Cognitive ImpairmentNCT03408028
Therapeutic Intervention Code in a Cognitive Geriatric Unit
An observational study of Cognitive Impairment, run by Murielle Surquin at 1 site in Belgium.
Trial summary
The diagnostic and therapeutic progresses, associated with modifications in lifestyle and socio-cultural level of populations, have led to a remarkable increase in life expectancy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Medical File consultation
- How many people
- 310 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2017to 1 Oct 2017
- Phase
- Observational
- 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 65 years and older
- All sexes
- Older adult
Study population: Eldelry patients with cognitive imparement admitted in the geriatric unit 83 within the CHU Brugmann between 01-01-2016 and 31-12-2016.
Who may be able to join
- Elderly patients with cognitive impairment admitted in the geriatric unit 83 within the CHU Brugmann between 01-01-2016 and 31-12-2016.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Intervention Code in a Cognitive Geriatric Unit: Retrospective Analysis
The diagnostic and therapeutic progresses, associated with modifications in lifestyle and socio-cultural level of populations, have led to a remarkable increase in life expectancy. At the same time, the increasing medicalization of the individual has eroded the traditional boundaries between health and illness, normal and pathological state. This leads to the patient losing his sense of ownership of his own death. If most patients died at home before the Second World War, 75% of the population dies in hospital or institution at the present date.
Most hospitals and care institutions have developed codes, in multidisciplinary internal consultation, to address the interruption or lack of implementation of treatments that make no sense from a medical point of vue. This avoids therapeutic relentlessness.The code in place within the CHU Brugmann is:
Read more
- code A: no therapeutic restriction
- code B: not to be resuscitated
- code C: not to be intensively treated (no escalation in therapeutic treatments)
- code D: best palliative care (progressive de-escalation in therapeutic treatments).
These codes are established in consultation with the patient or his legal representative and are re-evaluated in a multidisciplinary way every week.
Planning a care path and therefore establishing a therapeutic code is particularly important for people with cognitive impairment and dementia because the progressive loss of cognitive abilities complicates the process of decision making.
A large part of the admissions are made via the emergency department. For these patients, no therapeutic plan has been established beforehand. However, the perception of the functional and cognitive status of the patient directly influences the intensity of care provided. Cognitive disorders are a risk factor for the exclusion of access to palliative care for the elderly patient.
The objectives of this study are:
- To establish a record of the therapeutic limitation codes in an acute cognitive geriatric unit
- To correlate the therapeutic limitation code with the comorbidities of the patients
- Conditions
- Cognitive Impairment
- Being tested
- Medical File consultation
- Keywords
- Therapeutic code, Geriatry
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical File consultationOther
Medical File consultation
| Study group | Role | What they receive |
|---|---|---|
| Cognitive impairment | Geriatric patients with a cognitive impairment Receives: Other: Medical File consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic code
Therapeutic code
Measured: From 01-01-2016 till 31-12-2016
Cumulative Illness Rating Scale for Geriatrics
This scoring system measures the chronic medical illness ("morbidity") burden while taking into consideration the severity of chronic diseases in 14 items representing individual body systems. The cumulative final score can theoretically vary from 0 to 56.
Measured: From 01-01-2016 till 31-12-2016
Secondary outcomes (3)
Age
Age
Measured: From 01-01-2016 till 31-12-2016
Sex
Sex
Measured: From 01-01-2016 till 31-12-2016
Ethnicity
Ethnicity
Measured: From 01-01-2016 till 31-12-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Apr 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murielle Surquin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murielle Surquin, Brugmann University Hospital
- Investigators
- Carolina Natalia Grande Pérez, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408028
- Sponsor's protocol ID
- CHUB- status code
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Intervention Code in a Cognitive Geriatric Unit: Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03408028
- Acronym / sponsor ID
- CHUB- status code
- Conditions
- Cognitive Impairment
- Keywords
- Therapeutic code, Geriatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Murielle SurquinUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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 diagnostic and therapeutic progresses, associated with modifications in lifestyle and socio-cultural level of populations, have led to a remarkable increase in life expectancy. At the same time, the increasing medicalization of the individual has eroded the traditional boundaries between health and illness, normal and pathological state. This leads to the patient losing his sense of ownership of his own death. If most patients died at home before the Second World War, 75% of the population dies in hospital or institution at the present date.
Most hospitals and care institutions have developed codes, in multidisciplinary internal consultation, to address the interruption or lack of implementation of treatments that make no sense from a medical point of vue. This avoids therapeutic relentlessness.The code in place within the CHU Brugmann is:
- code A: no therapeutic restriction
- code B: not to be resuscitated
- code C: not to be intensively treated (no escalation in therapeutic treatments)
- code D: best palliative care (progressive de-escalation in therapeutic treatments).
These codes are established in consultation with the patient or his legal representative and are re-evaluated in a multidisciplinary way every week.
Planning a care path and therefore establishing a therapeutic code is particularly important for people with cognitive impairment and dementia because the progressive loss of cognitive abilities complicates the process of decision making.
A large part of the admissions are made via the emergency department. For these patients, no therapeutic plan has been established beforehand. However, the perception of the functional and cognitive status of the patient directly influences the intensity of care provided. Cognitive disorders are a risk factor for the exclusion of access to palliative care for the elderly patient.
The objectives of this study are:
- To establish a record of the therapeutic limitation codes in an acute cognitive geriatric unit
- To correlate the therapeutic limitation code with the comorbidities of the patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive impairment | – | Other: Medical File consultationGeriatric patients with a cognitive impairment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Eldelry patients with cognitive imparement admitted in the geriatric unit 83 within the CHU Brugmann between 01-01-2016 and 31-12-2016.
Key inclusion criteria (1 listed)
- Elderly patients with cognitive impairment admitted in the geriatric unit 83 within the CHU Brugmann between 01-01-2016 and 31-12-2016.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Medical File consultationMedical File consultation | Other | Cognitive impairment |
Primary outcome
Therapeutic code
Time frame: From 01-01-2016 till 31-12-2016
Therapeutic code
Cumulative Illness Rating Scale for Geriatrics
Time frame: From 01-01-2016 till 31-12-2016
This scoring system measures the chronic medical illness ("morbidity") burden while taking into consideration the severity of chronic diseases in 14 items representing individual body systems. The cumulative final score can theoretically vary from 0 to 56.
3 secondary outcomes
Age
Time frame: From 01-01-2016 till 31-12-2016
Sex
Time frame: From 01-01-2016 till 31-12-2016
Ethnicity
Time frame: From 01-01-2016 till 31-12-2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Cognitive Impairment
Not yet recruiting
Supplementation of Inulin + L. Acidophilus in Elders With T2DM
Diabetes Mellitus, Microbiome
Not yet recruiting
Negotiation Training for Family Caregivers of People With Alzheimer's Disease
Alzheimer's Disease (AD), Dementia
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
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.
Carolina Natalia Grande Pérez, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by Murielle Surquin at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2018. 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 Belgium. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Therapeutic code (time frame: From 01-01-2016 till 31-12-2016). The study lists 2 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 23 Jan 2018.