- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01701765
Outcomes and Discharge of Long-stay Psychiatric Patients (PERDOVE)
October 6, 2012 updated by: Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)
An increasing number of severely ill patients require long-term care in non-hospital Residential Facilities (RFs).
Despite the magnitude of this development, only a few detailed longitudinal studies on fairly larger samples of residents have provided important information about this population.
The PERDOVE study is the first study carried out in Italy aimed at obtaining comprehensive data about the course and outcome of patients living in RFs, and test whether discharge to independent accommodations is a real option for many patients.
The major aims are three: (1) to describe the sociodemographic, clinical, and treatment-related characteristics of patients treated in RFs during an index period in 2010; (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up; and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each individual patient.
The primary endpoint was discharge within one year as a measure of good outcome.
The PERDOVE study is an observational cohort study, involving 23 RFs all belonging to the St John of God Order, located in Northern Italy.
The first step involves the evaluation of all RFs with a Structure Schedule, which assesses the following areas: logistics structure, general organization: internal rules, meals, clothing and personal hygiene; staff and users' characteristics and meetings, documentation system and evaluation activities; rehabilitative activities provided inside the RF itself.
In the second step a research assistant completed a standardised assessment of each resident with the manager and staff; clinical diagnoses were made by treating clinicians.
A number of standardised instruments were administered.
At one year follow-up, changes in clinical and life conditions of the patients were evaluated and selected rating scales were administered again.
For patients discharged to the community or to other RFs, a research assistant contacted the patient's psychiatrist and asked him/her to fill out the follow-up documentation.
With regard to residents' discharge, investigators hypothesised that the likelihood of community discharge would be associated both with the level of social support outside the facilities, and with the degree of patients' psychological and social impairment.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
403
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brescia, Italy, 20125
- IRCCS Centro san Giovanni di Dio
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Milano
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Cernusco sul Naviglio, Milano, Italy, 20063
- IRCSS Sant'Ambrogio
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San Colombano al Lambro, Milano, Italy, 20078
- IRCCS Sacro Cuore di Gesù
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Torino
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San Maurizio Canavese, Torino, Italy, 10077
- IRCCS Presidio Ospedaliero Beata Verigine della Consolata
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Psychiatric patients staying in residential facilities.
Description
Inclusion Criteria:
- psychiatric diagnosis
- age < 65
- staying in september 2010 in any of 23 RFs located in Northern Italy
Exclusion Criteria:
- elderly patients (over 65 yrs)
- primary diagnosis of organic mental disorder
- refusal of signing an informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients in residential facilities
All patients staying in September 2010 in 23 medium-long term RFs of the St John of God Order in Northern Italy with a primary psychiatric diagnosis and younger than 65 years recruited.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discharge
Time Frame: 1 year
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Percentage of patients discharged home one year after the baseline assessment compared to patients staying in the same residential facility or transferred to other institutions (e.g., other residential facilities, nursing homes, jails, etc)
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scores of standardized rating scales
Time Frame: 1 year
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Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)
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1 year
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Satisfaction assessed with the VSSS
Time Frame: 1 year
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Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lanfredi M, Candini V, Buizza C, Ferrari C, Boero ME, Giobbio GM, Goldschmidt N, Greppo S, Iozzino L, Maggi P, Melegari A, Pasqualetti P, Rossi G, de Girolamo G; PERDOVE group. The effect of service satisfaction and spiritual well-being on the quality of life of patients with schizophrenia. Psychiatry Res. 2014 May 15;216(2):185-91. doi: 10.1016/j.psychres.2014.01.045. Epub 2014 Feb 6.
- de Girolamo G, Candini V, Buizza C, Ferrari C, Boero ME, Giobbio GM, Goldschmidt N, Greppo S, Iozzino L, Maggi P, Melegari A, Pasqualetti P, Rossi G. Is psychiatric residential facility discharge possible and predictable? A multivariate analytical approach applied to a prospective study in Italy. Soc Psychiatry Psychiatr Epidemiol. 2014 Jan;49(1):157-67. doi: 10.1007/s00127-013-0705-z. Epub 2013 May 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
October 3, 2012
First Submitted That Met QC Criteria
October 3, 2012
First Posted (Estimate)
October 5, 2012
Study Record Updates
Last Update Posted (Estimate)
October 10, 2012
Last Update Submitted That Met QC Criteria
October 6, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-2-PEV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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