Follow up After Intensive Care. The FUTstudy

NCT02077244 | Completed

• 1 other identifier: 2012/1715
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Symptoms; Post ICU Patient

Keywords

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

Outcome Measures

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.

  3, 6 and 12 months after baseline

Secondary Outcomes (4)

• Sense of coherence (Sense of coherence scale 13)

  3, 6 and 12 months after baseline

• Health related quality of life

  3, 6 and 12 months after baseline

• Pain (Brief pain inventory)

  3, 6 and 12 months after baseline

• Work participation

  3, 6 and 12 months after baseline

Study Arms (3)

Follow up talks

EXPERIMENTAL

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 talks

NO INTERVENTION

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

Observation group

NO INTERVENTION

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

Interventions

Follow up talks BEHAVIORAL

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

Follow up talks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• severe psychiatric disorder

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD post doctor fellow

Model Details: Those who give their written informed consent will fill out the Post Traumatic Stress Scale 10 Intensive care screen (PTSS 10-I) Patients with a score equal or above 25 (indicating suffering from PTS symptoms) will be randomized to intervention or control group. Randomization will be performed using the computer program WebCRFNTNU. Patients who score below 25 will be included in an observation group and receive questionnaires at the same time points as the intervention and control group. To be able to detect a difference of 10 between the groups as significant with 80% power and allow for 20% dropout, a total of 250 patients with PTS-10 score like or above 25 have to be included in the randomized part of the study. In the autum 2016 a new statistician in the procject recalculated the power and found the need for 134 randomized patients. The inclusion was then terminated.

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: January 8, 2019

Record last verified: 2018-05

Locations

NO (1)