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

6. oktober 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

403

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Brescia, Italien, 20125
        • IRCCS Centro San Giovanni di Dio
    • Milano
      • Cernusco sul Naviglio, Milano, Italien, 20063
        • IRCSS Sant'Ambrogio
      • San Colombano al Lambro, Milano, Italien, 20078
        • IRCCS Sacro Cuore di Gesù
    • Torino
      • San Maurizio Canavese, Torino, Italien, 10077
        • IRCCS Presidio Ospedaliero Beata Verigine della Consolata

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Psychiatric patients staying in residential facilities.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Discharge
Tidsramme: 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)
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Scores of standardized rating scales
Tidsramme: 1 year
Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)
1 year
Satisfaction assessed with the VSSS
Tidsramme: 1 year
Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2010

Primær færdiggørelse (Faktiske)

1. januar 2011

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

3. oktober 2012

Først indsendt, der opfyldte QC-kriterier

3. oktober 2012

Først opslået (Skøn)

5. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2012-2-PEV

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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