Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000606482
Ethics application status
Approved
Date submitted
22/11/2007
Date registered
26/11/2007
Date last updated
8/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Detailed Anchor Point Descriptors on Patient Self Report of Health-Related Quality of Life.
Scientific title
What is the effect of providing detailed upper and lower anchor point descriptors on patient self-report of health-related quality of life using the EQ-5D visual analogue scale amongst patients undergoing geriatric rehabilitation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This is a trial investigating a methodogical issue of measuring health-related quality of life. It will be conducted amongst subacute elderly hospital patients in the rehabilitation unit of a tertiary hosiptal. 2573 0
Condition category
Condition code
Public Health 2683 2683 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves two interventions:
Intervention A - providing detailed descriptors for the upper anchor point on a visual analogue scale of health-related quality of life (part of EQ-5D instrument). The duration of intervention A was the time taken to read the descriptors (less than 5 minutes).
Intervention B - providing detailed descriptors for the lower anchor point on a visual analogue scale of health-related quality of life (part of EQ-5D instrument). The duration of intervention B was the time taken to read the descriptors (less than 5 minutes).

The descriptors to be used in each intervention will be those descriptors used in another validated health-related quality of life measurement instrument, the AQoL (Assessment of Quality of Life).
Intervention code [1] 2308 0
Other interventions
Comparator / control treatment
A crossover design will compare the effect of giving the upper anchor point descriptor (intervention A) to the lower anchor point descriptor (intervention B). Comparisons will also be made to when no anchor points descriptors were given. There will essentially be no washout period between interventions (<5mins).
Control group
Active

Outcomes
Primary outcome [1] 3585 0
Patient self report of health-related quality of life using the visual analogue scale of the EQ-5D health-related quality of life instrument.
Timepoint [1] 3585 0
The EQ-5D visual analogue scale (VAS) of health state will be taken at three timepoints. After consent (1), immediately after the first intervention (2), then immediately after the second intervention (3). These will all be conducted within a 30 minute period.
Secondary outcome [1] 6007 0
Patients are asked whether the anchor desriptors, read to the patient as part of the intervention, described a more extreme health state than the anchor they had originally considerered (for the end of the visual analogue scale relating to the respective intervention) when completing the visual analogue scale at baseline, e.g. after Intervention A is given the participant is asked whether that description of best imaginable health was even better than they had considered to be the best imaginable health state at the top of the scale when they first rated their health on the VAS (at baseline). The patients response is recorded as binary data (y/n).
Timepoint [1] 6007 0
Immediately after each intervention.

Eligibility
Key inclusion criteria
1. Older hospital patients undergoing rehabilitation.
2. Basic cognition intact as indicated by a mini-mental state examination > 23.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to communicate effectively in English.

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)
The allocation sequence was generated by a blinded member of the research team and stored in a locked filing cabinet. Patients are approached by a research assistant who does not know the allocation sequence (or have access to the filing cabinet) who seeks informed consent. Consenting patients are assigned a participant number in order of recruitment. Consenting participants are then allocated to group (one or two) in order of their participant number to the next group in the random sequence by a separate research assistant who provides the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated via a computerised random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 496 0
4102

Funding & Sponsors
Funding source category [1] 2820 0
Hospital
Name [1] 2820 0
Princess Alexandra Hospital
Country [1] 2820 0
Australia
Primary sponsor type
Individual
Name
Steven McPhail
Address
Physiotherapy Department
Ground Floor
Bld 7
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 2545 0
Individual
Name [1] 2545 0
Dr. Terry Haines
Address [1] 2545 0
Physiotherapy Department
Ground Floor
Bld 7
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [1] 2545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4747 0
Princess Alexandra Hospital HREC
Ethics committee address [1] 4747 0
Ethics committee country [1] 4747 0
Australia
Date submitted for ethics approval [1] 4747 0
22/12/2005
Approval date [1] 4747 0
17/05/2006
Ethics approval number [1] 4747 0
2005/231
Ethics committee name [2] 4748 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 4748 0
Ethics committee country [2] 4748 0
Australia
Date submitted for ethics approval [2] 4748 0
18/12/2006
Approval date [2] 4748 0
17/01/2007
Ethics approval number [2] 4748 0
2007/037

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

Contacts
Principal investigator
Name 28206 0
Address 28206 0
Country 28206 0
Phone 28206 0
Fax 28206 0
Email 28206 0
Contact person for public queries
Name 11363 0
Steven McPhail
Address 11363 0
Physiotherapy Department
Ground Floor
Bld 7
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 11363 0
Australia
Phone 11363 0
+61 7 32406701
Fax 11363 0
Email 11363 0
[email protected]
Contact person for scientific queries
Name 2291 0
Steven McPhail
Address 2291 0
Physiotherapy Department
Ground Floor
Bld 7
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 2291 0
Australia
Phone 2291 0
+61 7 32406701
Fax 2291 0
Email 2291 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.