Strengthening Hope After ICU Discharge

NCT06569901 | Recruiting

• 1 other identifier: 542348
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Care

Keywords

Critical Care; Critical Illness; Critical Care Outcomes; Post-ICU; Hope; Intervention study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Social Provsion Scale

  Baseline and 1,2,3,4 and 5 months after baseline

• Charlson comorbidity Index

  Within 2 months after inclucion

• Memorial Symptom Assessment Scale

  Baseline and 1,2,3,4 and 5 months after baseline

• 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

Study Arms (5)

Cluster A

EXPERIMENTAL

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

Behavioral: Hope Intervention

Cluster B

EXPERIMENTAL

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.

Behavioral: Hope Intervention

Cluster C

EXPERIMENTAL

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.

Behavioral: Hope Intervention

Cluster D

EXPERIMENTAL

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.

Behavioral: Hope Intervention

Cluster E

EXPERIMENTAL

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.

Behavioral: Hope Intervention

Interventions

Hope Intervention BEHAVIORAL

Group meetings after hospital discharge reflecting on themes that may have an impact on hope. The Hope Intervention consists of four group meetings and two individual conversations during a four week period.

Cluster A; Cluster B; Cluster C; Cluster D; Cluster E

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Vestre Viken Hospital Trust: collaborator
• Diakonhjemmet Hospital: collaborator

Study Sites (3)

Vestre Viken HF, Bærum Hospital

Drammen, Akershus, Norway

NOT YET RECRUITING

Diakonhjemmet Hospital

Oslo, Norway

NOT YET RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Publications (6)

• Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.

  PMID: 1430629 BACKGROUND

• Schneeweiss S, Wang PS, Avorn J, Glynn RJ. Improved comorbidity adjustment for predicting mortality in Medicare populations. Health Serv Res. 2003 Aug;38(4):1103-20. doi: 10.1111/1475-6773.00165.

  PMID: 12968819 BACKGROUND

• Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.

  PMID: 7126941 BACKGROUND

• Russell D, Cutrona CE, Rose J, Yurko K. Social and emotional loneliness: an examination of Weiss's typology of loneliness. J Pers Soc Psychol. 1984 Jun;46(6):1313-21. doi: 10.1037//0022-3514.46.6.1313.

  PMID: 6737214 BACKGROUND

• Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.

  PMID: 7999421 BACKGROUND

• Dufault K, Martocchio BC. Symposium on compassionate care and the dying experience. Hope: its spheres and dimensions. Nurs Clin North Am. 1985 Jun;20(2):379-91.

  PMID: 3846980 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tone Rustøen, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin W Sunde, Msc

CONTACT

+4792095804; krflat@ous-hf.no

Hanne Birgit Alfheim, PhD

CONTACT

+4767509017; halfheim@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reseacher, Professor

Model Details: After recruitment of 25 participants, they will be randomized into five clusters. One cluster at a time, will cross over to the intervention group. This recruitment period will be repeated three times to include a total of 75 participants. Prior the intervention, participants will receive "care as usual" and serve as controls.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 26, 2024
• Study Start: September 10, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)