Caregiver Stress SyndromeNCT04839406
The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
A study testing Structured support of caregivers at the ICU in people with Caregiver Stress Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress Syndrome
- What is being tested?
- Structured support of caregivers at the ICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteNorway
- Study dates
- 22 Apr 2021to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers of patients admitted to the intensive care unit that is expected to receive invasive mechanical ventilation for at least 48 hours
- Between 18 and 70 years old
- Able to understand and speak Norwegian
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial.
Read the detailed description
Caregivers of patients admitted to an intensive care unit (ICU) often experience the situation as traumatic and stressful. Long term consequences such as fatigue, anxiety, depression and symptoms of post-traumatic stress are reported among 30-50 percent of the caregivers of critically ill patients. The need for supportive interventions is called for.
The overall goal of this project is to improve the support for caregivers of intensive care patients. A systematic intervention for individual support of caregivers, The Caregiver Pathway Intervention, has been developed with a multidisciplinary approach, based on existing evidence, through interviews with former caregivers, workshops with health care personnel and user input and testing. The intervention consist of mapping of caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues, a structured conversation at discharge, and an invitation to a follow-up conversation 4-6 weeks after discharge/patients death.
The aim of the project is to test the efficacy of The Caregiver Pathway Intervention among caregivers at the ICU in a randomized controlled trial, using outcome measures such as symptoms of post-traumatic stress, anxiety/depression, cost-utility measures and health-related quality of life. The participants will be randomly assigned to The Caregiver Pathway Intervention or the follow-up as usual group. Both groups will receive outcome measures at baseline and at 3, 6 and 12 months.
- Conditions
- Caregiver Stress Syndrome
- Being tested
- Structured support of caregivers at the ICU
- Keywords
- Caregivers, Post traumatic stress, Health related quality of life, Intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured support of caregivers at the ICUBehavioural
Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Structured follow up at the ICU
* 1-3 days after admittance: Map caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues.
* Every 1-2 weeks: Repeat assessment of symptoms and needs with the assessment tool followed by a meeting with a nurse.
* At discharge: Structured conversation focusing on information and preparation for the transition to a regular ward or to another hospital including a card with information and support.
* Bereavement: Individualized support based on caregiver expressed needs, preferences and previous mapping, including a card with information and support.
* Follow up: Caregivers or bereaved will be contacted after 4-6 weeks, and will be offered a follow up conversation either on phone or at the unit. Receives: Behavioral: Structured support of caregivers at the ICU |
| Follow up as usual (Control) | No intervention | Follow up as usual at the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic stress
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Measured: Group differences at f-up month 3
Post traumatic stress
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Measured: Group differences at f-up month 6
Post traumatic stress
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Measured: Group differences at f-up month 12
Anxiety and Depression
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale.
Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Measured: Change from baseline to f-up month 3
Anxiety and Depression
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale.
Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Measured: Change from baseline to f-up month 6
Anxiety and Depression
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale.
Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Measured: Change from baseline to f-up month 12
Quality Adjusted Life Years (QUALYs)
Quality Adjusted Life Years (QUALYs), an economic evaluation of the quality and quantity of life lived, will be derived from the RAND-12 (Short form health survey, developed by the non profit RAND corporation). QUALY scores range from 1 (perfect health) to 0 (death).
Measured: Group differences at f-up month 12
Secondary outcomes (12)
Health related quality of life
Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability).
Measured: Change from baseline to f-up month 3
Health related quality of life
Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability).
Measured: Change from baseline to f-up month 6
Health related quality of life
Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability).
Measured: Change from baseline to f-up month 12
Hope
Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope.
Measured: Change from baseline to f-up month 3
Hope
Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope.
Measured: Change from baseline to f-up month 6
Hope
Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope.
Measured: Change from baseline to f-up month 12
Self-Efficacy.
Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy.
Measured: Change from baseline to f-up month 3
Self-Efficacy.
Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy.
Measured: Change from baseline to f-up month 6
Self-Efficacy.
Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy.
Measured: Change from baseline to f-up month 12
Caregiver satisfaction.
Caregiver satisfaction will be mesured with the Family satisfaction in the ICU questionnaire (FS-ICU-24). Score range: 0-100, a higher score indicates more satisfaction.
Measured: Group differences at f-up month 3
Caregivers burden
The Caregiver Reaction Assessment (CRA). Summary score range between 5 and 120. A higher score indicates a higher level of burden.
Measured: Group differences at f-up month 12
Complicated grief
Complicated grief will be measured with the Inventory of Complicated Grief (ICG). Summary score range between 0-76, and a higher score indicates risk of complicated grief.
Measured: Group differences at f-up month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start22 Apr 2021
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caregiver Stress SyndromeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation
- Responsible party
- Principal investigator, Elin Børøsund, Oslo University Hospital
- Investigators
- Elin Børøsund, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839406
- Sponsor's protocol ID
- 199446
- Status last verified
- May 2025
- First submitted
- 24 Mar 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watland S, Solberg Nes L, Hanson E, Ekstedt M, Stenberg U, Borosund E. The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study. JMIR Form Res. 2023 Apr 25;7:e46299. doi: 10.2196/46299.
PubMed 37097744Watland S, Solberg Nes L, Ekeberg O, Rostrup M, Hanson E, Ekstedt M, Stenberg U, Hagen M, Borosund E. The Caregiver Pathway Intervention Can Contribute to Reduced Post-Intensive Care Syndrome Among Family Caregivers of ICU Survivors: A Randomized Controlled Trial. Crit Care Med. 2025 Mar 1;53(3):e555-e566. doi: 10.1097/CCM.0000000000006546. Epub 2024 Dec 24.
PubMed 39718436
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04839406
- Acronym / sponsor ID
- 199446
- Conditions
- Caregiver Stress Syndrome
- Keywords
- Caregivers, Post traumatic stress, Health related quality of life, Intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 9 Apr 2021 (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 aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial.
Detailed description
Caregivers of patients admitted to an intensive care unit (ICU) often experience the situation as traumatic and stressful. Long term consequences such as fatigue, anxiety, depression and symptoms of post-traumatic stress are reported among 30-50 percent of the caregivers of critically ill patients. The need for supportive interventions is called for.
The overall goal of this project is to improve the support for caregivers of intensive care patients. A systematic intervention for individual support of caregivers, The Caregiver Pathway Intervention, has been developed with a multidisciplinary approach, based on existing evidence, through interviews with former caregivers, workshops with health care personnel and user input and testing. The intervention consist of mapping of caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues, a structured conversation at discharge, and an invitation to a follow-up conversation 4-6 weeks after discharge/patients death.
The aim of the project is to test the efficacy of The Caregiver Pathway Intervention among caregivers at the ICU in a randomized controlled trial, using outcome measures such as symptoms of post-traumatic stress, anxiety/depression, cost-utility measures and health-related quality of life. The participants will be randomly assigned to The Caregiver Pathway Intervention or the follow-up as usual group. Both groups will receive outcome measures at baseline and at 3, 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Structured support of caregivers at the ICUStructured follow up at the ICU * 1-3 days after admittance: Map caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues. * Every 1-2 weeks: Repeat assessment of symptoms and needs with the assessment tool followed by a meeting with a nurse. * At discharge: Structured conversation focusing on information and preparation for the transition to a regular ward or to another hospital including a card with information and support. * Bereavement: Individualized support based on caregiver expressed needs, preferences and previous mapping, including a card with information and support. * Follow up: Caregivers or bereaved will be contacted after 4-6 weeks, and will be offered a follow up conversation either on phone or at the unit. |
| Follow up as usual (Control) | No intervention | –Follow up as usual at the ICU |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caregivers of patients admitted to the intensive care unit that is expected to receive invasive mechanical ventilation for at least 48 hours
- Between 18 and 70 years old
- Able to understand and speak Norwegian
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Structured support of caregivers at the ICUStructured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses | Behavioural | Intervention |
Primary outcome
Post traumatic stress
Time frame: Group differences at f-up month 3
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Post traumatic stress
Time frame: Group differences at f-up month 6
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Post traumatic stress
Time frame: Group differences at f-up month 12
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Anxiety and Depression
Time frame: Change from baseline to f-up month 3
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Anxiety and Depression
Time frame: Change from baseline to f-up month 6
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Anxiety and Depression
Time frame: Change from baseline to f-up month 12
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Quality Adjusted Life Years (QUALYs)
Time frame: Group differences at f-up month 12
Quality Adjusted Life Years (QUALYs), an economic evaluation of the quality and quantity of life lived, will be derived from the RAND-12 (Short form health survey, developed by the non profit RAND corporation). QUALY scores range from 1 (perfect health) to 0 (death).
12 secondary outcomes
Health related quality of life
Time frame: Change from baseline to f-up month 3
Health related quality of life
Time frame: Change from baseline to f-up month 6
Health related quality of life
Time frame: Change from baseline to f-up month 12
Hope
Time frame: Change from baseline to f-up month 3
Hope
Time frame: Change from baseline to f-up month 6
Hope
Time frame: Change from baseline to f-up month 12
Self-Efficacy.
Time frame: Change from baseline to f-up month 3
Self-Efficacy.
Time frame: Change from baseline to f-up month 6
Self-Efficacy.
Time frame: Change from baseline to f-up month 12
Caregiver satisfaction.
Time frame: Group differences at f-up month 3
Caregivers burden
Time frame: Group differences at f-up month 12
Complicated grief
Time frame: Group differences at f-up month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 37097744Watland S, Solberg Nes L, Hanson E, Ekstedt M, Stenberg U, Borosund E. The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study. JMIR Form Res. 2023 Apr 25;7:e46299. doi: 10.2196/46299.
- Results publication: PubMed 39718436Watland S, Solberg Nes L, Ekeberg O, Rostrup M, Hanson E, Ekstedt M, Stenberg U, Hagen M, Borosund E. The Caregiver Pathway Intervention Can Contribute to Reduced Post-Intensive Care Syndrome Among Family Caregivers of ICU Survivors: A Randomized Controlled Trial. Crit Care Med. 2025 Mar 1;53(3):e555-e566. doi: 10.1097/CCM.0000000000006546. Epub 2024 Dec 24.
- Individual participant dataSharing planned: No
Related trials for Caregiver Stress Syndrome
Recruiting
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Neurofibromatosis 1, Noonan Syndrome
Not yet recruitingObservational study
Patients With Long-stay at ICU: Factors and Evaluation - Feasibility Study
Frailty, Delirium Confusional State
RecruitingObservational study
Teleneurology Assessment Program for Creutzfeldt-Jakob Disease
Creutzfeldt-Jakob Disease (CJD) | Prion Disease
Not yet recruiting
Effectiveness of Stress Management Training in Reducing Caregiver Burden and Perceived Stress in ICU Families
Intensive Care Unit Syndrome, Critical Illness
RecruitingObservational study
Assessment of Cancer-related Post-traumatic Stress in Patients and Caregivers in the Year Following Diagnosis, and Identification of Their Expectations of Personalized Support - CANDYSTRESS
Cancer, Healthcare Professionnals
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. This study is not recruiting at the moment.
Elin Børøsund, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured support of caregivers at the ICU in people with Caregiver Stress Syndrome, run by Oslo University Hospital at 1 site 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 1 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: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic stress (time frame: Group differences at f-up month 3). The study lists 7 primary outcomes in all. 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 NCT04839406, which also lists 2 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 31 May 2025.