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

End Stage Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834755
• Other study ID #: 12-AOI-03
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: June 27, 2013

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 27, 2013
• Est. primary completion date: June 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Failure
• Kidney Failure, Chronic

Intervention

Other:
• Evaluation of psychological phenotype

Locations

Country	Name	City	State
France	CHU de Nice - Service de Néphrologie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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