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临床试验/NCT04408196
NCT04408196已完成不适用

Effects of Social Distancing on the Quality of Life and on the Emotional-affective Sphere of Caregivers and Patients Hospitalized in Residential Rehabilitation Departments: an Observational Study.

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2020年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
1
主要终点
Short Form-36 Health Survey (SF36)

研究概览

简要总结

Coronavirus disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) virus. This virus was identified in December 2019 in the Chinese city of Wuhan, in the province of Hubei, where it determined a state of health emergency proclaimed by China on January 30, 2020.

Since February 2020, Italy has been involved in the emergency of the COVID-19 infection, with devastating consequences for the health of the population and the economy of our country. As published by the Italian National Institute of Health, the starting date of the symptoms dates back to the end of January, the first case diagnosed dates back to 21 February 2020 while the first cases of home isolation date back to March 1st, 2020. On March 30, 2020, there were 101739 positive subjects and 11591 deaths (Civil Protection data).

According to data published by the World Health Organization, most people with COVID-19 develop a flu-like form, 14% develop a severe form that requires hospitalization and oxygen therapy and 5% require an ICU admission.

The emergency from Covid19 made it necessary to provide institutional social distancing conditions which resulted in rehabilitation departments being prohibited from visiting patients by family members and/or caregivers. This event, although necessary, led to the first moment of discomfort on the part of patients and family members; to overcome this reaction "technological" solutions were found, trying to give continuity to the contact between the patient and the family member through the use of video calls. Despite this, the COVID-19 emergency and the limitations resulting from social distancing likely have an impact on both patients and family members/caregivers that needs to be assessed.

详细描述

Aims:

The study aims to measure the quality of life (QoL) and the emotional-affective sphere of patients, currently hospitalized in residential structures, and their family members.

The study data will allow identifying (a) whether the social distancing between family members/caregivers and patients undergoing rehabilitation for orthopedic or neurological disabilities affects the quality of life and the emotional-affective sphere and (b) if these conditions change over time. The data obtained will, therefore, allow identifying those subjects who present a particular fragility of the emotional-affective sphere and who therefore need attention and possibly psychological support that will be prescribed.

Procedures:

Demographic (for patients and caregivers) and anamnestic (only for patients) data will be collected; moreover, disability will be assessed in patients using the modified Barthel index.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients admitted to the centers of the Don Gnocchi Foundation participating in the study and their caregivers will be recruited

排除标准

  • For patients: a score on the Mini-Mental State Examination (MMSE) scale lower than 24 which prevents the administration of SF36;
  • For patients and caregivers: failure to acquire informed consent

结局指标

主要结局

Short Form-36 Health Survey (SF36)

时间窗: After one month of hospitalisation (baseline, T0)

It is a questionnaire to evaluate the Quality of Life

Beck Anxiety Inventory (BAI)

时间窗: Two months after baseline (T2)

It is a brief, criteria-referenced assessment for measuring anxiety severity and level

Short Form (36) Health Survey (SF36)

时间窗: Two months after baseline (T2)

It is a questionnaire to evaluate the Quality of Life

Beck Depression Inventory-II (BDI-II)

时间窗: Two months after baseline (T2)

It is a brief, criteria-referenced assessment for measuring depression severity

次要结局

  • modified Barthel Index (mBI)(After one month of hospitalisation (baseline, T0))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Giovanna Aprile

Md, PhD, Principal Investigator, Head of Rehabilitation Unit

Fondazione Don Carlo Gnocchi Onlus

研究点 (1)

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