Strengthening Hope After ICU Discharge
NCT Number: NCT06569901
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Care
Interventions: BEHAVIORAL: Hope Intervention
Sponsor: Oslo University Hospital
Collaborators: Vestre Viken Hospital Trust|Diakonhjemmet Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2030-09
Locations: Vestre Viken HF, Bærum Hospital, Drammen, Akershus, Norway|Diakonhjemmet Hospital, Oslo, Norway|Oslo University Hospital, Oslo, Norway

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.

Primary Outcome Measures: Hope, 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., Baseline and 1,2,3,4 and 5 months after baseline
Secondary Outcome Measures: Social Provsion Scale, Level of social support will be measured by Social Provision Scale (SPS). Baseline is measured after hospital discharge. The SPS consists of 16 assertions about social support that may apply to the individual. Item scores options are; strongly disagree, disagree, agree, and strongly agree.

The total score ranges from 16-64, and a high score indicates a high level of social support., Baseline and 1,2,3,4 and 5 months after baseline|Charlson comorbidity Index, Data on comorbidity will be measured with Charlson comorbidity Index (CCI) , collected from the medical record.

The CCI categorize the patients' comorbidities and each comorbidity has an associated weight (from 1 to 6). The total scor ranges from 0-37, and the higher the score, the more likely the predicted outcome will result in mortality., Within 2 months after inclucion|Memorial Symptom Assessment Scale, Level of symptoms is measured by Memorial Symptom Assessment Scale (MSAS). MSAS consist of 28 predefined symptomes, were 0 indicated not having the symptom and 1 indicates having the symptom. Maximum number of predefined symptoms is 28, and indicates a worse outcome. If the respondent answers "yes" on a symptom, they are asked at what time the symptom occured, and to rate the severity and distress of the symptom using a numeric rating scale from 0 to 10. Zero indicating "not at all" and 10 "very much". A higher score indicates a worse outcome.

Baseline is measured after hospital discharge., Baseline and 1,2,3,4 and 5 months after baseline|General Perceived Self-Efficacy Scale, Level of a general sense of perceived self-efficacy is measured by General Perceived Self-Efficacy Scale (GSE).The short-form scale consists of items, and each item scores on a 4-point scale from 1 (not at all true) to 4 (exactly true). Total score ranges from 5-20, where high scores reflect courage and perseverance and coping both with daily hassles and stressful life events Baseline is measured after hospital discharge., Baseline and 1,2,3,4 and 5 months after baseline|Cognitive Failure Questionnaire, Level of cognitive function is measured by the Cognitive Failure Questionnaire (CFQ).

The questionnaire has five responses from "never" (0) to "very often" (4). A lower score indicates better cognition.

Baseline is measured after hospital discharge., Baseline and 1,2,3,4 and 5 months after baseline