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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 181 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Holbaek Sygehus is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Ran from Dec 2012 to primary completion in Dec 2015, 36 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 36 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Holbaek Sygehus