The Effectiveness of a Post-ICU Recovery Program on Relatives

Not Applicable

Completed

• Conditions: Intensive Care Unit Syndrome; Relatives
• Interventions: Behavioral: Intervention

• Registration Number: NCT03264365
• Lead Sponsor: Holbaek Sygehus

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.

Study Timeline

• Study Start: 2012-12-15
• Primary Completion: 2015-12-31
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-29
• Status Verified: 2018-03
• Study Completion: 2018-03-06
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	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.

Primary Outcome Measures

Name	Time	Method
Mental Component Score	12 months after ICU	Health-related Quality of life using Short-form-36 questionnaire

Secondary Outcome Measures

Name	Time	Method
Mental Component Score	3 months after ICU	Health-related Quality of life using Short-form-36 questionnaire
Physical Component Score	12 months after ICU	Health-related Quality of life using Short-form-36 questionnaire
Anxiety	12 months after ICU	Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Depression	12 months after ICU	Depression measured by Hospital Anxiety and Depression Scale (HADS)
Post-traumatic stress Disorders	12 months after ICU	Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
Sense of coherence	12 months after ICU	Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire

Trial Locations

Locations (1)

Holbæk Hospital; 🇩🇰 Holbæk, Sjælland, Denmark