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NCT Number: NCT03264365

The Effectiveness of a Post-ICU Recovery Program on Relatives

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.

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Key information

Conditions

Intensive Care Unit Syndrome Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Relatives Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holbæk Hospital

Holbæk, Region Sjælland, 4300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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

Primary outcomes

  1. Mental Component Score

    Time frame: 12 months after ICU

    Health-related Quality of life using Short-form-36 questionnaire

Secondary outcomes

  1. Mental Component Score

    Time frame: 3 months after ICU

    Health-related Quality of life using Short-form-36 questionnaire

  2. Physical Component Score

    Time frame: 3 months after ICU

    Health-related Quality of life using Short-form-36 questionnaire

  3. Physical Component Score

    Time frame: 12 months after ICU

    Health-related Quality of life using Short-form-36 questionnaire

  4. Anxiety

    Time frame: 3 months after ICU

    Anxiety measured by Hospital Anxiety and Depression Scale (HADS)

  5. Anxiety

    Time frame: 12 months after ICU

    Anxiety measured by Hospital Anxiety and Depression Scale (HADS)

  6. Depression

    Time frame: 3 months after ICU

    Depression measured by Hospital Anxiety and Depression Scale (HADS)

  7. Depression

    Time frame: 12 months after ICU

    Depression measured by Hospital Anxiety and Depression Scale (HADS)

  8. Post-traumatic stress Disorders

    Time frame: 3 months after ICU

    Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV

  9. Post-traumatic stress Disorders

    Time frame: 12 months after ICU

    Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV

  10. Sense of coherence

    Time frame: 3 months after ICU

    Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire

  11. Sense of coherence

    Time frame: 12 months after ICU

    Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • Aabenraa Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Herlev Hospital
  • Horsens Hospital
  • Naestved Hospital
  • Nordsjaellands Hospital
  • Nykøbing Falster County Hospital
  • Rigshospitalet, Denmark
  • Sonderborg Hospital
  • Svendborg Hospital

Registry information

Official study title

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

Acronym: RAPIT-II

Important dates

Study start
2012
Primary completion
2015
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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