Clinical trial NCT03138278: Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
Official title: Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Functionally-Impaired Elderly
Caregivers
PTSD
Depression, Anxiety
Intensive Care Unit Syndrome
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2017-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre study with ≥ 100 ICUs from Europe. Randomisation at ICU level to give support to caregivers or not (cluster-randomisation)
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Hospital survivors after any ICU admission

Exclusion Criteria:

* Imminent terminal care

Primary outcomes:
measure: Burden scale for Family Caregiver
timeFrame: 6 months post ICU discharge
measure: Post traumatic stress (PTSD) in caregivers
timeFrame: 6 months post ICU discharge
measure: Anxiety and Depression in caregivers
timeFrame: 6 months post ICU discharge
Secondary outcomes:
measure: 6 months survival in the elderly ICU survivors
timeFrame: 6 months post ICU discharge
measure: Trajectories in the elderly ICU survivors
timeFrame: 6 months post ICU discharge
Other outcomes:
Locations:
Study officials:
affiliation: University of bergen; ESICM
name: Hans Flaatten, Prof
role: PRINCIPAL_INVESTIGATOR
References: