Brief Summary

The aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

196

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

March 24, 2021

Completed

16 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed

13 days until next milestone

Study Start

First participant enrolled

April 22, 2021

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2024

Completed

Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

3.5 years

First QC Date

March 24, 2021

Last Update Submit

May 27, 2025

Conditions

Caregiver Stress Syndrome

Keywords

CaregiversPost traumatic stressHealth related quality of lifeIntensive care

Outcome Measures

Primary Outcomes (7)

Post traumatic stress
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES\_R). The total score for the IES\_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Group differences at f-up month 3
Post traumatic stress
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES\_R). The total score for the IES\_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Group differences at f-up month 6
Post traumatic stress
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES\_R). The total score for the IES\_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Group differences at f-up month 12
Anxiety and Depression
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Change from baseline to f-up month 3
Anxiety and Depression
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Change from baseline to f-up month 6
Anxiety and Depression
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Change from baseline to f-up month 12
Quality Adjusted Life Years (QUALYs)
Quality Adjusted Life Years (QUALYs), an economic evaluation of the quality and quantity of life lived, will be derived from the RAND-12 (Short form health survey, developed by the non profit RAND corporation). QUALY scores range from 1 (perfect health) to 0 (death).
Group differences at f-up month 12

Secondary Outcomes (12)

Health related quality of life
Change from baseline to f-up month 3
Health related quality of life
Change from baseline to f-up month 6
Health related quality of life
Change from baseline to f-up month 12
Hope
Change from baseline to f-up month 3
Hope
Change from baseline to f-up month 6
+7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Structured follow up at the ICU * 1-3 days after admittance: Map caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues. * Every 1-2 weeks: Repeat assessment of symptoms and needs with the assessment tool followed by a meeting with a nurse. * At discharge: Structured conversation focusing on information and preparation for the transition to a regular ward or to another hospital including a card with information and support. * Bereavement: Individualized support based on caregiver expressed needs, preferences and previous mapping, including a card with information and support. * Follow up: Caregivers or bereaved will be contacted after 4-6 weeks, and will be offered a follow up conversation either on phone or at the unit.

Behavioral: Structured support of caregivers at the ICU

Follow up as usual (Control)

NO INTERVENTION

Follow up as usual at the ICU

Interventions

Structured support of caregivers at the ICUBEHAVIORAL

Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses

Intervention

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Caregivers of patients admitted to the intensive care unit that is expected to receive invasive mechanical ventilation for at least 48 hours
Between 18 and 70 years old
Able to understand and speak Norwegian

You may not qualify if:

None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Oslo University Hospitallead
The Dam Foundationcollaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (2)

Watland S, Solberg Nes L, Hanson E, Ekstedt M, Stenberg U, Borosund E. The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study. JMIR Form Res. 2023 Apr 25;7:e46299. doi: 10.2196/46299.
PMID: 37097744BACKGROUND
Watland S, Solberg Nes L, Ekeberg O, Rostrup M, Hanson E, Ekstedt M, Stenberg U, Hagen M, Borosund E. The Caregiver Pathway Intervention Can Contribute to Reduced Post-Intensive Care Syndrome Among Family Caregivers of ICU Survivors: A Randomized Controlled Trial. Crit Care Med. 2025 Mar 1;53(3):e555-e566. doi: 10.1097/CCM.0000000000006546. Epub 2024 Dec 24.
PMID: 39718436RESULT

Study Officials

Elin Børøsund, PhD
Oslo University Hospital
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: Senior researcher

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 9, 2021

Study Start

April 22, 2021

Primary Completion

October 21, 2024

Study Completion

October 21, 2024

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing: Will not share

Locations

NO(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (12)

Study Arms (2)

Intervention

Follow up as usual (Control)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations