NCT02357680

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

2.6 years

First QC Date

February 3, 2015

Last Update Submit

November 17, 2017

Conditions

Stress Disorders, Post-TraumaticAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • PTSS-14 (Post Traumatic Stress Symptoms)

    14 items inventory covering all symptoms of PTSD.

    3 months post discharge from ICU

Secondary Outcomes (2)

  • HADS (Hospital Anxiety and Depression Scale)

    3 months post discharge from ICU

  • SF-36

    3 months post discharge from ICU

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Relative:
  • \*Speaking and understanding Danish
  • Relative and patient are included in the study as a pair.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regionshospitalet Herning

Herning, Central Jutland, 7400, Denmark

Location

Regionshospitalet Holstebro

Holstebro, Central Jutland, 7500, Denmark

Location

Related Publications (10)

  • 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.

    PMID: 20843344BACKGROUND

  • Jones 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.

    PMID: 22549573BACKGROUND

  • Garrouste-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.

    PMID: 22584757BACKGROUND

  • Egerod 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.

    PMID: 21572330BACKGROUND

  • Engstrom 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.

    PMID: 19243522BACKGROUND

  • Twigg 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.

    PMID: 18005373BACKGROUND

  • Zigmond 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.

    PMID: 6880820BACKGROUND

  • Bjorner 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.

    PMID: 9817137BACKGROUND

  • Le 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.

    PMID: 8254858BACKGROUND

  • Nielsen 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.

    PMID: 30127664DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Anne H Nielsen, RN, MCN

    Hospitalsenheden Vest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MCN, ph.d. student

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

March 15, 2015

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

DK(2)