Critical CareNCT06569901
Strengthening Hope After ICU Discharge
A study testing Hope Intervention in people with Critical Care, run by Oslo University Hospital at 3 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Care
- What is being tested?
- Hope Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesNorway
- Study dates
- 10 Sep 2024to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites, 3 recruiting
- Not yet recruiting
Vestre Viken HF, Bærum Hospital
Drammen, Akershus
Hanne Birigit Alfheim, PhD, halfheim@vestreviken.no
- Not yet recruiting
Diakonhjemmet Hospital
Oslo
Annikken Hansson, +4722451500, annikken.hansson@diakonsyk.no
Julie Berntsen, MSc, +4722451500, juliejohanne.berntsen@diakonsyk.no
- Recruiting
Oslo University Hospital
Oslo
Kristin W Sunde, MSc, krflat@ous-hf.no
About this study
Official title: To Strengthen the Patients Hope After Discharge From the Intensive Care Unit - a Stepped Wedge Cluster Randomized Trial
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.
Read more
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.
Read the 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.
- Conditions
- Critical Care
- Being tested
- Hope Intervention
- Keywords
- Critical Care, Critical Illness, Critical Care Outcomes, Post-ICU, Hope, Intervention study
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cluster A | Experimental | Cluster A will participate in the Hope Intervention shortly after randomization. Prior the intervention the participants will serve as controls. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Hope Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1,2,3,4 and 5 months after baseline
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1,2,3,4 and 5 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start10 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Diakonhjemmet Hospital
- Responsible party
- Principal investigator, Tone Rustøen, Oslo University Hospital
- Investigators
- Tone Rustøen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569901
- Sponsor's protocol ID
- 542348
- Status last verified
- Sep 2024
- First submitted
- 15 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1430629Schneeweiss 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.
PubMed 12968819Broadbent 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.
PubMed 7126941Russell 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.
PubMed 6737214Portenoy 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.
PubMed 7999421Dufault 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.
PubMed 3846980
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Strengthen the Patients Hope After Discharge From the Intensive Care Unit - a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06569901
- Acronym / sponsor ID
- 542348
- Conditions
- Critical Care
- Keywords
- Critical Care, Critical Illness, Critical Care Outcomes, Post-ICU, Hope, Intervention study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Diakonhjemmet Hospital
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cluster A | Experimental | Behavioral: Hope InterventionCluster A will participate in the Hope Intervention shortly after randomization. Prior the intervention the participants will serve as controls. |
| Cluster B | Experimental | Behavioral: Hope InterventionCluster 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. |
| Cluster C | Experimental | Behavioral: Hope InterventionCluster 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. |
| Cluster D | Experimental | Behavioral: Hope InterventionCluster 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. |
| Cluster E | Experimental | Behavioral: Hope InterventionCluster 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hope InterventionGroup 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. | Behavioural | Cluster A, Cluster B, Cluster C, Cluster D, Cluster E |
Primary outcome
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.
5 secondary outcomes
Social Provsion Scale
Time frame: Baseline and 1,2,3,4 and 5 months after baseline
Charlson comorbidity Index
Time frame: Within 2 months after inclucion
Memorial Symptom Assessment Scale
Time frame: Baseline and 1,2,3,4 and 5 months after baseline
General Perceived Self-Efficacy Scale
Time frame: Baseline and 1,2,3,4 and 5 months after baseline
Cognitive Failure Questionnaire
Time frame: Baseline and 1,2,3,4 and 5 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 1430629Herth 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.
- Background: PubMed 12968819Schneeweiss 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.
- Background: PubMed 7126941Broadbent 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.
- Background: PubMed 6737214Russell 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.
- Background: PubMed 7999421Portenoy 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.
- Background: PubMed 3846980Dufault 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tone Rustøen, PhD principal investigator
Oslo University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hope Intervention in people with Critical Care, run by Oslo University Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin W Sunde, Msc (+4792095804, krflat@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hope (time frame: Baseline and 1,2,3,4 and 5 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06569901, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.