AnxietySILVERNCT05000099
the Role of Technology in Elderly Patients
An observational study of Anxiety and Depression, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxiety, Depression, Aging
- What is being tested?
- video calls
- Type of treatment
- Pill or oral medicine
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Dec 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
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
Who may be able to join
- 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.
Who cannot join
- patients or families who refuse to participate.
- Clinical Dementia Rating (CDR) equal or higher than two.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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).
- Conditions
- Anxiety, Depression, Aging, Social Isolation
- Being tested
- video calls
- Medical subject headings
- Anxiety Disorders, Depression, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video callsOther
Also called phone calls
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
| Study group | Role | What they receive |
|---|---|---|
| phone calls | patients choosing phone calls as preferred communication technique Receives: Other: video calls | |
| video call | patients choosing video calls as preferred communication technique Receives: Other: video calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-point likert scale (LKRT)
appreciation of video calls by patients and families rage 0-4, 4 represent the better outcome
Measured: 0-7 days
Geriatric anxiety scale (GAS-10)
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.
Measured: 0-7 days
Collett Lester Fear of Death scale (CL-FOD) for self and others
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.
Measured: 0-7 days
geriatric depression scale (GDS-5)
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
Measured: 0-7 days
Secondary outcomes (1)
Collett Lester Fear of Death scale (CL-FOD) for others
fear of death scale of others for family
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start2 Dec 2020
- Primary completion4 Mar 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrizia D'Amelio, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000099
- Sponsor's protocol ID
- 2020-01125
- Acronym
- SILVER
- Status last verified
- Sep 2021
- First submitted
- 3 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35794314
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fighting Against Social Isolation in Times of Pandemic Corona Virus-19: the Role of Technology in Elderly Patients: The SILVER Study
- ClinicalTrials.gov ID
- NCT05000099
- Acronym / sponsor ID
- SILVER / 2020-01125
- Conditions
- Anxiety, Depression, Aging, Social Isolation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phone calls | – | Other: video callspatients choosing phone calls as preferred communication technique |
| video call | – | Other: video callspatients choosing video calls as preferred communication technique |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- patients or families who refuse to participate.
- Clinical Dementia Rating (CDR) equal or higher than two.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video callsAlso: phone callsA 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 | Other | phone calls, video call |
Primary outcome
4-point likert scale (LKRT)
Time frame: 0-7 days
appreciation of video calls by patients and families rage 0-4, 4 represent the better outcome
Geriatric anxiety scale (GAS-10)
Time frame: 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
Time frame: 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)
Time frame: 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
1 secondary outcome
Collett Lester Fear of Death scale (CL-FOD) for others
Time frame: 0-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 35794314Durst 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-point likert scale (LKRT) (time frame: 0-7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.