Intensive Care Unit Syndrome Clinical Trial
Official title:
The Effectiveness of a Post-ICU Recovery Program on Relatives to Patients Receiving Mechanically Ventilatory Support: Data Linked to RAPIT-I Investigation
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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