Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.

Conditions
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Caregivers, PTSD, Depression, Anxiety, Intensive Care Unit Syndrome, Functionally-Impaired Elderly

Intervention / Treatment
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* Other: Telephone support on demand


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospital survivors after any ICU admission Exclusion Criteria: Imminent terminal care

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>ICU with ordinary care for elderly ICU survivors and their care-givers | |
| Active Comparator: Telephone support<br>ICU with day-time telephone support to care-givers | Other: Telephone support on demand<br>* Dedicated phone number for help and advice for caregivers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 6 months post ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 6 months post ICU discharge |