Clinical Trials Directory

Trials / Completed

CompletedNCT04839406

The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
196 (actual)
Sponsor
Oslo University Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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.

Detailed description

Caregivers of patients admitted to an intensive care unit (ICU) often experience the situation as traumatic and stressful. Long term consequences such as fatigue, anxiety, depression and symptoms of post-traumatic stress are reported among 30-50 percent of the caregivers of critically ill patients. The need for supportive interventions is called for. The overall goal of this project is to improve the support for caregivers of intensive care patients. A systematic intervention for individual support of caregivers, The Caregiver Pathway Intervention, has been developed with a multidisciplinary approach, based on existing evidence, through interviews with former caregivers, workshops with health care personnel and user input and testing. The intervention consist of mapping of caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues, a structured conversation at discharge, and an invitation to a follow-up conversation 4-6 weeks after discharge/patients death. The aim of the project is to test the efficacy of The Caregiver Pathway Intervention among caregivers at the ICU in a randomized controlled trial, using outcome measures such as symptoms of post-traumatic stress, anxiety/depression, cost-utility measures and health-related quality of life. The participants will be randomly assigned to The Caregiver Pathway Intervention or the follow-up as usual group. Both groups will receive outcome measures at baseline and at 3, 6 and 12 months.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStructured support of caregivers at the ICUStructured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses

Timeline

Start date
2021-04-22
Primary completion
2024-10-21
Completion
2024-10-21
First posted
2021-04-09
Last updated
2025-05-31

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04839406. Inclusion in this directory is not an endorsement.