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CompletedNCT02077244FUTUpdated Jan 8, 2019

Follow up After Intensive Care. The FUTstudy

An interventional study of Follow up talks in Post Traumatic Stress Symptoms and Post ICU Patient, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-08.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To investigate the effect of nurse led follow up talks to prevent posttraumatic stress (PTS) symptoms and improve quality of life and sence of coherence after an intensive care unit (ICU) stay.

Secondly:

Investigate level of psychological distress, quality of life, hope and work participation in ICU patients after an ICU stay and factors associated with these outcomes.

Read the detailed description

The ICU patient experiences total dependence on health care professionals and technical devices. Some patients report unpleasant memories such as pain, feeling helpless, or delusional experiences from the ICU stay and many report physical or mental symptoms after discharge from the ICU. Return to work rate after ICU treatment differs. Most ICU patients receive analgesics and sedatives to relieve pain and discomfort during the stay. Thus many patients have few memories from their time being critically ill. For patients with few memories from the ICU stay this represents an interruption in the patient's life history. Since personal identity is influenced by the stories we tell about ourselves, loss of memory from a period with critical illness might be experienced as a threat towards self-confidence and sense of coherence. Some patients with traumatic memories from the ICU develop PTS symptoms after discharge.

In order to help the earlier ICU patient to achieve a life with less physical and mental complaints, some ICUs have established a follow up program in outpatient clinics after discharge from hospital, but there is sparse evidence of the effectiveness of this intervention, and what type of follow up that best help the patients.

The primary aim of the study is to:

Investigate if a group of previous intensive care patients receiving nurse led follow up talks three times after discharge from the ICU have less post traumatic stress symptoms, pain, increased sense of coherence and, work participation and health related quality of life (HRQL) three, six and twelve months after discharge from the ICU compared to a control group receiving standard care.

Secondary aim:

Investigate level and predictors of anxiety, depression, PTS symptoms, hope, pain, HRQOL and work participation in intensive care patients ICU patients first year after discharge from ICU.

02

Conditions studied

  • Post Traumatic Stress Symptoms
  • Post ICU Patient

Keywords

  • patient
  • intensive care
  • follow up
  • post traumatic stress symptoms
  • randomized controlled trial
03

In context

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients with an ICU stay like or above 24 hours who speak and understand Norwegian and who are conscious and cognitively oriented at the time of inclusion. Patients with a score of 25 or more on Post Traumatic Stress Scale 10 (PTSS-10) is randomized to intervention or control group. Patients with a score below 25 on PTSS-10 is included in an observation group.

Exclusion criteria

Exclusion Criteria:

  • severe psychiatric disorder
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (actual)

Study arms

  • Experimental
    Follow up talks

    Patients with a score like or above 25 on Post traumatic stress scale-10 Intensive Care Screen after discharge from the ICU. Nurse led follow up talks at the ward and one and two months later.

    Behavioral: Follow up talks

  • No intervention
    No talks

    Patients with a score like or above 25 on Post traumatic stress scale-10 Intensive Care Screen after discharge from the ICU. Care as usual

  • No intervention
    Observation group

    Patients with a score below 25 on Post traumatic stress scale-10 Intensive Care Screen after discharge from the ICU. Care as usual.

Interventions

  • BehavioralFollow up talks

    Nurse led follow up talks at the ward and one and two months later.

06

What researchers measure

Primary outcomes

  1. Post traumatic stress symptoms

    Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.

    Time frame: 3, 6 and 12 months after baseline

Secondary outcomes

  1. Sense of coherence (Sense of coherence scale 13)

    Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.

    Time frame: 3, 6 and 12 months after baseline

  2. Health related quality of life

    Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.

    Time frame: 3, 6 and 12 months after baseline

  3. Pain (Brief pain inventory)

    Baseline is measured when the patient has been discharged from the ICU to a ward before leaving the hospital. Change from baseline at 3, 6 and 12 months.

    Time frame: 3, 6 and 12 months after baseline

  4. Work participation

    Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.

    Time frame: 3, 6 and 12 months after baseline

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, 0424, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02077244
Lead sponsor
Oslo University Hospital
Responsible party
Kirsti Tøien (PhD post doctor fellow, Oslo University Hospital) — Principal investigator
First posted
Mar 4, 2014
Start date
Mar 2014
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Jan 8, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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