Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Aged Clinical Trial

— BCDE  

Official title:

Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01225458
• Other study ID #: BCDE
• Status: Terminated
• Phase: N/A
• First received: October 20, 2010
• Last updated: September 14, 2016
• Start date: July 2008
• Est. completion date: January 2015

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.

The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion criteria :

• Patients aged of 75 years old or more,

• Chronic kidney disease stage 5 defined by :

• either an estimated GFR (MDRD) = 15ml/mn/1,73 m² in a non-dialysis patient with a nephrology follow-up > 3 months ("Pre-dialysis cohort"),

• or a dialysis treatment started for more than 3 months and less than one year, after a pre-dialysis follow-up > 3 months ("post-dialysis cohort"),

• Signed and dated informed consent.

Exclusion criteria :

• Moderately severe to severe dementia (MMS = 15),

• Major depression and/or GDS-15 > 10/15,

• Severe dependency (ADL < 3/6).,

• Psychosis, mutism or aphasia,

• Malignancy or any pathology with life expectancy < one year.

• Ongoing specialized geriatric care

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aged
• Chronic Kidney Failure
• Chronic Renal Insufficiency
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• shorter tests
Geriatric evaluation with MMS, GDS and ADL scoring
• initial complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
• follow-up complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years

Locations

Country	Name	City	State
France	CHU de Nice	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	death		every 6 month for 3 years since inclusion	Yes
Primary	occurrence of a severe dementia (MMS < 10)		every 6 month for 3 years since inclusion	Yes
Primary	major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria		every 6 month for 3 years since inclusion	Yes
Primary	severe dependency (ADL < 3/6)		every 6 month for 3 years since inclusion	Yes
Secondary	cognitive, psychic and autonomy scores		every 6 month for 3 years since inclusion	Yes
Secondary	cardiovascular morbidity and mortality		every 6 month for 3 years since inclusion	Yes
Secondary	bone fracture		every 6 month for 3 years since inclusion	Yes
Secondary	nutritional parameters		every 6 month for 3 years since inclusion	Yes
Secondary	dialysis parameters		every 6 month for 3 years since inclusion	No
Secondary	biological follow-up of chronic kidney disease including haemoglobin level		every 6 month for 3 years since inclusion	Yes