Chronic Renal InsufficiencyBCDENCT01225458
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
A study testing shorter tests, initial complete geriatric tests and follow-up complete geriatric tests in people with Chronic Renal Insufficiency and Chronic Kidney Failure, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Chronic Renal Insufficiency, Chronic Kidney Failure, Aged
- What is being tested?
- shorter tests, initial complete geriatric tests and follow-up complete geriatric tests
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Renal Insufficiency, Chronic Kidney Failure, Aged
- Being tested
- shorter tests, initial complete geriatric tests, follow-up complete geriatric tests
- Keywords
- Elderly patients, renal insufficiency, systematized gerontologic evaluation
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shorter testsOther
Geriatric evaluation with MMS, GDS and ADL scoring
initial complete geriatric testsOther
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
follow-up complete geriatric testsOther
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years
| Study group | Role | What they receive |
|---|---|---|
| exclusive nephrology follow-up | Placebo comparator | 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. Receives: Other: shorter tests; Other: initial complete geriatric tests |
| geriatric follow-up | Experimental | 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. Receives: Other: shorter tests; Other: initial complete geriatric tests; Other: follow-up complete geriatric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: every 6 month for 3 years since inclusion
occurrence of a severe dementia (MMS < 10)
Measured: every 6 month for 3 years since inclusion
major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria
Measured: every 6 month for 3 years since inclusion
severe dependency (ADL < 3/6)
Measured: every 6 month for 3 years since inclusion
Secondary outcomes (6)
cognitive, psychic and autonomy scores
Measured: every 6 month for 3 years since inclusion
cardiovascular morbidity and mortality
Measured: every 6 month for 3 years since inclusion
bone fracture
Measured: every 6 month for 3 years since inclusion
nutritional parameters
Measured: every 6 month for 3 years since inclusion
dialysis parameters
Measured: every 6 month for 3 years since inclusion
biological follow-up of chronic kidney disease including haemoglobin level
Measured: every 6 month for 3 years since inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startJul 2008
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225458
- Sponsor's protocol ID
- BCDE
- Acronym
- BCDE
- Status last verified
- Sep 2016
- First submitted
- 20 Oct 2010
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
- ClinicalTrials.gov ID
- NCT01225458
- Acronym / sponsor ID
- BCDE / BCDE
- Conditions
- Chronic Renal Insufficiency, Chronic Kidney Failure, Aged
- Keywords
- Elderly patients, renal insufficiency, systematized gerontologic evaluation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exclusive nephrology follow-up | Placebo comparator | Other: shorter tests, Other: initial complete geriatric tests250 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. |
| geriatric follow-up | Experimental | Other: shorter tests, Other: initial complete geriatric tests, Other: follow-up complete geriatric tests250 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shorter testsGeriatric evaluation with MMS, GDS and ADL scoring | Other | exclusive nephrology follow-up, geriatric follow-up |
| initial complete geriatric testsevaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit | Other | exclusive nephrology follow-up, geriatric follow-up |
| follow-up complete geriatric testsevaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years | Other | geriatric follow-up |
Primary outcome
death
Time frame: every 6 month for 3 years since inclusion
occurrence of a severe dementia (MMS < 10)
Time frame: every 6 month for 3 years since inclusion
major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria
Time frame: every 6 month for 3 years since inclusion
severe dependency (ADL < 3/6)
Time frame: every 6 month for 3 years since inclusion
6 secondary outcomes
cognitive, psychic and autonomy scores
Time frame: every 6 month for 3 years since inclusion
cardiovascular morbidity and mortality
Time frame: every 6 month for 3 years since inclusion
bone fracture
Time frame: every 6 month for 3 years since inclusion
nutritional parameters
Time frame: every 6 month for 3 years since inclusion
dialysis parameters
Time frame: every 6 month for 3 years since inclusion
biological follow-up of chronic kidney disease including haemoglobin level
Time frame: every 6 month for 3 years since inclusion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shorter tests, initial complete geriatric tests and follow-up complete geriatric tests in people with Chronic Renal Insufficiency and Chronic Kidney Failure, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: every 6 month for 3 years since inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.