Functionally-Impaired ElderlyVIP2NCT03138278
Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
A study testing Telephone support on demand in people with Functionally-Impaired Elderly and Caregivers, run by University of Bergen.
Trial summary
It is known from extensive documentation that second victims in critical illness often are the care givers of the patients: family, friends or other persons. Although this has not been specifically studied in the very old patients, there is no reason to believe that this group will be different from other ICU… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Functionally-Impaired Elderly, Caregivers, PTSD
- What is being tested?
- Telephone support on demand
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2024
- Phase
- Interventional
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospital survivors after any ICU admission
Who cannot join
- Imminent terminal care
About this study
It is known from extensive documentation that second victims in critical illness often are the care givers of the patients: family, friends or other persons. Although this has not been specifically studied in the very old patients, there is no reason to believe that this group will be different from other ICU patients. Even more so, in this very old age patient group there are seldom any older relatives. Partners, like wife/husband or other cohabitants, may be dead or themselves incapacitated. Many will be in institutional care. The closest care-givers will be middle-aged people such as children or others, if no partners are available.
The hypothesis is that critical illness can be a large stressor to care-givers of survivors in the VIP measured as the occurrence and severity of the usual problems like PTSD and depression. The investigators hypothesize that a low-threshold on-line support program decreases the magnitude of anxiety, depression and PTSD for care-givers of very old intensive care patients (VIP) after discharge.
Read the detailed description
Aims of the study
- Results from family/care givers experience: Degree of involvement with post-ICU care, impact on their own health (depression, PTSD, burden questionnaire)
- Effect of a simple intervention: on-line support and/or telephone advice on Return to pre-ICU frailty score (patients) and Occurrence of PTSD and depression in care-givers
- Information on 6 months' outcome (frailty and mortality) in very old survivors after ICU in different European countries
- Information on trajectories in the time after discharge: Dead/alive, home, nursing home, new hospital admissions, living with family/other care-givers, etc.
- Conditions
- Functionally-Impaired Elderly, Caregivers, PTSD, Depression, Anxiety, Intensive Care Unit Syndrome
- Being tested
- Telephone support on demand
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone support on demandOther
Dedicated phone number for help and advice for caregivers
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | ICU with ordinary care for elderly ICU survivors and their care-givers |
| Telephone support | Active comparator | ICU with day-time telephone support to care-givers Receives: Other: Telephone support on demand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden scale for Family Caregiver
In order to assess the burden of care the investigaors will use an European questionaire developed within the EU and freely available online: Assessment of subjective burden of informal caregivers (http://www.psychiatrie.uk-erlangen.de/index.php?id=11049/) available in 20 European languages
Measured: 6 months post ICU discharge
Post traumatic stress (PTSD) in caregivers
The study will use PTSD questionnaire PTSS-14 as described at www.sthk.nhs.uk/library/documents/7308450_ptss14.pdf.
Measured: 6 months post ICU discharge
Anxiety and Depression in caregivers
The investigators will use the "Hospital anxiety and depression scale", a questionaire often used out of hospital as well. It is a simple questionaire that will be delivered to the care-givers after 6 months.
Measured: 6 months post ICU discharge
Secondary outcomes (2)
6 months survival in the elderly ICU survivors
Time of death in non-survivors (patients) will be sought through administrative hospital data (when available) or from care-givers
Measured: 6 months post ICU discharge
Trajectories in the elderly ICU survivors
The investigators will seek to describe where the patients have been after hospital discharge: like rehabilitation facilities, nursing home, togehter with care-givers or in their own home.
Measured: 6 months post ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startMay 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: No longer priority in the research group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functionally-Impaired ElderlyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre study with ≥ 100 ICUs from Europe. Randomisation at ICU level to give support to caregivers or not (cluster-randomisation)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Hans Flaatten, University of Bergen
- Investigators
- Hans Flaatten, Prof, Principal investigator, University of bergen; ESICM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138278
- Sponsor's protocol ID
- ESICM VIP2
- Acronym
- VIP2
- Status last verified
- Feb 2024
- First submitted
- 26 Apr 2017
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
- ClinicalTrials.gov ID
- NCT03138278
- Acronym / sponsor ID
- VIP2 / ESICM VIP2
- Conditions
- Functionally-Impaired Elderly, Caregivers, PTSD, Depression, Anxiety, Intensive Care Unit Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer priority in the research group.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- May 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 May 2017 (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.
It is known from extensive documentation that second victims in critical illness often are the care givers of the patients: family, friends or other persons. Although this has not been specifically studied in the very old patients, there is no reason to believe that this group will be different from other ICU patients. Even more so, in this very old age patient group there are seldom any older relatives. Partners, like wife/husband or other cohabitants, may be dead or themselves incapacitated. Many will be in institutional care. The closest care-givers will be middle-aged people such as children or others, if no partners are available.
The hypothesis is that critical illness can be a large stressor to care-givers of survivors in the VIP measured as the occurrence and severity of the usual problems like PTSD and depression. The investigators hypothesize that a low-threshold on-line support program decreases the magnitude of anxiety, depression and PTSD for care-givers of very old intensive care patients (VIP) after discharge.
Detailed description
Aims of the study
- Results from family/care givers experience: Degree of involvement with post-ICU care, impact on their own health (depression, PTSD, burden questionnaire)
- Effect of a simple intervention: on-line support and/or telephone advice on Return to pre-ICU frailty score (patients) and Occurrence of PTSD and depression in care-givers
- Information on 6 months' outcome (frailty and mortality) in very old survivors after ICU in different European countries
- Information on trajectories in the time after discharge: Dead/alive, home, nursing home, new hospital admissions, living with family/other care-givers, etc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre study with ≥ 100 ICUs from Europe. Randomisation at ICU level to give support to caregivers or not (cluster-randomisation)
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –ICU with ordinary care for elderly ICU survivors and their care-givers |
| Telephone support | Active comparator | Other: Telephone support on demandICU with day-time telephone support to care-givers |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Hospital survivors after any ICU admission
Key exclusion criteria (1 listed)
- Imminent terminal care
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 |
|---|---|---|
| Telephone support on demandDedicated phone number for help and advice for caregivers | Other | Telephone support |
Primary outcome
Burden scale for Family Caregiver
Time frame: 6 months post ICU discharge
In order to assess the burden of care the investigaors will use an European questionaire developed within the EU and freely available online: Assessment of subjective burden of informal caregivers (http://www.psychiatrie.uk-erlangen.de/index.php?id=11049/) available in 20 European languages
Post traumatic stress (PTSD) in caregivers
Time frame: 6 months post ICU discharge
The study will use PTSD questionnaire PTSS-14 as described at www.sthk.nhs.uk/library/documents/7308450_ptss14.pdf.
Anxiety and Depression in caregivers
Time frame: 6 months post ICU discharge
The investigators will use the "Hospital anxiety and depression scale", a questionaire often used out of hospital as well. It is a simple questionaire that will be delivered to the care-givers after 6 months.
2 secondary outcomes
6 months survival in the elderly ICU survivors
Time frame: 6 months post ICU discharge
Trajectories in the elderly ICU survivors
Time frame: 6 months post ICU discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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.
Hans Flaatten, Prof principal investigator
University of bergen; ESICM
Questions about this trial
What is this clinical trial studying?
A study testing Telephone support on demand in people with Functionally-Impaired Elderly and Caregivers, run by University of Bergen.
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 1 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: withdrawn, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Burden scale for Family Caregiver (time frame: 6 months post ICU discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024.