Fighting Against Social Isolation in Times of Pandemic Corona Virus-19: the Role of Technology in Elderly Patients: The SILVER Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Geriatric anxiety scale (GAS-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •patients or families who refuse to participate.
- •Clinical Dementia Rating (CDR) equal or higher than two.
结局指标
主要结局
Geriatric anxiety scale (GAS-10)
时间窗: 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.
Collett Lester Fear of Death scale (CL-FOD) for self and others
时间窗: 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.
geriatric depression scale (GDS-5)
时间窗: 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
4-point likert scale (LKRT)
时间窗: 0-7 days
appreciation of video calls by patients and families rage 0-4, 4 represent the better outcome
次要结局
- Collett Lester Fear of Death scale (CL-FOD) for others(0-7 days)
研究者
Patrizia D'Amelio
associated professor
Centre Hospitalier Universitaire Vaudois