Stress Disorders, Post-TraumaticNCT02357680
Diaries for Critically Ill Patients Written by Relatives
A study testing Diary in people with Stress Disorders, Post-Traumatic and Anxiety, run by Hospitalsenheden Vest at 2 sites in Denmark.
Trial summary
This study will investigate the effect of diaries written by relatives for critically ill patients on the risk of posttraumatic stress symptoms. Utilizing a randomized controlled design pairs of one patient and one relative will be assigned to either diary intervention or standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- What is being tested?
- Diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Mar 2015to 31 Oct 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
- Patients:
- Expected to stay in ICU > 48 hours
- Expected to be on ventilator > 24 hours
- Has a close relative > 18 years old
- Speaking and understanding Danish.
- Expected to be able to deliver an informed consent later
Show all 9Show fewer
- Relative:
- Speaking and understanding Danish
- Relative and patient are included in the study as a pair.
Who cannot join
- Patient staying less than 48 hours in ICU
- Patient less than 24 hours on ventilator
- Patient not able to give an informed consent to participate in study or patient dies in ICU (both relative and patient are excluded).
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Regionshospitalet Herning
Herning, Central Jutland, 7400
Regionshospitalet Holstebro
Holstebro, Central Jutland, 7500
About this study
Official title: Dagbøger Til Kritisk Syge Patienter Skrevet af pårørende: Betydning for Patient og pårørende Samt Effekt i Forhold Til Udvikling af Symptomer på Posttraumatisk Stress
This study will investigate the effect of diaries written by relatives for critically ill patients on the risk of posttraumatic stress symptoms.
Utilizing a randomized controlled design pairs of one patient and one relative will be assigned to either diary intervention or standard care. The effect of the diary will be evaluated using a questionnaire 3 months post charge.
The results of this study will add to the body of knowledge on how diaries may help critical care survivors and their relatives to proceed with their lives.
Read the detailed description
Diaries written for critically ill patients has previously been shown to protect patient and relatives from new cases of post traumatic stress (Jones et al. 2010, Jones et al. 2012, Garrouste-Orgeas 2012). Furthermore it has been described how relatives and patients use diaries written by nurses to process the time they stayed in the intensive care unit (Egerod et al. 2011). This study will investigate if there is a similar effect, when relatives write the diary for the critically ill patient instead of nurses doing it as patients find it very valuable when relatives has contributed to the diary or when relatives presence has been documented in the diary (Engström et al. 2009).
The investigators hypothesis is that a diary written by relatives for critically ill patients will reduce the risk of developing symptoms of post traumatic stress in relatives and patients.
Design: randomized controlled study. Relative and patient are randomized as a pair to either intervention group (diary intervention) or control group (standard care). Relatives will be recruited to the study while the patient is critically ill in the ICU, the patient will be recruited when he or she is able to receive information about the study.
Intervention: Nurses guide the nearest relative (spouse, partner, child, parent or friend) to write a diary during the patients stay in the ICU and up to a month post discharge. The diary is a notebook which also contains a written instruction on how to write and use the diary during and after the time in the intensive care unit. At least two photographs of the patient is taken by the staff and added to the diary upon the patients consent.
Blinding: Due to the nature of the intervention neither caregivers nor participants can be blinded to the intervention. However, steps will be taken to ensure that the outcomes assessor is blinded.
Setting: the study will take place in the two ICUs (10 bed and 7 beds respectively) of the hospital unit Hospitalsenheden Vest, a 441 bed hospital serving 300.000 citizens. Both ICUs are mixed medical/surgical units.
Primary outcome: Risk of post traumatic stress symptoms (PTSS-14 (Twigg et al 2008).
Secondary outcomes: Anxiety and depressionsymptoms (HADS (Zigmond and Snaith 1983)) and general physical and psychological wellbeeing (SF-36 (Bjorner et al. 1998)).
Baseline data: To compare groups the following parameters will be recorded on all eligible patients. Patients: age, sex, education, marital status, diagnosis, SAPS-II score (Le Gall et al. 1993), hours on ventilator, LOS-ICU. Furthermore the following data will be recorded on participating relatives: age, sex, relation to patient, education and working status.
Sample size: Based on findings from a previous study (1) where the median PTSS-14 score was 24 (SD 12), alfa 5% and beta 80% and a minimal relevant difference of 4 points, 71 relative-patient pairs needs to be included in each group. To compensate for dropouts due to critical illness and death, 100 pairs will be included in each group. The data collection period is anticipated to last 24 months.
Follow-up: 3 months post ICU discharge all participants receive a questionnaire to be completed and returned by mail or email.
Statistical analysis will cover a comparison of mean and median values in the two study groups, supplemented by a stratified analysis to estimate risk reduction. Parametric and non-parametric test will be applied according to the nature of data.
Dissemination: Results, positive, negative or inconclusive will be published in an international peer-reviewed journal.
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- Being tested
- Diary
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaryOther
The intervention is a notebook in which the relative will be asked to keep a diary of the time when the patient is critically ill in the ICU. At least two photos of the patient will be added to the diary upon full consent from the patient.
The diary contains a written description on how to use the diary during and after the patients stay in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Relatives randomized to the intervention group is provied with a diary. Nurses advice relatives on how to write and use the diary under and after the patients stay in the ICU. A written description on how to use the diary is also provided.
At least two photographs of the patient is taken by nurses. Photographs will first be included in the diary when full consent from the patient has been obtained.
Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU. Receives: Other: Diary |
| Control group | No intervention | Standard Care. Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSS-14 (Post Traumatic Stress Symptoms)
14 items inventory covering all symptoms of PTSD.
Measured: 3 months post discharge from ICU
Secondary outcomes (2)
HADS (Hospital Anxiety and Depression Scale)
14 items inventory assessing symptoms of anxiety and depression.
Measured: 3 months post discharge from ICU
SF-36
36 items inventory covering the general physical and psychological wellbeing of an individual.
Measured: 3 months post discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start15 Mar 2015
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitalsenheden Vest
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Anne Højager Nielsen, Hospitalsenheden Vest
- Investigators
- Anne H Nielsen, RN, MCN, Principal investigator, Hospitalsenheden Vest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357680
- Sponsor's protocol ID
- 45129
- Status last verified
- Nov 2017
- First submitted
- 3 Feb 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
PubMed 20843344Jones C, Backman C, Griffiths RD. Intensive care diaries and relatives' symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May;21(3):172-6. doi: 10.4037/ajcc2012569.
PubMed 22549573Garrouste-Orgeas M, Coquet I, Perier A, Timsit JF, Pochard F, Lancrin F, Philippart F, Vesin A, Bruel C, Blel Y, Angeli S, Cousin N, Carlet J, Misset B. Impact of an intensive care unit diary on psychological distress in patients and relatives*. Crit Care Med. 2012 Jul;40(7):2033-40. doi: 10.1097/CCM.0b013e31824e1b43.
PubMed 22584757Egerod I, Christensen D, Schwartz-Nielsen KH, Agard AS. Constructing the illness narrative: a grounded theory exploring patients' and relatives' use of intensive care diaries. Crit Care Med. 2011 Aug;39(8):1922-8. doi: 10.1097/CCM.0b013e31821e89c8.
PubMed 21572330Engstrom A, Grip K, Hamren M. Experiences of intensive care unit diaries: 'touching a tender wound'. Nurs Crit Care. 2009 Mar-Apr;14(2):61-7. doi: 10.1111/j.1478-5153.2008.00312.x.
PubMed 19243522Twigg E, Humphris G, Jones C, Bramwell R, Griffiths RD. Use of a screening questionnaire for post-traumatic stress disorder (PTSD) on a sample of UK ICU patients. Acta Anaesthesiol Scand. 2008 Feb;52(2):202-8. doi: 10.1111/j.1399-6576.2007.01531.x. Epub 2007 Nov 14.
PubMed 18005373Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Bjorner JB, Kreiner S, Ware JE, Damsgaard MT, Bech P. Differential item functioning in the Danish translation of the SF-36. J Clin Epidemiol. 1998 Nov;51(11):1189-202. doi: 10.1016/s0895-4356(98)00111-5.
PubMed 9817137Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
PubMed 8254858Nielsen AH, Angel S, Egerod I, Hansen TB. The effect of diaries written by relatives for intensive care patients on posttraumatic stress (DRIP study): protocol for a randomized controlled trial and mixed methods study. BMC Nurs. 2018 Aug 16;17:37. doi: 10.1186/s12912-018-0306-y. eCollection 2018.
PubMed 30127664
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dagbøger Til Kritisk Syge Patienter Skrevet af pårørende: Betydning for Patient og pårørende Samt Effekt i Forhold Til Udvikling af Symptomer på Posttraumatisk Stress
- ClinicalTrials.gov ID
- NCT02357680
- Acronym / sponsor ID
- 45129
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Hospitalsenheden VestUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 6 Feb 2015 (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.
This study will investigate the effect of diaries written by relatives for critically ill patients on the risk of posttraumatic stress symptoms.
Utilizing a randomized controlled design pairs of one patient and one relative will be assigned to either diary intervention or standard care. The effect of the diary will be evaluated using a questionnaire 3 months post charge.
The results of this study will add to the body of knowledge on how diaries may help critical care survivors and their relatives to proceed with their lives.
Detailed description
Diaries written for critically ill patients has previously been shown to protect patient and relatives from new cases of post traumatic stress (Jones et al. 2010, Jones et al. 2012, Garrouste-Orgeas 2012). Furthermore it has been described how relatives and patients use diaries written by nurses to process the time they stayed in the intensive care unit (Egerod et al. 2011). This study will investigate if there is a similar effect, when relatives write the diary for the critically ill patient instead of nurses doing it as patients find it very valuable when relatives has contributed to the diary or when relatives presence has been documented in the diary (Engström et al. 2009).
The investigators hypothesis is that a diary written by relatives for critically ill patients will reduce the risk of developing symptoms of post traumatic stress in relatives and patients.
Design: randomized controlled study. Relative and patient are randomized as a pair to either intervention group (diary intervention) or control group (standard care). Relatives will be recruited to the study while the patient is critically ill in the ICU, the patient will be recruited when he or she is able to receive information about the study.
Intervention: Nurses guide the nearest relative (spouse, partner, child, parent or friend) to write a diary during the patients stay in the ICU and up to a month post discharge. The diary is a notebook which also contains a written instruction on how to write and use the diary during and after the time in the intensive care unit. At least two photographs of the patient is taken by the staff and added to the diary upon the patients consent.
Blinding: Due to the nature of the intervention neither caregivers nor participants can be blinded to the intervention. However, steps will be taken to ensure that the outcomes assessor is blinded.
Setting: the study will take place in the two ICUs (10 bed and 7 beds respectively) of the hospital unit Hospitalsenheden Vest, a 441 bed hospital serving 300.000 citizens. Both ICUs are mixed medical/surgical units.
Primary outcome: Risk of post traumatic stress symptoms (PTSS-14 (Twigg et al 2008).
Secondary outcomes: Anxiety and depressionsymptoms (HADS (Zigmond and Snaith 1983)) and general physical and psychological wellbeeing (SF-36 (Bjorner et al. 1998)).
Baseline data: To compare groups the following parameters will be recorded on all eligible patients. Patients: age, sex, education, marital status, diagnosis, SAPS-II score (Le Gall et al. 1993), hours on ventilator, LOS-ICU. Furthermore the following data will be recorded on participating relatives: age, sex, relation to patient, education and working status.
Sample size: Based on findings from a previous study (1) where the median PTSS-14 score was 24 (SD 12), alfa 5% and beta 80% and a minimal relevant difference of 4 points, 71 relative-patient pairs needs to be included in each group. To compensate for dropouts due to critical illness and death, 100 pairs will be included in each group. The data collection period is anticipated to last 24 months.
Follow-up: 3 months post ICU discharge all participants receive a questionnaire to be completed and returned by mail or email.
Statistical analysis will cover a comparison of mean and median values in the two study groups, supplemented by a stratified analysis to estimate risk reduction. Parametric and non-parametric test will be applied according to the nature of data.
Dissemination: Results, positive, negative or inconclusive will be published in an international peer-reviewed journal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: DiaryRelatives randomized to the intervention group is provied with a diary. Nurses advice relatives on how to write and use the diary under and after the patients stay in the ICU. A written description on how to use the diary is also provided. At least two photographs of the patient is taken by nurses. Photographs will first be included in the diary when full consent from the patient has been obtained. Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU. |
| Control group | No intervention | –Standard Care. Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Expected to stay in ICU > 48 hours
- Expected to be on ventilator > 24 hours
- Has a close relative > 18 years old
- Speaking and understanding Danish.
- Expected to be able to deliver an informed consent later
Key exclusion criteria (3 listed)
- Patient staying less than 48 hours in ICU
- Patient less than 24 hours on ventilator
- Patient not able to give an informed consent to participate in study or patient dies in ICU (both relative and patient are excluded).
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 |
|---|---|---|
| DiaryThe intervention is a notebook in which the relative will be asked to keep a diary of the time when the patient is critically ill in the ICU. At least two photos of the patient will be added to the diary upon full consent from the patient. The diary contains a written description on how to use the diary during and after the patients stay in the ICU. | Other | Intervention group |
Primary outcome
PTSS-14 (Post Traumatic Stress Symptoms)
Time frame: 3 months post discharge from ICU
14 items inventory covering all symptoms of PTSD.
2 secondary outcomes
HADS (Hospital Anxiety and Depression Scale)
Time frame: 3 months post discharge from ICU
SF-36
Time frame: 3 months post discharge from ICU
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 20 Nov 2017.
- Background: PubMed 20843344Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
- Background: PubMed 22549573Jones C, Backman C, Griffiths RD. Intensive care diaries and relatives' symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May;21(3):172-6. doi: 10.4037/ajcc2012569.
- Background: PubMed 22584757Garrouste-Orgeas M, Coquet I, Perier A, Timsit JF, Pochard F, Lancrin F, Philippart F, Vesin A, Bruel C, Blel Y, Angeli S, Cousin N, Carlet J, Misset B. Impact of an intensive care unit diary on psychological distress in patients and relatives*. Crit Care Med. 2012 Jul;40(7):2033-40. doi: 10.1097/CCM.0b013e31824e1b43.
- Background: PubMed 21572330Egerod I, Christensen D, Schwartz-Nielsen KH, Agard AS. Constructing the illness narrative: a grounded theory exploring patients' and relatives' use of intensive care diaries. Crit Care Med. 2011 Aug;39(8):1922-8. doi: 10.1097/CCM.0b013e31821e89c8.
- Background: PubMed 19243522Engstrom A, Grip K, Hamren M. Experiences of intensive care unit diaries: 'touching a tender wound'. Nurs Crit Care. 2009 Mar-Apr;14(2):61-7. doi: 10.1111/j.1478-5153.2008.00312.x.
- Background: PubMed 18005373Twigg E, Humphris G, Jones C, Bramwell R, Griffiths RD. Use of a screening questionnaire for post-traumatic stress disorder (PTSD) on a sample of UK ICU patients. Acta Anaesthesiol Scand. 2008 Feb;52(2):202-8. doi: 10.1111/j.1399-6576.2007.01531.x. Epub 2007 Nov 14.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 9817137Bjorner JB, Kreiner S, Ware JE, Damsgaard MT, Bech P. Differential item functioning in the Danish translation of the SF-36. J Clin Epidemiol. 1998 Nov;51(11):1189-202. doi: 10.1016/s0895-4356(98)00111-5.
- Background: PubMed 8254858Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
- Derived from this study: PubMed 30127664Nielsen AH, Angel S, Egerod I, Hansen TB. The effect of diaries written by relatives for intensive care patients on posttraumatic stress (DRIP study): protocol for a randomized controlled trial and mixed methods study. BMC Nurs. 2018 Aug 16;17:37. doi: 10.1186/s12912-018-0306-y. eCollection 2018.
Related trials for Stress Disorders, Post-Traumatic
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
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.
Anne H Nielsen, RN, MCN principal investigator
Hospitalsenheden Vest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diary in people with Stress Disorders, Post-Traumatic and Anxiety, run by Hospitalsenheden Vest at 2 sites in Denmark.
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 9 inclusion and 3 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
PTSS-14 (Post Traumatic Stress Symptoms) (time frame: 3 months post discharge from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02357680, which also lists 10 linked publications.
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 20 Nov 2017.