The Effectiveness of a Post-ICU Recovery Program on Relatives

Intensive Care Unit Syndrome Clinical Trial

— RAPIT-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264365
• Other study ID #: 01863 HIH-2012-011
• Secondary ID: NCT-01721239
• Status: Completed
• Phase: N/A
• First received: August 22, 2017
• Last updated: March 6, 2018
• Start date: December 15, 2012
• Est. completion date: March 6, 2018

Study information

• Verified date: March 2018
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: March 6, 2018
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome
• Relatives

Intervention

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

Locations

Country	Name	City	State
Denmark	Holbæk Hospital	Holbæk	Sjælland

Sponsors (11)

Lead Sponsor	Collaborator
Holbaek Sygehus	Aabenraa Hospital, Herlev Hospital, Horsens Hospital, Naestved Hospital, Nordsjaellands Hospital, Nykøbing Falster County Hospital, Rigshospitalet, Denmark, Sonderborg Hospital, Svendborg Hospital, Sydvestjysk Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. Epub 2016 Sep 30. — View Citation

Outcome

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