Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03264365
Study type Interventional
Source Holbaek Sygehus
Contact
Status Completed
Phase N/A
Start date December 15, 2012
Completion date March 6, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06277518 - System for Postoperative Admission to ICU for Patients With Digestive System Malignancy
Completed NCT06251791 - Inspiratory Muscle Training and Expiratory Muscle Thickness N/A
Not yet recruiting NCT03247062 - Sleep Bundle for Improving Sleep in ICU Patients N/A
Completed NCT04110509 - Fragility and Programmed Cardiovascular Surgery (EcoSarco)
Recruiting NCT05587595 - Transition From Paediatric Intensive Care to General Paediatrics and Pneumology Units : a Study of the Post-intensive Care Syndrome
Active, not recruiting NCT05299346 - Post-ICU Follow-up Study in Covid-19 Patients
Recruiting NCT04112420 - Detection of the Incidence of Pre-existing Cardio-pulmonary Diseases by Using of Echocardiography N/A
Recruiting NCT05491590 - Patient-reported Outcome After Status Epilepticus
Recruiting NCT05155150 - Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information N/A
Completed NCT03642249 - Education for Recognition and Management of Delirium N/A
Withdrawn NCT03138278 - Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old. N/A
Completed NCT02784574 - Post ICU Follow up: A Questionnaire Survey of Aftercare in Denmark N/A
Completed NCT04412980 - Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD
Completed NCT04378504 - In Hospital Course of Acute Coronary Artery Syndromes
Completed NCT03124342 - Vanderbilt ICU Recovery Program Pilot Trial N/A
Completed NCT03457376 - Correlation of the Hand Grip Force With Maximum Inspiratory and Maximum Expiratory Pressure, in Critical Ill Patients N/A
Completed NCT03885687 - Exercise With Music for ICU Survivors N/A
Completed NCT03828552 - Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.
Completed NCT03392857 - End Of Life in the Critically Ill patiEnt
Recruiting NCT05795569 - Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial N/A