NCT01834755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2013

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

February 13, 2013

Last Update Submit

November 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical characteristics and laboratory values

    one day

Study Arms (1)

single arm

OTHER

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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to achieve psychological tests
  • Inability to achieve physical tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - Service de Néphrologie

Nice, 06000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier MORANNE, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

April 18, 2013

Study Start

February 1, 2013

Primary Completion

June 27, 2013

Study Completion

June 27, 2013

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations