The Effectiveness of a Post-ICU Recovery Program on Relatives

Study Overview
=================
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.

Official Title
-----------------
The Effectiveness of a Post-ICU Recovery Program on Relatives to Patients Receiving Mechanically Ventilatory Support: Data Linked to RAPIT-I Investigation

Conditions
-----------------
Relatives, Intensive Care Unit Syndrome

Intervention / Treatment
-----------------
* Behavioral: Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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<br>* Other names: Standard care;|
| No Intervention: Standard care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Component Score | Health-related Quality of life using Short-form-36 questionnaire | 12 months after ICU | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health-related quality of life, Anxiety, Depression, Post-traumatic stress disorder, Recovery programme, Rehabilitation, Follow-up programme, Aftercare, Randomized controlled Trial, Multicentre