Clinical trial NCT03264365: The Effectiveness of a Post-ICU Recovery Program on Relatives
Official title: The Effectiveness of a Post-ICU Recovery Program on Relatives to Patients Receiving Mechanically Ventilatory Support: Data Linked to RAPIT-I Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Relatives
Keywords: Health-related quality of life
Anxiety
Depression
Post-traumatic stress disorder
Recovery programme
Rehabilitation
Follow-up programme
Aftercare
Randomized controlled Trial
Multicentre
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Nordsjaellands Hospital
name: Herlev Hospital
name: Horsens Hospital
name: Nykøbing Falster County Hospital
name: Naestved Hospital
name: Rigshospitalet, Denmark
name: Aabenraa Hospital
name: Sonderborg Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Svendborg Hospital
First posted: 2017-08-29
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Defined by the patients

Exclusion Criteria:

* If the patients dropped out or died during the study period

Primary outcomes:
measure: Mental Component Score
timeFrame: 12 months after ICU
Secondary outcomes:
measure: Mental Component Score
timeFrame: 3 months after ICU
measure: Physical Component Score
timeFrame: 3 months after ICU
measure: Physical Component Score
timeFrame: 12 months after ICU
measure: Anxiety
timeFrame: 3 months after ICU
measure: Anxiety
timeFrame: 12 months after ICU
measure: Depression
timeFrame: 3 months after ICU
measure: Depression
timeFrame: 12 months after ICU
measure: Post-traumatic stress Disorders
timeFrame: 3 months after ICU
measure: Post-traumatic stress Disorders
timeFrame: 12 months after ICU
measure: Sense of coherence
timeFrame: 3 months after ICU
measure: Sense of coherence
timeFrame: 12 months after ICU
Other outcomes:
Locations:
city: Holbæk
country: Denmark
facility: Holbæk Hospital
state: Sjælland
Study officials:
affiliation: Region of Copenhagen Capital and Region of Zealand
name: RAPIT Steering Committee
role: STUDY_CHAIR
References:
citation: 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.