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临床试验/NCT01701765
NCT01701765已完成不适用

Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)

IRCCS Centro San Giovanni di Dio Fatebenefratelli4 个研究点 分布在 1 个国家目标入组 403 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
403
试验地点
4
主要终点
Discharge

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • psychiatric diagnosis
  • age < 65
  • staying in september 2010 in any of 23 RFs located in Northern Italy

排除标准

  • elderly patients (over 65 yrs)
  • primary diagnosis of organic mental disorder
  • refusal of signing an informed consent

结局指标

主要结局

Discharge

时间窗: 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)

次要结局

  • Scores of standardized rating scales(1 year)
  • Satisfaction assessed with the VSSS(1 year)

研究者

发起方
IRCCS Centro San Giovanni di Dio Fatebenefratelli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni de Girolamo, M.D.

M.D.

IRCCS Centro San Giovanni di Dio Fatebenefratelli

研究点 (4)

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