Post Traumatic Stress SymptomsFUTNCT02077244
Follow up After Intensive Care. The FUTstudy
A study testing Follow up talks in people with Post Traumatic Stress Symptoms and Post ICU Patient, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Symptoms, Post ICU Patient
- What is being tested?
- Follow up talks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2014to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effect of Nurse Led Follow up After Being a Patient in the Intensive Care Unit.
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.
- Conditions
- Post Traumatic Stress Symptoms, Post ICU Patient
- Being tested
- Follow up talks
- Keywords
- patient, intensive care, follow up, post traumatic stress symptoms, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up talksBehavioural
Nurse led follow up talks at the ward and one and two months later.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6 and 12 months after baseline
Secondary outcomes (4)
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.
Measured: 3, 6 and 12 months after baseline
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.
Measured: 3, 6 and 12 months after baseline
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.
Measured: 3, 6 and 12 months after baseline
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.
Measured: 3, 6 and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress SymptomsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsti Tøien, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077244
- Sponsor's protocol ID
- 2012/1715
- Acronym
- FUT
- Status last verified
- May 2018
- First submitted
- 28 Feb 2014
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effect of Nurse Led Follow up After Being a Patient in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT02077244
- Acronym / sponsor ID
- FUT / 2012/1715
- Conditions
- Post Traumatic Stress Symptoms, Post ICU Patient
- Keywords
- patient, intensive care, follow up, post traumatic stress symptoms, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Follow up talks | Experimental | Behavioral: Follow up talksPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up talksNurse led follow up talks at the ward and one and two months later. | Behavioural | Follow up talks |
Primary outcome
Post traumatic stress symptoms
Time frame: 3, 6 and 12 months after baseline
Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.
4 secondary outcomes
Sense of coherence (Sense of coherence scale 13)
Time frame: 3, 6 and 12 months after baseline
Health related quality of life
Time frame: 3, 6 and 12 months after baseline
Pain (Brief pain inventory)
Time frame: 3, 6 and 12 months after baseline
Work participation
Time frame: 3, 6 and 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up talks in people with Post Traumatic Stress Symptoms and Post ICU Patient, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic stress symptoms (time frame: 3, 6 and 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.