The Effectiveness of a Post-ICU Recovery Program on Relatives (RAPIT-II)

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.

Study Overview

• Status: Completed
• Conditions: Relatives; Intensive Care Unit Syndrome
• Intervention / Treatment: Behavioral: Intervention

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 Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Sjælland
    • Holbæk, Sjælland, Denmark, 4300
      • Holbæk Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Intervention; 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; Other Names: Standard care
No Intervention: Standard care; 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

Collaborators and Investigators

• Sponsor: Holbaek Sygehus
• Collaborators: Rigshospitalet, Denmark; Herlev Hospital; Svendborg Hospital; Naestved Hospital; Nykøbing Falster County Hospital; Sonderborg Hospital; Hospital of South West Jutland; Horsens Hospital; Nordsjaellands Hospital; Aabenraa Hospital
• Investigators: Study Chair: RAPIT Steering Committee, Region of Copenhagen Capital and Region of Zealand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2012
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): March 6, 2018

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Depression; Anxiety; Health-related quality of life; Post-traumatic stress disorder; Multicentre; Aftercare; Recovery programme; Follow-up programme; Randomized controlled Trial
• Other Study ID Numbers: 01863 HIH-2012-011; NCT-01721239 (Other Identifier: Registry Identifier of RAPIT-I on ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No