NCT03915977

Brief Summary

This study aims to describe adult patients' patterns of Post-traumatic stress disorder (PTSD) at discharge, 3, and 12 months after intensive care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

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 2, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

August 9, 2019

Status Verified

December 1, 2012

Enrollment Period

3 years

First QC Date

April 12, 2019

Last Update Submit

August 7, 2019

Conditions

Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (1)

  • Post traumatic stress disorder (PTSD)

    Harvard Trauma Questionnaire, Range 18-72

    12 months

Secondary Outcomes (9)

  • Anxiety

    12 months

  • Anxiety

    3 months

  • Depression

    12 months

  • Depression

    3 months

  • PTSD

    Baseline

  • +4 more secondary outcomes

Interventions

Post ICU recovery programBEHAVIORAL

Standardized follow up program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intensive care patients (survivors)

You may qualify if:

  • Age ≥ 18 years
  • Non-invasive or invasive ventilation ≥ 48 hours ( Non-ivasive ventilation (NIV) from current guidelines)
  • Undiagnosed dementia

You may not qualify if:

  • Delirium at randomization (positive CAM-ICU score)
  • Participations in scientific projects which include patient interviews
  • Not speaking or understanding danish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holbæk Hospital

Holbæk, Region Sjælland, 4300, Denmark

Location

Related Publications (2)

  • Jensen JF, Overgaard D, Bestle MH, Christensen DF, Rattray J, Egerod I. Intervention fidelity in postintensive care follow-up consultations at ten sites in the RAPIT-trial: A mixed-methods evaluation. J Adv Nurs. 2019 Apr;75(4):862-875. doi: 10.1111/jan.13949. Epub 2019 Feb 12.

    PMID: 30644124BACKGROUND

  • 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: 27695894RESULT

Related Links

Study Officials

  • Janet F Jensen

    Holbaek Sygehus and Hillerod Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

December 2, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 9, 2019

Record last verified: 2012-12

Locations

DK(1)