Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000735550
Ethics application status
Approved
Date submitted
13/06/2015
Date registered
16/07/2015
Date last updated
16/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of environmental cues for reducing post-traumatic amnesia following traumatic brain injury
Scientific title
The efficacy of environmental cues following traumatic brain injury compared to usual care for reducing time in post-traumatic amnesia.
Secondary ID [1] 286904 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 295319 0
Post-Traumatic Amnesia 295320 0
Condition category
Condition code
Neurological 295587 295587 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 295588 295588 0 0
Occupational therapy
Injuries and Accidents 295842 295842 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Environmental reorientation program which includes erecting a memory orientation board with a clock, automatic calendar (day of the week plus date), memory prompting posters, family education brochure (requesting families to re-orient patient) and a poster requesting consistent prompting from all healthcare staff and family members.

The duration of the intervention is 2 weeks. Occupational therapy staff will complete a daily check of the environment to monitor adherence to the environmental reorientation program.
Intervention code [1] 292089 0
Rehabilitation
Intervention code [2] 292259 0
Treatment: Other
Comparator / control treatment
Usual care: that is, daily assessment of post-traumatic amnesia (PTA) by an occupational therapist and reorientation of the patient by staff and family members as currently provided within the participating hospital.
Control group
Active

Outcomes
Primary outcome [1] 295298 0
Length post-traumatic amnesia (PTA) as determined by the Westmead PTA Scale.
Timepoint [1] 295298 0
From time of brain trauma to time of emergence from PTA
Secondary outcome [1] 315279 0
Memory as measured using the Rivermead Behavioural Memory Test
Timepoint [1] 315279 0
The outcome will be completed upon emergence from PTA and 3 months following emergence from PTA

Eligibility
Key inclusion criteria
*Participants must be admitted patients to the hospital site in which the research is undertaken.

*Participants must be aged between 18-65 years.

*Participants must be able to read in English for the purposes of being able to read the memory prompt posters.

*Participants must have sustained a traumatic brain injury (TBI), as defined by one or more of the following:
- Confusion or disorientation after the event
- Loss of Consciousness
- Glasgow Coma Scale Score <13

*Post Traumatic Amnesia (PTA) as measured by the Westmead PTA Scale score <12
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are documented to be in PTA for more than 48 hours prior to admission to Trauma Services because it is not possible to implement the environmental modifications in the Intensive Care Unit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2015
Actual
8/04/2015
Date of last participant enrolment
Anticipated
Actual
25/09/2015
Date of last data collection
Anticipated
Actual
25/03/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9835 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 291460 0
Charities/Societies/Foundations
Name [1] 291460 0
Royal Automobile Club (Victoria) Sir Edmund Herring Scholarship
Country [1] 291460 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road, Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 290140 0
Hospital
Name [1] 290140 0
Alfred Health
Address [1] 290140 0
55 Commercial Road, Melbourne, VIC 3004
Country [1] 290140 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293010 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 293010 0
55 Commercial Road, Melbourne, Vic 3004
Ethics committee country [1] 293010 0
Australia
Date submitted for ethics approval [1] 293010 0
Approval date [1] 293010 0
17/11/2014
Ethics approval number [1] 293010 0
534/14

Summary
Brief summary
Orientation interventions have been recommended as being important within cognitive rehabilitation (e.g. Corrigan et al, 1985) and researchers have also suggested that environmental stimuli which may aid in reorientation, such as familiar pictures or personal possessions (Watanabe et al, 1998). However critical evaluation of how effective these interventions are has been limited to date, with only controlled studies investigating the use of daily screening (Tate et al, 2000) and the use of calendars (Watanabe et al, 1998), and none of the studies have investigated this issue in acute care. This trial will test the efficacy of a standardised reorientation program that can be administered in acute care is developed to reduce the length of time a person remains in PTA after TBI
Trial website
Trial related presentations / publications
Manuscript under preparation.
Public notes

Contacts
Principal investigator
Name 58074 0
A/Prof Natasha Lannin
Address 58074 0
Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, VIC 3004
Country 58074 0
Australia
Phone 58074 0
+61 4 17135153
Fax 58074 0
Email 58074 0
[email protected]
Contact person for public queries
Name 58075 0
Natasha Lannin
Address 58075 0
Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, VIC 3004
Country 58075 0
Australia
Phone 58075 0
+61 4 17135153
Fax 58075 0
Email 58075 0
[email protected]
Contact person for scientific queries
Name 58076 0
Natasha Lannin
Address 58076 0
Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, VIC 3004
Country 58076 0
Australia
Phone 58076 0
+61 4 17135153
Fax 58076 0
Email 58076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIFeasibility of modifying the hospital environment to reduce the length of amnesia after traumatic brain injury: a pilot randomized controlled trial2021https://doi.org/10.1093/intqhc/mzab044
N.B. These documents automatically identified may not have been verified by the study sponsor.