An interventional study of Intervention in Intensive Care Unit Syndrome and Relatives, sponsored by Holbaek Sygehus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Holbaek Sygehus · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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.
Behavioral: 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.
Intervention (plus standard care) * Patients photographs during the ICU-stay, * Written information about life after ICU * First consultation face-to-face in hospital setting at three months after ICU * Visit ICU and photographs given * Consultations as needed
Also known as: Standard care
Mental Component Score
Health-related Quality of life using Short-form-36 questionnaire
Time frame: 12 months after ICU
Mental Component Score
Health-related Quality of life using Short-form-36 questionnaire
Time frame: 3 months after ICU
Physical Component Score
Health-related Quality of life using Short-form-36 questionnaire
Time frame: 3 months after ICU
Physical Component Score
Health-related Quality of life using Short-form-36 questionnaire
Time frame: 12 months after ICU
Anxiety
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months after ICU
Anxiety
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months after ICU
Depression
Depression measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months after ICU
Depression
Depression measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months after ICU
Post-traumatic stress Disorders
Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
Time frame: 3 months after ICU
Post-traumatic stress Disorders
Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
Time frame: 12 months after ICU
Sense of coherence
Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
Time frame: 3 months after ICU
Sense of coherence
Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
Time frame: 12 months after ICU
Plan to share: Undecided — Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Holbaek Sygehus