Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE) - Full Text View

Purpose

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.

Condition	Intervention
Chronic Renal Insufficiency Chronic Kidney Failure Aged	Other: shorter tests Other: initial complete geriatric tests Other: follow-up complete geriatric tests

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Dementia Depression Dialysis Kidney Failure

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

death [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
occurrence of a severe dementia (MMS < 10) [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
severe dependency (ADL < 3/6) [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

cognitive, psychic and autonomy scores [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
cardiovascular morbidity and mortality [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
bone fracture [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
nutritional parameters [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
dialysis parameters [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: No ]
biological follow-up of chronic kidney disease including haemoglobin level [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: exclusive nephrology follow-up 250 patients will be included and randomized in the "exclusive nephrology follow-up" arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. In addition to their nephrology consultations, patients will benefit from a geriatric evaluation with MMS, GDS and ADL scoring.	Other: shorter tests Geriatric evaluation with MMS, GDS and ADL scoring Other: initial complete geriatric tests evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
Experimental: geriatric follow-up 250 patients will be included and randomized in the "geriatric follow-up" arm. They will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. About geriatric evaluation Patients randomized in this arm will also have more complete tests to evaluate cognitive functions (memory, language and movements), psychological functions (depression and anxiety) and dependency in activities of daily living. Other tests will allow evaluate vision, audition, mobility and nutritional status.	Other: shorter tests Geriatric evaluation with MMS, GDS and ADL scoring Other: initial complete geriatric tests evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit Other: 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

Arms

Assigned Interventions

Placebo Comparator: exclusive nephrology follow-up

250 patients will be included and randomized in the "exclusive nephrology follow-up" arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. In addition to their nephrology consultations, patients will benefit from a geriatric evaluation with MMS, GDS and ADL scoring.

Other: shorter tests

Geriatric evaluation with MMS, GDS and ADL scoring

Other: initial complete geriatric tests

evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit

Experimental: geriatric follow-up

250 patients will be included and randomized in the "geriatric follow-up" arm. They will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients.

About geriatric evaluation Patients randomized in this arm will also have more complete tests to evaluate cognitive functions (memory, language and movements), psychological functions (depression and anxiety) and dependency in activities of daily living. Other tests will allow evaluate vision, audition, mobility and nutritional status.

Other: shorter tests

Geriatric evaluation with MMS, GDS and ADL scoring

Other: initial complete geriatric tests

evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit

Other: 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

Eligibility

Ages Eligible for Study:	75 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225458

Contacts

Contact: Vincent ESNAULT, Pr.

33(0)492038876

esnault.v@chu-nice.fr

Locations

France
CHU de Nice	Recruiting
Nice, France, 06000
Contact: Vincent ESNAULT, Pr. 33(0)492038876 esnault.v@chu-nice.fr
Principal Investigator: Vincent ESNAULT, Pr.
Sub-Investigator: Olivier MORANNE, Dr.
Sub-Investigator: Guillaume FAVRE, Dr.
Sub-Investigator: Mohamed Shariful ISLAM, Dr.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

More Information

No publications provided

Responsible Party:	Departement de la Recherche Clinique et de l'Innovation, CENTRE HOSPITALIER UNIVERSITAIRE DE NICE
ClinicalTrials.gov Identifier:	NCT01225458 History of Changes
Other Study ID Numbers:	BCDE
Study First Received:	October 20, 2010
Last Updated:	October 20, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:

Elderly patients
renal insufficiency
systematized gerontologic evaluation

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013