characteristics and laboratory valuesone dayClinical 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026