Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000097549
Ethics application status
Approved
Date submitted
7/03/2006
Date registered
13/03/2006
Date last updated
13/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study to Investigate Whether Visual Cues Assist the Elderly to Understand Imaginary Falls Scenarios.
Scientific title
A Pilot Study to Investigate Whether Visual Cues Assist the Elderly to Understand Imaginary Falls Scenarios.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly Rehabilitation Inpatients admitted due to any medical condition 1061 0
Condition category
Condition code
Physical Medicine / Rehabilitation 1141 1141 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Visual cues to accompany survey questions. The intervention group will receive visual cues to accompany a survey involving questions about falls rates, imaginary falls scenarios of varying severities and willingness to pay for falls prevention questions. The duration of the intervention is the time taken to complete the survey. Each participant will complete the survey once only. We currently estimate that time taken to complete the survey will take approximately 90 minutes with no visual cues and perhaps 10 minutes less with visual cues.
Intervention code [1] 930 0
None
Comparator / control treatment
The control group will complete the same survey but will not have visual cues to assist.
Control group
Active

Outcomes
Primary outcome [1] 1534 0
Patient recall and understanding of questions.
Timepoint [1] 1534 0
Measured after each scenario/question. Once the patient has answered each question they will be asked to recall key points about the scenario/question to demonstrate understanding.
Secondary outcome [1] 2771 0
Time taken to complete survey.
The time taken to complete each section of the survey interview will be recorded during the interview and later analysed. If the intervention is effective it is likely to reduce the time taken to complete each section of the survey.
Timepoint [1] 2771 0

Eligibility
Key inclusion criteria
Consenting patients on rehabilitation wards.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive Deficit, inability to verbally communicate effectively in English (eg. aphasic stroke patient).

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1246 0
Self funded/Unfunded
Name [1] 1246 0
Physiotherapy Department, Princess Alexandra Hospital
Country [1] 1246 0
Australia
Primary sponsor type
Individual
Name
Steven McPhail
Address
Country
Secondary sponsor category [1] 1101 0
Individual
Name [1] 1101 0
Terrence Haines
Address [1] 1101 0
Country [1] 1101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2580 0
Princess Alexandra Hospital
Ethics committee address [1] 2580 0
Ethics committee country [1] 2580 0
Australia
Date submitted for ethics approval [1] 2580 0
Approval date [1] 2580 0
23/01/2006
Ethics approval number [1] 2580 0
2005/194

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35503 0
Address 35503 0
Country 35503 0
Phone 35503 0
Fax 35503 0
Email 35503 0
Contact person for public queries
Name 10119 0
Steven McPhail
Address 10119 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woollongabba QLD 4102
Country 10119 0
Australia
Phone 10119 0
+61 7 32402120
Fax 10119 0
Email 10119 0
[email protected]
Contact person for scientific queries
Name 1047 0
Steven McPhail
Address 1047 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woollongabba QLD 4102
Country 1047 0
Australia
Phone 1047 0
+61 7 32402120
Fax 1047 0
Email 1047 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
No additional documents have been identified.