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Clinical Trials/NCT06569901
NCT06569901
Not Yet Recruiting
N/A

To Strengthen the Patients Hope After Discharge From the Intensive Care Unit - a Stepped Wedge Cluster Randomized Trial

Oslo University Hospital3 sites in 1 country75 target enrollmentAugust 2024
ConditionsCritical Care

Overview

Phase
N/A
Intervention
Not specified
Conditions
Critical Care
Sponsor
Oslo University Hospital
Enrollment
75
Locations
3
Primary Endpoint
Hope
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2024
End Date
September 2030
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tone Rustøen

Reseacher, Professor

Oslo University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Hope

Time Frame: Baseline and 1,2,3,4 and 5 months after baseline

Level of hope will be measured by Herth Hope Index (HHI). Baseline is measured after the patient has been discharged from the hospital. The HHI consists of 12 items measuring levels of hope related to cognitive and affective factors. Item scores range from 1 (strongly disagree) to 4 (strongly agree) and the total score ranges from 12 to 48. A high score indicates higher level of hope.

Secondary Outcomes

  • General Perceived Self-Efficacy Scale(Baseline and 1,2,3,4 and 5 months after baseline)
  • Cognitive Failure Questionnaire(Baseline and 1,2,3,4 and 5 months after baseline)
  • Memorial Symptom Assessment Scale(Baseline and 1,2,3,4 and 5 months after baseline)
  • Social Provsion Scale(Baseline and 1,2,3,4 and 5 months after baseline)
  • Charlson comorbidity Index(Within 2 months after inclucion)

Study Sites (3)

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