Strengthening Hope After ICU Discharge

University of Oslo (UIO)

Status: Enrolling

Conditions: Critical Care

Treatments: Behavioral: Hope Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06569901

542348

Details and patient eligibility

About

The goal of this clinical trial is to evaluate an interventional program that aims to strengthen hope in intensive care unit (ICU) patients in the rehabilitation phase. The main questions it aims to answer are:

To develop and implement a follow-up service to strengthen hope in ICU patients, and to evaluate the effect on hope in a stepped wedge randomized trial.

To identify possible predictive factors (facilitators and barriers) associated with hope.

Participants will be asked to take part in an ICU follow-up service, a "Hope Intervention" consisting of digital individual- and group conversations. The program will address topics that are important for hope, such as active involvement, social relationships, believes and thoughts of the future.

We will compare the level of hope between participants who have completed the "Hope Intervention" to those that have not yet completed the program.

Full description

The ICU patient's situation is challenging as they are acutely ill over a prolonged period of time and receive life sustaining treatment in the ICU.

Having hope and belief in a positive future, even when the prospects of such future are uncertain, may give strength and motivation and possibly improve the outcome in the rehabilitation phase. Hope is scarcely described in ICU patients.

Health care professionals need to learn how to best support ICU patients and promote hope during the rehabilitation period. Therefore, the main aim of the present study is to develop, implement and evaluate a follow up service to former ICU patients to strengthen their hope using a stepped wedge cluster randomized control intervention trial (SW-CRT). The secondary aim is to identify possible predictive factors associated with hope.

The intervention will start after hospital discharge and will be carried out in group sessions.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥18 years
• ICU patient for > 48 hours
• must be able to communicate verbally just after their ICU stay and be able to handle digital meetings

Exclusion criteria

• Patients with severe cognitive impairment
• Do not understand and speak Norwegian
• Patients with major psychiatric challenges, suicidal attempts as a reason for ICU stay
• Age over 85 years.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

75 participants in 5 patient groups

Cluster A

Experimental group

Description:

Cluster A will participate in the Hope Intervention shortly after randomization. Prior the intervention the participants will serve as controls.

Treatment:

Behavioral: Hope Intervention

Cluster B

Experimental group

Description:

Cluster B will participate in the Hope Intervention when Cluster A ends, approximately four weeks after randomization. Prior the intervention the participants will serve as controls.

Treatment:

Behavioral: Hope Intervention

Cluster C

Experimental group

Description:

Cluster C will participate in the Hope Intervention when Cluster B ends, approximately eight weeks after randomization. Prior the intervention the participants will serve as controls.

Treatment:

Behavioral: Hope Intervention

Cluster D

Experimental group

Description:

Cluster D will participate in the Hope Intervention when Cluster C ends, approximately 12 weeks after randomization. Prior the intervention the participants will serve as controls.

Treatment:

Behavioral: Hope Intervention

Cluster E

Experimental group

Description:

Cluster E will participate in the Hope Intervention when Cluster D ends, approximately 16 weeks after randomization. Prior the intervention the participants will serve as controls.

Treatment:

Behavioral: Hope Intervention