Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000569303
Ethics application status
Approved
Date submitted
13/04/2017
Date registered
24/04/2017
Date last updated
24/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the role of a diary in new onset stress,anxiety, depression and post traumatic stress disorder in relatives of patients in the intensive care unit
Scientific title

Psychological support for relatives of patients in the intensive care unit using diaries- an exploratory study
Secondary ID [1] 291694 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic Stress Disorder ( PTSD) 302864 0
Stress 302866 0
ANXIETY 302959 0
Condition category
Condition code
Mental Health 302427 302427 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family members of 100 consecutive patients admitted to the Royal Adelaide Hospital
Intensive Care Unit and remaining in the unit for 48hrs or more will be identified.
On day 3 of admission family members will be approached by the research team and asked to identify a primary next of kin or decision maker. This person will then be approached to participate in the study.The study will be explained to them and they will be asked if they consent to participate.

The diary is a free flowing manuscript that portrays the patient’s journey in a critical care environment. It has headings/ templates to be completed, and contains key points for the person writing in it. This is included under the title ‘this is me” and gives an opportunity for us to know the patient better. By divulging all possible information about the patient, we believe the relative is likely to be less stressed and this will hopefully impact on the incidence of PTSD. The diary does have a preamble and includes guidelines on how each entry should be written.

The family members were given the opportunity to contribute to the diary with photographs, testimonials and vignettes. Medical input was limited unless specifically requested by the patient’s relative. The diary was identified as “complete” only if it had an entry on every day of their ICU stay either by the family member or by the nurse. Family members were given an opportunity to document in the diary retrospectively, if they were unable to be present on a particular day.

During their stay in the ICU, the family members were encouraged to express their feelings in writing in the diary. At the time of discharge from the ICU, the diary was hand-delivered.by the Investigator to the designated family member. Family members who chose not to fill in diaries were compared to those who had. At 90 days post discharge of the patient from ICU, all the participants were telephoned to go through the IES-R and DASS21 questionnaires again.
A separate consent form will be provided. There will be a declination form given to the
consenting next of kin at the time of obtaining consent to give them the opportunity to
withdraw consent if their circumstances change. Even before the commencement of the
telephonic interview the interviewer will ask for a verbal consent before proceeding with
the questionnaire. In the event of the next of kin disagreeing to participate in the
interview, the interview will be abandoned.
Intervention code [1] 297781 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301766 0
The primary outcome of this pragmatic study was to explore the feasibility of recruitment, assessed by review of study records to determine the proportion of eligible participants who complete the diary
Timepoint [1] 301766 0
11 months since commencement of the trial
Primary outcome [2] 301801 0
Impact on depression assessed using DASS-21 scoring system
Timepoint [2] 301801 0
90 days post discharge from the ICU
Primary outcome [3] 301832 0
Impact on anxiety assessed using DASS-21 scoring system
Timepoint [3] 301832 0
90 days post discharge from ICU
Secondary outcome [1] 333799 0
The secondary outcome of the study were to ascertain if there was an association between provision of an ICU diary and PTSD symptoms as defined by an Impact of Event Scales-Revised ( IES-R SCORE of >33) .
This information would then provide us a baseline profile for future hypothesis testing on its impact
Timepoint [1] 333799 0
90 days post discharge

Eligibility
Key inclusion criteria
1) Inclusion criteria:
A relative who has been designated as the official next of kin for the patient and is aged > 18 years of age
Expected stay of the patient in the RAH ICU >48h
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
2)Exclusion criteria:
No identifiable relative or next of kin for the patient

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Statistical analysis
Statistical analyses were performed using SAS Version 9.3 (SAS Institute Inc., Cary, NC, USA). Continuous variables such as age, APACHE III and Injury Severity Scale were generally not normally distributed and were therefore described by median and interquartile range. A Fisher’s exact test or a chi-square test was used to assess the association between survival and categorical variables. Wilcoxon rank sum tests were used to assess the association between survival and continuous variables. These tests were also used to assess the association of the presence/absence of intervention with other variables. p <0.05 was considered significant. Logistic generalised estimating equations (GEE) models were used to get the average population values with adjustment for repeated measures, whilst testing the association between presence of PTSD and time period (controlling for completeness of diaries).
A logistic regression was performed to see how PTSD at follow-up (IES_R>33) is associated with useful completion of the diary, controlling for PTSD at baseline.
Univariate logistic regression was performed with the outcomes of intervention and survival versus various continuous predictors; results are reported as odds ratio (OR) and 95% confidence intervals. Univariate linear regression was used to investigate the association between IESR at 3 months and various predictors, adjusting baseline IESR Stress at 3 months was also investigated in this manner,

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
25/05/2016
Date of last data collection
Anticipated
Actual
24/08/2016
Sample size
Target
100
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7843 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 15783 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296193 0
Hospital
Name [1] 296193 0
Royal Adelaide Hospital
Country [1] 296193 0
Australia
Primary sponsor type
Individual
Name
Dr KRISHNASWAMY SUNDARARAJAN
Address
Intensive Care Unit, Level 4,

Robert Gerard Wing, Royal Adelaide Hospital

NORTH TERRACE

Adelaide. South Australia 5000
Country
Australia
Secondary sponsor category [1] 295104 0
None
Name [1] 295104 0
Address [1] 295104 0
Country [1] 295104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297434 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 297434 0
Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 297434 0
Australia
Date submitted for ethics approval [1] 297434 0
26/02/2015
Approval date [1] 297434 0
25/05/2015
Ethics approval number [1] 297434 0
HREC reference number: HREC/15/RAH/48 RAH Protocol No: 150216

Summary
Brief summary
The primary aim of this pragmatic study was to explore the role of an intensive care diary in the ICU, particularly with reference to the logistics of recruitment, potential acceptance of diaries amongst our patient population and it’s impact on anxiety, stress and depression. The secondary aims of the study were to ascertain if there was an association between provision of an ICU diary and PTSD symptoms which could then provide baseline profile for future hypothesis testing on its impact

Ethical approval for this study was obtained from the Royal Adelaide Hospital Human Research Ethics Committee

HREC reference number: HREC/15/RAH/48

RAH Protocol No: 150216
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74026 0
Dr Krishnaswamy Sundararajan
Address 74026 0
Dr Krishnaswamy Sundararajan
Deputy Director, Intensive Care Unit, Royal Adelaide Hospital
Level 4, ICU, Robert Gerard Wing, Royal Adelaide Hospital
North terrace
Adelaide. South Australia 5000
Country 74026 0
Australia
Phone 74026 0
+61 8 82220038
Fax 74026 0
Email 74026 0
[email protected]
Contact person for public queries
Name 74027 0
Dr Krishnaswamy Sundararajan
Address 74027 0
Dr Krishnaswamy Sundararajan
Deputy Director, Intensive Care Unit, Royal Adelaide Hospital
Level 4, ICU, Robert Gerard Wing, Royal Adelaide Hospital
North Terrace
Adelaide. South Australia 5000
Country 74027 0
Australia
Phone 74027 0
+61 8 82220038
Fax 74027 0
Email 74027 0
[email protected]
Contact person for scientific queries
Name 74028 0
Dr Krishnaswamy Sundararajan
Address 74028 0
Dr Krishnaswamy Sundararajan
Senior Clinical Lecturer, Discipline of Acute Care Medicine, University of Adelaide
Level 4, ICU, Robert Gerard Wing, RAH
North Terrace
Adelaide. South Australia 5000
Country 74028 0
Australia
Phone 74028 0
+61 8 82220038
Fax 74028 0
Email 74028 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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