NCT03264365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

August 22, 2017

Last Update Submit

March 6, 2018

Conditions

Intensive Care Unit SyndromeRelatives

Keywords

Health-related quality of lifeAnxietyDepressionPost-traumatic stress disorderRecovery programmeRehabilitationFollow-up programmeAftercareRandomized controlled TrialMulticentre

Outcome Measures

Primary Outcomes (1)

  • Mental Component Score

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

    12 months after ICU

Secondary Outcomes (11)

  • Mental Component Score

    3 months after ICU

  • Physical Component Score

    3 months after ICU

  • Physical Component Score

    12 months after ICU

  • Anxiety

    3 months after ICU

  • Anxiety

    12 months after ICU

  • +6 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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.

Interventions

InterventionBEHAVIORAL

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

Also known as: Standard care
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Defined by the patients

You may not qualify if:

  • If the patients dropped out or died during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holbæk Hospital

Holbæk, Region Sjælland, 4300, Denmark

Location

Related 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. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.

    PMID: 27695894BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionStress Disorders, Post-Traumatic

Interventions

MethodsStandard of Care

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Investigative TechniquesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • RAPIT Steering Committee

    Region of Copenhagen Capital and Region of Zealand

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analyses
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 29, 2017

Study Start

December 15, 2012

Primary Completion

December 31, 2015

Study Completion

March 6, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

DK(1)