DeliriumDETEcTNCT02086981
The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma
An observational study of Delirium and Bone Fractures, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Bone Fractures, Multiple Trauma
- How many people
- 672 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Jan 2015
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Older adult
Study population: Patients admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase
Who may be able to join
- Patients with any medical condition with an age of 65 years and older
Who cannot join
- Impossibility to give an informed consent; refusal
Trial locations and contacts
1 site in 1 country.
About this study
Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.
Read the detailed description
The aging of population as well as the increased life expectancy put progressively urgent demands about the adequacy of the level of care provided in a hospital environment to ensure clinical pathways tailored on the needs of each individual patient. On the other hand, the gradual evolution of Health Care systems to care for the acute, with increasing levels of specialization often technologically driven, cannot and must not neglect these aspects of personalization of care protecting the elderly "frail" patient, because of its intrinsic characteristics. In such a context, evaluation of frailty undertakes not only the meaning of prevention and promotion of quality of life but it takes in account important issues for patient's safety and the economic weight it entails. Delirium (acute confusional state) is a complex syndrome which frequently occurs in the elderly hospitalized population. Development of Delirium is associated with negative outcomes such as a longer hospital stay, a higher rate of complications, cognitive and functional decline, loss of independence, institutionalization, and, ultimately, death. For skilled healthcare professionals, on the other hand, it represents a challenging condition because a prompt and accurate diagnosis with the introduction of all those prevention and non-pharmacological measures may reduce the incidence, severity and/or duration of Delirium and improve functional recovery. Therefore the meaning of conducting such an observational study is also to provide evidence of patients' needs and address the on-ground educational aspect for healthcare professionals in a daily practice. The purposes of the study are to determine the incidence and prevalence (before and after surgery) of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase as well as to determine the risk factors for developing such a condition. Secondary objectives are mean hospital stay, rates of complications as well as in-hospital mortality and at 1, 3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 months follow-up.
- Conditions
- Delirium, Bone Fractures, Multiple Trauma
- Medical subject headings
- Delirium, Fractures, Bone, Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Delirium, its association with risk factors and their prognostic value
Patients are evaluated on admission with:
- IqCode
- Katz Index of Independence in Activities of Daily Living (ADL)
- The Lawton Instrumental Activities of Daily Living (IADL) Scale
- The Barthel Index for Mobility
- The Confusion Assessment Method (CAM)
- The 4AT Scale
- Presence of Risk Factors
Measured: At hospital admission
Incidence of Delirium, its association with risk factors and their prognostic value
Detection of any change in clinical condition. Patients are evaluated with:
- The Confusion Assessment Method (CAM)
- The 4AT Scale
Measured: At hospital admission and for the next 48 hours
Incidence of Delirium, its association with risk factors and their prognostic value
Detection of any change in clinical condition. Patients are evaluated with:
- The Confusion Assessment Method (CAM)
- The 4AT Scale
Measured: After surgery and for the next 48 hours
Secondary outcomes (5)
Mortality rates
Measured: In-Hospital
Mortality rates
Measured: At 1,3 and 12 months follow-up
Mean Hospital Stay
Measured: In-Hospital
Clinical Complications
Measured: In-Hospital
Changes in functional capabilities
Patients are evaluated with:
- Katz Index of Independence in Activities of Daily Living (ADL)
- The Lawton Instrumental Activities of Daily Living (IADL) Scale
- The Barthel Index for Mobility
Measured: At 1, 3 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startFeb 2014
- 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 DeliriumStudies 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
- Prospective
- Enrolment
- 672 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Cartei, MD, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Marco Mannucci, MD, Study director, Azienda Ospedaliero-Universitaria CareggiAlessandro Cartei, MD, Principal investigator, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086981
- Sponsor's protocol ID
- OSS.13.070
- Other IDs
- OSS.13.070
- Acronym
- DETEcT
- Status last verified
- Dec 2015
- First submitted
- 22 Feb 2014
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma
- ClinicalTrials.gov ID
- NCT02086981
- Acronym / sponsor ID
- DETEcT / OSS.13.070
- Conditions
- Delirium, Bone Fractures, Multiple Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Mar 2014 (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.
Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.
Detailed description
The aging of population as well as the increased life expectancy put progressively urgent demands about the adequacy of the level of care provided in a hospital environment to ensure clinical pathways tailored on the needs of each individual patient. On the other hand, the gradual evolution of Health Care systems to care for the acute, with increasing levels of specialization often technologically driven, cannot and must not neglect these aspects of personalization of care protecting the elderly "frail" patient, because of its intrinsic characteristics. In such a context, evaluation of frailty undertakes not only the meaning of prevention and promotion of quality of life but it takes in account important issues for patient's safety and the economic weight it entails. Delirium (acute confusional state) is a complex syndrome which frequently occurs in the elderly hospitalized population. Development of Delirium is associated with negative outcomes such as a longer hospital stay, a higher rate of complications, cognitive and functional decline, loss of independence, institutionalization, and, ultimately, death. For skilled healthcare professionals, on the other hand, it represents a challenging condition because a prompt and accurate diagnosis with the introduction of all those prevention and non-pharmacological measures may reduce the incidence, severity and/or duration of Delirium and improve functional recovery. Therefore the meaning of conducting such an observational study is also to provide evidence of patients' needs and address the on-ground educational aspect for healthcare professionals in a daily practice. The purposes of the study are to determine the incidence and prevalence (before and after surgery) of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase as well as to determine the risk factors for developing such a condition. Secondary objectives are mean hospital stay, rates of complications as well as in-hospital mortality and at 1, 3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 months follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase
Key inclusion criteria (1 listed)
- Patients with any medical condition with an age of 65 years and older
Key exclusion criteria (1 listed)
- Impossibility to give an informed consent; refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Delirium, its association with risk factors and their prognostic value
Time frame: At hospital admission
Patients are evaluated on admission with: * IqCode * Katz Index of Independence in Activities of Daily Living (ADL) * The Lawton Instrumental Activities of Daily Living (IADL) Scale * The Barthel Index for Mobility * The Confusion Assessment Method (CAM) * The 4AT Scale * Presence of Risk Factors
Incidence of Delirium, its association with risk factors and their prognostic value
Time frame: At hospital admission and for the next 48 hours
Detection of any change in clinical condition. Patients are evaluated with: * The Confusion Assessment Method (CAM) * The 4AT Scale
Incidence of Delirium, its association with risk factors and their prognostic value
Time frame: After surgery and for the next 48 hours
Detection of any change in clinical condition. Patients are evaluated with: * The Confusion Assessment Method (CAM) * The 4AT Scale
5 secondary outcomes
Mortality rates
Time frame: In-Hospital
Mortality rates
Time frame: At 1,3 and 12 months follow-up
Mean Hospital Stay
Time frame: In-Hospital
Clinical Complications
Time frame: In-Hospital
Changes in functional capabilities
Time frame: At 1, 3 and 12 months follow-up
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 29 Dec 2015.
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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.
Marco Mannucci, MD study director
Azienda Ospedaliero-Universitaria Careggi
Alessandro Cartei, MD principal investigator
Azienda Ospedaliero-Universitaria Careggi
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 Delirium and Bone Fractures, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 29 Dec 2015. 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 Italy. 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?
Prevalence of Delirium, its association with risk factors and their prognostic value (time frame: At hospital admission). The study lists 3 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 29 Dec 2015.