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

NCT03138278 | Withdrawn

• 1 other identifier: ESICM VIP2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 6 months survival in the elderly ICU survivors

  6 months post ICU discharge

• Trajectories in the elderly ICU survivors

  6 months post ICU discharge

Study Arms (2)

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

Other: Telephone support on demand

Interventions

Telephone support on demand OTHER

Dedicated phone number for help and advice for caregivers

Telephone support

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hospital survivors after any ICU admission

You may not qualify if:

• Imminent terminal care

Sponsors & Collaborators

• University of Bergen: lead
• European Society of Intensive Care Medicine: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Hans Flaatten, Prof

  University of bergen; ESICM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor emeritus and senior consultant R&D

Model Details: Multicentre study with ≥ 100 ICUs from Europe. Randomisation at ICU level to give support to caregivers or not (cluster-randomisation)

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 3, 2017
• Study Start: May 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share