Clinical trial NCT05000099: the Role of Technology in Elderly Patients
Official title: Fighting Against Social Isolation in Times of Pandemic Corona Virus-19: the Role of Technology in Elderly Patients: The SILVER Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Depression
Aging
Social Isolation
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: 4-point likert scale (LKRT)
timeFrame: 0-7 days
measure: Geriatric anxiety scale (GAS-10)
timeFrame: 0-7 days
measure: Collett Lester Fear of Death scale (CL-FOD) for self and others
timeFrame: 0-7 days
measure: geriatric depression scale (GDS-5)
timeFrame: 0-7 days
Secondary outcomes:
measure: Collett Lester Fear of Death scale (CL-FOD) for others
timeFrame: 0-7 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Patrizia D'amelio
Study officials:
References:
citation: Durst AV, Graf CE, Ruggiero C, Zekry D, Boccardi V, Monney L, Joss I, Vuilloud K, Vespignani G, Bosshard W, Mecocci P, Bula CJ, D'Amelio P. Fighting social isolation in times of pandemic COVID-19: the role of video calls for older hospitalized patients. Aging Clin Exp Res. 2022 Sep;34(9):2245-2253. doi: 10.1007/s40520-022-02188-8. Epub 2022 Jul 6.