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the Role of Technology in Elderly Patients (SILVER)

2021年9月1日 更新者:Patrizia D'Amelio、Centre Hospitalier Universitaire Vaudois

Fighting Against Social Isolation in Times of Pandemic Corona Virus-19: the Role of Technology in Elderly Patients: The SILVER Study

Starting from December 2019, the Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-COV-2) disease spread rapidly from China into the world, with about two Mio cases confirmed around the world. In Switzerland, more than 26'000 cases have been confirmed so far, and health authorities declared in March the needs for social isolation and have banned visits to hospitalized patients and to nursing home residents. Loneliness and isolation is a significant concern for the elderly patients as well as for their families that may significantly affect physical and mental health in both.

SILVER aims to evaluate the role of programmed video calls with families:

  • on mood, anxiety, fear of death and pain perception in patients hospitalized or in nursing homes during the SARS-COV-2 pandemic.
  • in relieving the familiar caregiver anxiety and fear of death of others
  • in relieving the professional caregiver anxiety.

SILVER is an international study involving both acute, rehabilitation geriatric units and nursing homes; we will enroll all the patients present in the participating centers. Patients will be allowed to chose between video and phone calls, the following dimensions will be evaluated:

  • Delirium risk: using the Confusion Assessment Method (CAM)
  • Mood: using the 5-item Geriatric Depression Scale (GDS)
  • Anxiety: using the Clinical Anxiety Scale (GAS).
  • Fear of death (self and others): using the Collett-Lester scale. In parallel, health professionals and family caregivers will be evaluated for anxiety at baseline and every week after intervention set-up by the Clinical Anxiety Scale (CAS). Family caregivers will also be evaluated with the fear of death scale (sub-scale fear of death of others).

Finally, to evaluate the appreciation for video call communication in patients and caregivers we will use a Likert scale.

研究概览

地位

完全的

详细说明

Aims.

  • To evaluate the role of video calls with families on mood, anxiety, fear of death and pain perception in patients hospitalized or in nursing homes during the SARS-CoV-2 pandemic.
  • To evaluate the role of video calls in relieving family caregivers' anxiety and fear of death of their loved one.
  • To evaluate the role of video calls in relieving health professionals' anxiety.

Methods. In order to reduce social isolation from their relatives and friends patients will be helped in joining them through video-calls thanks to the use of dedicated tablets and to the assistance provided by nurses, assistant-nurses, occupational therapists or neuropsychologists.

Population selection. All the patients in the participating centers fulfilling inclusion/exclusion criteria will be enrolled in SILVER.

Patients will be asked to chose between video and phone call, phone call will be allowed without any restriction to both video and usual care groups.

standardization of video calls: Two video-calls of maximum 15' will be administered every week; in addition, patients will be allowed to do video-call upon request. Video-calls will be performed using Skype or WhatsApp video or Face-time, the use of others app will be evaluated upon family's request.

Data collection for primary and secondary outcomes. Patients will be evaluated at baseline and every week with standardized scales to assess their mood, anxiety and delirium symptoms.

At baseline and at the end of the intervention we will evaluate the overall appreciation of the video call by the patients, their family caregiver, and the health professionals using a Likert scale and Anxiety: using the Geriatric Anxiety Scale (GAS).

In order to clarify the role of social connection through video calls on the patients' health, we will evaluate at baseline and after one week :

  • Mood: using the 5-items Geriatric Depression Scale (GDS-5)
  • Fear of death (self and others): using the Collett-Lester scale
  • Delirium risk: using the Confusion Assessment Method (CAM) will be evaluated every day and will be analyzed ad day of delirium weekly.

In addition, the effect of video calls in professionals and in family caregivers will be evaluated as follows:

family and professional caregivers will be evaluated for anxiety at baseline and the end of intervention set-up by the Clinical anxiety (CAS). Familiar care-givers will also be evaluated with the fear of death scale (sub-scale fear of death of others) at the baseline and after one week.

Collection of other data.

In order to correct the statistical analyses for possible confounding variables the following data will be collected:

Age, gender, years of school, duration of hospitalization , type of hospital discharge, Mini Mental State Examination (MMSE), Clinical Dementia Rating (CDR) scale, Cumulative Illness Rating Scale (CIRS) index, Activity of Daily Living (ADL), Instrumental Activities of Daily Living (IADL).

研究类型

观察性的

注册 (实际的)

64

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lausanne、瑞士、1012
        • Patrizia D'amelio

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

SILVER is an observational multicentre study. Patients hospitalized in two geriatric Unit in Switzerland (the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne and the Hôpitaux Universitaire Genève (HUG) in Geneva,) and in one geriatric unit in Italy (Santa Misericordia Hospital in Perugia) and their families

描述

Inclusion Criteria:

  • patients of 65 years and older hospitalized in the participating unit during the absence of visits due to the SARS-CoV2 pandemic.
  • Patients and families willing to participate.

Exclusion Criteria:

  • patients or families who refuse to participate.
  • Clinical Dementia Rating (CDR) equal or higher than two.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
phone calls
patients choosing phone calls as preferred communication technique
A tablet for video-calls will be available for patients and families. Two video-calls of maximum 15' will be organized every week; in addition, patients will be allowed to do video-call upon request. Video-calls will be performed using Skype or WhatsApp video or Face-time
其他名称:
  • 电话
video call
patients choosing video calls as preferred communication technique
A tablet for video-calls will be available for patients and families. Two video-calls of maximum 15' will be organized every week; in addition, patients will be allowed to do video-call upon request. Video-calls will be performed using Skype or WhatsApp video or Face-time
其他名称:
  • 电话

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
4-point likert scale (LKRT)
大体时间:0-7 days
appreciation of video calls by patients and families rage 0-4, 4 represent the better outcome
0-7 days
Geriatric anxiety scale (GAS-10)
大体时间:0-7 days
measure of anxiety, The GAS-10 form, contains a total of 10 items, the answers are yes or no and the possible scores range from 0 to 10, with a cut-off point for anxiety at 6. The higher the score, the greater the anxiety.
0-7 days
Collett Lester Fear of Death scale (CL-FOD) for self and others
大体时间:0-7 days
fear of death scale of patients, The CL-FODS contains 28 items, with seven items on each of the four subscales: Fear of Death of Self, Dying of Self, Death of Others, and Dying of Others. It is answered on a 5-point Likert format anchored as follows: 1 (not) and 5 (very). The total score in each subscale could range from 7 to 35, with higher scores denoting higher anxiety from death or dying.
0-7 days
geriatric depression scale (GDS-5)
大体时间:0-7 days
mood evaluation for patients. the GDS-5 contains 5 items, the total score range from 0 to 5, the clinical cut-off for suspicion of depression is 2
0-7 days

次要结果测量

结果测量
措施说明
大体时间
Collett Lester Fear of Death scale (CL-FOD) for others
大体时间:0-7 days
fear of death scale of others for family
0-7 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月2日

初级完成 (实际的)

2021年3月4日

研究完成 (实际的)

2021年7月31日

研究注册日期

首次提交

2021年8月3日

首先提交符合 QC 标准的

2021年8月10日

首次发布 (实际的)

2021年8月11日

研究记录更新

最后更新发布 (实际的)

2021年9月9日

上次提交的符合 QC 标准的更新

2021年9月1日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2020-01125

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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