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Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old. (VIP2)

U

University of Bergen

Status

Withdrawn

Conditions

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

Treatments

Other: Telephone support on demand

Study type

Interventional

Funder types

Other

Identifiers

NCT03138278
ESICM VIP2

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

80+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hospital survivors after any ICU admission

Exclusion criteria

  • Imminent terminal care

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Usual care
No Intervention group
Description:
ICU with ordinary care for elderly ICU survivors and their care-givers
Telephone support
Active Comparator group
Description:
ICU with day-time telephone support to care-givers
Treatment:
Other: Telephone support on demand

Trial contacts and locations

0

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Central trial contact

Hans Flaatten, Prof

Data sourced from clinicaltrials.gov

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