COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Outcomes and Discharge of Long-stay Psychiatric Patients (PERDOVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01701765
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brief Summary:
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.

Condition or disease
Mental Disorders

Layout table for study information
Study Type : Observational
Actual Enrollment : 403 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)
Study Start Date : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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.

Primary Outcome Measures :
  1. Discharge [ Time Frame: 1 year ]
    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)

Secondary Outcome Measures :
  1. Scores of standardized rating scales [ Time Frame: 1 year ]
    Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)

  2. Satisfaction assessed with the VSSS [ Time Frame: 1 year ]
    Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Psychiatric patients staying in residential facilities.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01701765

Layout table for location information
IRCSS Sant'Ambrogio
Cernusco sul Naviglio, Milano, Italy, 20063
IRCCS Sacro Cuore di Gesù
San Colombano al Lambro, Milano, Italy, 20078
IRCCS Presidio Ospedaliero Beata Verigine della Consolata
San Maurizio Canavese, Torino, Italy, 10077
IRCCS Centro san Giovanni di Dio
Brescia, Italy, 20125
Sponsors and Collaborators
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Layout table for investigator information
Principal Investigator: Giovanni de Girolamo, M.D. IRCCS Centro San Giovanni di Dio Fatebenefratelli
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Giovanni de Girolamo, M.D., M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli Identifier: NCT01701765    
Other Study ID Numbers: 2012-2-PEV
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli:
Severe mental disorders
Outcome evaluation
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders