CoronavirusTOVID-49NCT04333849
Telephony Or Videophony for Isolated elDerly in Maine-Et-Loire 49 During COVID-19
An observational study of Coronavirus, run by University Hospital, Angers at 1 site in France.
Trial summary
The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Coronavirus
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2020to 11 May 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients are recruited during their hospitalisation in acute care geriatric unit or institutionalization in St Nicolas during the isolation measures linked to the SARS-CoV-2 epidemic.
Who may be able to join
- Hospitalisation in the acute care geriatric unit (Angers UH) or institutionalization in St Nicolas during the isolation measures linked to the SARS-CoV-2 epidemic.
Who cannot join
- Refusal to participate.
- Contraindication posed by the medical team to proposing dematerialized communication.
Trial locations and contacts
1 site in 1 country.
About this study
The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for these fragile populations. The only source of residual social ties during a period of confinement remains dematerialised communication via the various existing communication channels (in particular telephone calls or video telephony).
As soon as the COVID-19 crisis began and the first visiting restrictions were imposed on patients in the geriatric department of the Angers Univesity Hospital and the Retirement Home / long-term care unit, acute care geriatric unit of Angers offered patients and residents the opportunity to organize communication with their relatives via videophone calls. Initial feedback from the field shows us that, contrary to our intuition, patients and residents are not necessarily asking for communication to the outside world and, when they are, the preferred channel is not necessarily video telephony but often a simple phone call with relatives. Even though the vast majority of projects aimed at setting up communication aids for the elderly now rely on videophonic support, these initial observations in everyday care situations raise questions about the directions taken in this area. Also, the investigators ask themselves the following question: in the absence of a physical meeting, what is the preferred means of communication for elderly people in isolation in hospital or in Retirement Home? This study will make it possible to propose the most appropriate solutions for breaking isolation for the hospitalized or institutionalized geriatric population in order to limit as much as possible the increase in social isolation imposed by restrictions on movement during epidemics.
- Conditions
- Coronavirus
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred means of communication for elderly people in isolation, hospitalized in the acute care geriatric unit or residing at St Nicolas nursing home (Angers UH).
Choice between videophony, telephony or neither.
Measured: at baseline (day 0)
Secondary outcomes (5)
proportion of elderly people with loss of functional independence to communicate with their relatives.
Aid received or not (by a caregiver) in connecting with the relative.
Measured: at baseline (day 0)
level of satisfaction of patients who have benefited from a telephone call.
The satisfaction will be assessed using a non-validated satisfaction questionnaire based on a forced choice Likert scale in 6 points from 1 to 6. Patients will be considered as satisfied if the mean score is over 4 on 6.
Measured: at baseline (day 0)
level of satisfaction of patients who have benefited from a videophone call.
The satisfaction will be assessed using a non-validated satisfaction questionnaire based on a forced choice Likert scale in 6 points from 1 to 6. Patients will be considered as satisfied if the mean score is over 4 on 6.
Measured: at baseline (day 0)
satisfaction level of older people according to the means of communication used.
The satisfaction averages of the two groups wishing to use a means of communication (telephony or videophony) will be compared by a Student t-test.
Measured: at baseline (day 0)
impact of age on the preferred means of communication.
Measured: at baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start25 Mar 2020
- Primary completion11 May 2020
- Study completion11 May 2020
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 CoronavirusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333849
- Sponsor's protocol ID
- 2020/29
- Acronym
- TOVID-49
- Status last verified
- Mar 2020
- First submitted
- 1 Apr 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sacco G, Lleonart S, Simon R, Noublanche F, Annweiler C; TOVID Study Group. Communication Technology Preferences of Hospitalized and Institutionalized Frail Older Adults During COVID-19 Confinement: Cross-Sectional Survey Study. JMIR Mhealth Uhealth. 2020 Sep 18;8(9):e21845. doi: 10.2196/21845.
PubMed 32896832
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephony Or Videophony for Isolated elDerly in Maine-Et-Loire 49 During COVID-19
- ClinicalTrials.gov ID
- NCT04333849
- Acronym / sponsor ID
- TOVID-49 / 2020/29
- Conditions
- Coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 3 Apr 2020 (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.
The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for these fragile populations. The only source of residual social ties during a period of confinement remains dematerialised communication via the various existing communication channels (in particular telephone calls or video telephony).
As soon as the COVID-19 crisis began and the first visiting restrictions were imposed on patients in the geriatric department of the Angers Univesity Hospital and the Retirement Home / long-term care unit, acute care geriatric unit of Angers offered patients and residents the opportunity to organize communication with their relatives via videophone calls. Initial feedback from the field shows us that, contrary to our intuition, patients and residents are not necessarily asking for communication to the outside world and, when they are, the preferred channel is not necessarily video telephony but often a simple phone call with relatives. Even though the vast majority of projects aimed at setting up communication aids for the elderly now rely on videophonic support, these initial observations in everyday care situations raise questions about the directions taken in this area. Also, the investigators ask themselves the following question: in the absence of a physical meeting, what is the preferred means of communication for elderly people in isolation in hospital or in Retirement Home? This study will make it possible to propose the most appropriate solutions for breaking isolation for the hospitalized or institutionalized geriatric population in order to limit as much as possible the increase in social isolation imposed by restrictions on movement during epidemics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients are recruited during their hospitalisation in acute care geriatric unit or institutionalization in St Nicolas during the isolation measures linked to the SARS-CoV-2 epidemic.
Key inclusion criteria (1 listed)
- Hospitalisation in the acute care geriatric unit (Angers UH) or institutionalization in St Nicolas during the isolation measures linked to the SARS-CoV-2 epidemic.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Contraindication posed by the medical team to proposing dematerialized communication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preferred means of communication for elderly people in isolation, hospitalized in the acute care geriatric unit or residing at St Nicolas nursing home (Angers UH).
Time frame: at baseline (day 0)
Choice between videophony, telephony or neither.
5 secondary outcomes
proportion of elderly people with loss of functional independence to communicate with their relatives.
Time frame: at baseline (day 0)
level of satisfaction of patients who have benefited from a telephone call.
Time frame: at baseline (day 0)
level of satisfaction of patients who have benefited from a videophone call.
Time frame: at baseline (day 0)
satisfaction level of older people according to the means of communication used.
Time frame: at baseline (day 0)
impact of age on the preferred means of communication.
Time frame: at baseline (day 0)
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 20 Jul 2020.
- Derived from this study: PubMed 32896832Sacco G, Lleonart S, Simon R, Noublanche F, Annweiler C; TOVID Study Group. Communication Technology Preferences of Hospitalized and Institutionalized Frail Older Adults During COVID-19 Confinement: Cross-Sectional Survey Study. JMIR Mhealth Uhealth. 2020 Sep 18;8(9):e21845. doi: 10.2196/21845.
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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 Coronavirus, run by University Hospital, Angers at 1 site in France.
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 1 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 20 Jul 2020. 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 France. 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?
Preferred means of communication for elderly people in isolation, hospitalized in the acute care geriatric unit or residing at St Nicolas nursing home (Angers UH). (time frame: at baseline (day 0)). 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 NCT04333849, 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 20 Jul 2020.