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

PTSD Clinical Trial

— VIP2  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03138278
• Other study ID #: ESICM VIP2
• Status: Withdrawn
• Phase: N/A
• Start date: May 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Hospital survivors after any ICU admission

Exclusion Criteria:

• Imminent terminal care

Related Conditions & MeSH terms

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

Intervention

Other:
• Telephone support on demand
Dedicated phone number for help and advice for caregivers

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	European Society of Intensive Care Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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