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

NCT ID: NCT03138278

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual care

ICU with ordinary care for elderly ICU survivors and their care-givers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Telephone support

ICU with day-time telephone support to care-givers

Group Type: ACTIVE_COMPARATOR

Telephone support on demand

Intervention Type: OTHER

Dedicated phone number for help and advice for caregivers

Interventions

Telephone support on demand

Dedicated phone number for help and advice for caregivers

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Hospital survivors after any ICU admission

Exclusion Criteria

• Imminent terminal care

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society of Intensive Care Medicine

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Hans Flaatten

Professor emeritus and senior consultant R&D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans Flaatten, Prof

Role: PRINCIPAL_INVESTIGATOR

University of bergen; ESICM

Other Identifiers

ESICM VIP2

Identifier Type: -

Identifier Source: org_study_id