Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05000099
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2021-08-03
Brief Title:
the Role of Technology in Elderly Patients
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Fighting Against Social Isolation in Times of Pandemic Corona Virus-19 the Role of Technology in Elderly Patients The SILVER Study
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SILVER
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 26000 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
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 inclusionexclusion 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 familys 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
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 inclusionexclusion 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 familys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None