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| Name | Class |
|---|---|
| The Dam Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Structured follow up at the ICU
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| Follow up as usual (Control) | No Intervention | Follow up as usual at the ICU |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured support of caregivers at the ICU | Behavioral | Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 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). | Change from baseline to f-up month 6 |
| Anxiety and Depression |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Change from baseline to f-up month 3 |
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Inclusion Criteria:
Exclusion Criteria:
• None
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| Name | Affiliation | Role |
|---|---|---|
| Elin Børøsund, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37097744 | Background | 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. | |
| 39718436 | Result | Watland 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. |
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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). |
| 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). | Group differences at f-up month 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Group differences at f-up month 12 |