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| ID | Type | Description | Link |
|---|---|---|---|
| NCT-01721239 | Other Identifier | Registry Identifier of RAPIT-I on ClinicalTrials.gov |
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| Name | Class |
|---|---|
| Nordsjaellands Hospital | OTHER |
| Herlev Hospital | OTHER |
| Horsens Hospital | OTHER |
| Nykøbing Falster County Hospital |
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Relatives of intensive care patients are at risk of developing symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired health-related quality of life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The hypothesis is that relatives to former intensive care patients will improve their HRQOL one year after intensive care. We want to determine whether relatives to former intensive care patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC) and symptoms of anxiety, depression and PTSD compared to standard care one year after intensive care.
Relatives of intensive care patients are affected of critical illness with symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired mental health. Recovery programs aimed at patients after a stay at the intensive care unit (ICU) have been tested and implemented, but the effectiveness is inconclusive, and on relatives sparse. The aim is to determine whether relatives to former intensive care patients benefits from a recovery programme with improved health-related quality of life (HRQOL), Sense Of Coherence (SOC), and symptoms of anxiety, depression, and PTSD compared to standard care during the first year after ICU discharge.
This was a sub-study of the "Recovery and Aftercare in Post-Intensive care Therapy patients" (RAPIT) trial; a pragmatic, non-blinded, multicentre, parallel-group, randomized controlled trial. We recruited patients and relatives concurrently during the RAPIT-trial study-period, and now we are doing analysis on relatives. We wants to include adult relatives defined by the patients from 10 Danish ICUs.
The study was powered to detect an effect size of a 5-point increase in the Medical Health Survey Short-Form 36 (SF-36) on the mental component score (MCS) in the intervention group at 12 months post-ICU. Power calculation was based on an expected distribution of MCS from a matched population with a mean of 36.7 (SD 11.7) from a similar study. With a statistical power of 80% and significance level of 0.05, we estimated that 86 relatives were needed in each group to complete follow-up.
The statistical analysis plan was based on intention-to-treat (ITT) as was per protocol (PP) analysis and investigating difference between intervention and controls. Relatives were considered to have received the intervention if the patient attended at least one of the three consultations, which accounted for the PP analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Relatives participated actively in the one out of three consultation conducted by trained study nurses at two months after intensive care superimposed on standard care. |
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| Standard care | No Intervention | Relatives to former ICU patients, who had received standard care (SC) completed a questionnaire package at 3 and 12 months after the patient was discharged from intensive care. After enrollment were all contract handled by primary investigator. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Intervention (plus standard care)
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| Measure | Description | Time Frame |
|---|---|---|
| Mental Component Score | Health-related Quality of life using Short-form-36 questionnaire | 12 months after ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Component Score | Health-related Quality of life using Short-form-36 questionnaire | 3 months after ICU |
| Physical Component Score | Health-related Quality of life using Short-form-36 questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RAPIT Steering Committee | Region of Copenhagen Capital and Region of Zealand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holbæk Hospital | Holbæk | Region Sjælland | 4300 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27695894 | Background | Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30. |
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Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2019 | |
| Reset | Jul 2, 2019 | |
| Release | Aug 6, 2019 | |
| Reset | Sep 11, 2019 | |
| Release | Sep 25, 2019 | |
| Reset | Oct 18, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2019 | Jul 2, 2019 | |||
| Aug 6, 2019 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| OTHER |
| Naestved Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Aabenraa Hospital | OTHER |
| Sonderborg Hospital | OTHER_GOV |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| Svendborg Hospital | OTHER |
Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial
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Data analyses
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| 3 months after ICU |
| Physical Component Score | Health-related Quality of life using Short-form-36 questionnaire | 12 months after ICU |
| Anxiety | Anxiety measured by Hospital Anxiety and Depression Scale (HADS) | 3 months after ICU |
| Anxiety | Anxiety measured by Hospital Anxiety and Depression Scale (HADS) | 12 months after ICU |
| Depression | Depression measured by Hospital Anxiety and Depression Scale (HADS) | 3 months after ICU |
| Depression | Depression measured by Hospital Anxiety and Depression Scale (HADS) | 12 months after ICU |
| Post-traumatic stress Disorders | Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV | 3 months after ICU |
| Post-traumatic stress Disorders | Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV | 12 months after ICU |
| Sense of coherence | Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire | 3 months after ICU |
| Sense of coherence | Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire | 12 months after ICU |
| Sep 11, 2019 |
| Sep 25, 2019 | Oct 18, 2019 |
| D000068099 |
| Trauma and Stressor Related Disorders |
| D017530 | Health Care Quality, Access, and Evaluation |