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Trial registered on ANZCTR


Registration number
ACTRN12611000974909
Ethics application status
Approved
Date submitted
8/09/2011
Date registered
12/09/2011
Date last updated
12/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing Cognitive Function in the Elderly Through Telemedicine.
Scientific title
Assessing cognitive function via video conferencing for referred elderly patients at memory disorder clinics for agreement in relation to the diagnosis of dementia.
Secondary ID [1] 263006 0
NHMRC Project Grant: 456135
Universal Trial Number (UTN)
U1111-1124-4300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diagnosis of Dementia via Video Conferencing 270736 0
Condition category
Condition code
Neurological 270913 270913 0 0
Dementias
Mental Health 270933 270933 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aimed to identify the validity of the diagnosis of dementia via Videoconference (VC).
All patients were assessed independently by two specialist physicians. They were allocated one face-to-face (FTF) assessment (Standard Clinical Practice) and an additional assessment (a VC assessment) on the same day. The order of assessment, both doctor and format, was randomized. Each physician had access to the patient chart and the results of a battery of standardised cognitive assessments administered FTF by the clinic nurse.
For VC assessment, the patient was shown to a clinic room by the nurse and introduced to the specialist physician via video. All paired assessments occurred on the same day. The protocol excluded any physical examination for both study arms, other than observation of gait and other evident physical features.
Patients’ cognitive function was defined in accordance with the DSM-IV diagnosis of dementia (290.0-294.8), by the following three mutually exclusive options: ‘Normal cognitive function’ (No evidence of impairment meeting any of the criteria related to DSM-IV cognitive disorder); ‘Cognitive impairment no dementia’ (Evidence of impairment meeting some, but not all, DSM-IV criteria for dementia, including amnestic disorder and cognitive impairment not otherwise specified ); or ‘Dementia meeting DSM-IV criteria’ (all criteria meet).
No specific time limit is stipulated for the assessments, but the assessment process is to be carried out during usual clinic days so in general the assessment (eithe face-to-face or via video conference), should be approimately 60 minutes.
All assessments are to occur on the same day (with no minimum, maximum number of hours between assessments). If the second assessment can not be completed on the same day the patient is then excluded.
Intervention code [1] 269354 0
Diagnosis / Prognosis
Comparator / control treatment
All patients were assessed independently by two specialist physicians. They were allocated one FTF assessment (Standard Clinical Practice) and an additional assessment (a second face to face assessment) on the same day. The order of assessment, both doctor and format, was randomized.
Control group
Active

Outcomes
Primary outcome [1] 279583 0
The outcome of interest was the difference in percentage agreement (Po) between paired assessments of the video arm (VC thenFTF (VF)/FTF then VC (FV)) and the standard clinical practice arm (FTF then FTF (FF)), for the question: Does the patient have dementia? scored as -Normal Cognition(0); Cognitive Impairment not meeting DSMIV Criteria for dementia(1); and Yes, Meeting DSM-IV Criteria for dementia(2). A non-inferiority study tests whether the percentage agreement between clinicians in an intervention arm (FV/VF) does not lie beyond the lower limit of an acceptable range (a one-tailed area of clinical indifference) when compared with the standard clinical practice arm (FF).
Timepoint [1] 279583 0
At time of assessment.
Secondary outcome [1] 287954 0
Agreement of classification of diagnostic sub-type. After the doctor has identified the presence or absence of dementia, they are asked to identify the sub-type of dementia, if dementia was present. For example, was it Alzheimer's Dementia, or vascular dementia, etc. This is especially challenging at a first assessment as more information may be required before a formal diagnosis including diagnositic sub-type can be made.
Timepoint [1] 287954 0
At time of assessment.
Secondary outcome [2] 287955 0
Identification of further investigative or management options (such as additional investigations, medication recommendations or allied health referral). This information was identified through the recommendations or referrals indicated as necessary on the data colleciton sheet by each doctor at the conclusion of the assessment.
Timepoint [2] 287955 0
At time of assessment.
Secondary outcome [3] 287956 0
The contribution of physical examination to the diagnosis of dementia via VC. following the initial assessment and the completion of the data collection form, one doctor was asked to complete a physical examination of the patient. this occurred in person. the doctor was then asked to complete a second data collection form answering the same questions as previously (diagnosis, type). They were also asked to indicate if there were any changes to the diagnosis, investigations or management of the patient in relation to matters of cognition, and non-cognitive issues.
Timepoint [3] 287956 0
At time of assessment.

Eligibility
Key inclusion criteria
Patients referred by GP for assessment of cognition at a Memory Disorder Clinic.
Patients over the age of 50.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients previously seen by either specialist at the Memory Disorder Clinic.
No consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The activities for the day at the memory clinic were described to the patient and the carer. They were provided with a verbal explanation of the study and given written material. Patient and carer were given time to talk privately about the study. They were then asked if they would like to participate. Written consent was obtained from the patient or the carer. They were advised that they could withdraw at any time during the day.
After consent, a numbered sealed opaque envelope was opened and the patient was allocated to format of interview and which doctor would see the patient based on the random number allocation in the envelope. Doctors were then informed who they were to assess and the format of interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was carried out using a balanced block randomisation code which was generated by a qualified statistician (EB) using an electronic random number generator, stratified according to study arm (Standard Clinical Practice; Video), order of interview format (FTF or VC first), order of physician assessment (Physician 1, Physician 2 for first or second interview) and blocked (N=8) according to clinic site; assignments were concealed in opaque, sealed envelopes that were numbered consecutively within each stratum.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4469 0
4102
Recruitment postcode(s) [2] 4470 0
4029
Recruitment postcode(s) [3] 4471 0
6913
Recruitment postcode(s) [4] 4472 0
6982

Funding & Sponsors
Funding source category [1] 269815 0
Government body
Name [1] 269815 0
National Health and Medical Research Council
Country [1] 269815 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 268847 0
University
Name [1] 268847 0
The Centre for Research in Geriatric Medicine, The University of Queensland
Address [1] 268847 0
CRGM
Level 2, Building 33
The Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [1] 268847 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271780 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 271780 0
Ethics committee country [1] 271780 0
Australia
Date submitted for ethics approval [1] 271780 0
Approval date [1] 271780 0
15/11/2006
Ethics approval number [1] 271780 0
2006000833

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

Contacts
Principal investigator
Name 33132 0
Address 33132 0
Country 33132 0
Phone 33132 0
Fax 33132 0
Email 33132 0
Contact person for public queries
Name 16379 0
Melinda Martin-Khan
Address 16379 0
The Centre for Research in Geriatric Medicine
Level 2, Building 33
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 16379 0
Australia
Phone 16379 0
61731765530
Fax 16379 0
Email 16379 0
[email protected]
Contact person for scientific queries
Name 7307 0
Melinda Martin-Khan
Address 7307 0
The Centre for Research in Geriatric Medicine
Level 2, Building 33
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 7307 0
Australia
Phone 7307 0
61731765530
Fax 7307 0
Email 7307 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

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