DementiaNCT01699984
PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients
An observational study of Dementia and Motor Impairments, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites in Italy.
Trial summary
This prospective observational cohort study aims at studying functional and clinical outcomes of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order in Northern Italy during an index period of 4 months. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Motor Impairments, Stroke
- How many people
- 329 participants
- Where
- 4 sitesItaly
- Study dates
- Feb 2011to Sep 2012
- 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 aged 65 or older admitted to 4 geriatric inpatient facilities.
Who may be able to join
- age 65 or older
- informed consent provided
Who cannot join
- younger than 65 years
- informed consent not provided
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Brescia, 25125
Sacro Cuore di Gesù Centre
San Colombano al Lambro, Milan, 20078
beata Vergine della Consolata Hospital
San Maurizio Canavese, Turin, 10077
San Raffaele Arcangelo Hospital
Venezia, Venezia, 30121
About this study
Official title: THE HOSPITALIZATION OF OLDER PATIENTS: RISK FACTORS, ADVERSE EVENTS AND OUTCOMES. A MULTICENTRE STUDY.
This prospective observational cohort study aims at studying functional and clinical outcomes of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order in Northern Italy during an index period of 4 months. Other areas assessed include variables that help or hinder the discharge of patients with sufficient residential autonomy and the predictive ability of clinicians compared with the evaluation of selective indicators of outcome (clinical and instrumental).
Patients are followed from the first day of hospitalization until discharge or up to 3 months and 1 day after the date of admission ("long-term care" patients).
Read more
At admission a "Patient Form" including social, demographic and clinical informations and a series of standardized assessment tools is completed with the help of clinicians, nurses and caregivers (when available).
For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is performed and adverse events occurred during hospitalization are monitored, as well as the predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at discharge (or after 3 months for "long-term care" patients) and at 6 months follow-up of with a standardized telephone interview to assess clinical and functional status and possible changes in the residential status of the patient.
- Conditions
- Dementia, Motor Impairments, Stroke, Thighbone Fractures
- Keywords
- Cognitive impairment., Geriatrics., Hospital admission., Hospital discharge.
- Medical subject headings
- Dementia, Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients | All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of clinical improvement
Measured: from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up
Secondary outcomes (1)
identification of variables predictive of outcomes
Measured: at discharge (or 3 months after admission) and 6 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 posted4 Oct 2012 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Giovanni de Girolamo, M.D., Principal investigator, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699984
- Sponsor's protocol ID
- 2012-1-PEV
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE HOSPITALIZATION OF OLDER PATIENTS: RISK FACTORS, ADVERSE EVENTS AND OUTCOMES. A MULTICENTRE STUDY.
- ClinicalTrials.gov ID
- NCT01699984
- Acronym / sponsor ID
- 2012-1-PEV
- Conditions
- Dementia, Motor Impairments, Stroke, Thighbone Fractures
- Keywords
- Cognitive impairment., Geriatrics., Hospital admission., Hospital discharge.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Oct 2012 (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.
This prospective observational cohort study aims at studying functional and clinical outcomes of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order in Northern Italy during an index period of 4 months. Other areas assessed include variables that help or hinder the discharge of patients with sufficient residential autonomy and the predictive ability of clinicians compared with the evaluation of selective indicators of outcome (clinical and instrumental).
Patients are followed from the first day of hospitalization until discharge or up to 3 months and 1 day after the date of admission ("long-term care" patients).
At admission a "Patient Form" including social, demographic and clinical informations and a series of standardized assessment tools is completed with the help of clinicians, nurses and caregivers (when available).
For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is performed and adverse events occurred during hospitalization are monitored, as well as the predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at discharge (or after 3 months for "long-term care" patients) and at 6 months follow-up of with a standardized telephone interview to assess clinical and functional status and possible changes in the residential status of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients | – | –All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 or older admitted to 4 geriatric inpatient facilities.
Key inclusion criteria (2 listed)
- age 65 or older
- informed consent provided
Key exclusion criteria (2 listed)
- younger than 65 years
- informed consent not provided
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
evaluation of clinical improvement
Time frame: from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up
1 secondary outcome
identification of variables predictive of outcomes
Time frame: at discharge (or 3 months after admission) and 6 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 4 Oct 2012.
- Website of the coordinating centreLink provided by the sponsor.
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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.
Giovanni de Girolamo, M.D. principal investigator
IRCCS Centro San Giovanni di Dio Fatebenefratelli
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Motor Impairments, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites 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 2 inclusion and 2 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 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
evaluation of clinical improvement (time frame: from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up). 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 4 Oct 2012.