Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001350718
Ethics application status
Approved
Date submitted
2/12/2013
Date registered
10/12/2013
Date last updated
10/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of Skype (Trademark) family conversations compared to regular telephone calls to reduce agitation in nursing home residents with dementia.
Scientific title
The use of Skype (Trademark) family conversations compared to regular telephone calls to reduce agitation in nursing home residents with dementia.
Secondary ID [1] 283677 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe dementia 290635 0
Condition category
Condition code
Neurological 291021 291021 0 0
Dementias
Mental Health 291067 291067 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A research assistant will initiate Skype contact via an iPad between the aged care facility resident and their relative or carer twice per week for 2 weeks. The relatives or carers are asked that the call duration be no longer than 20 minutes however it is at the discretion of the resident and their relative or carer if the call is of a shorter duration. For consistency, the same relative or carer is required to particpate for the duration of the interventions. There is a wash-out period of at least one week between treatments.
Intervention code [1] 288376 0
Behaviour
Comparator / control treatment
A research assistant will initiate telephone contact between the aged care facility resident and their relative or carer twice per week for 2 weeks. The relatives or carers are asked that the call duration be no longer than 20 minutes however it is at the discretion of the resident and their relative or carer if the call is of a shorter duration. For consistency, the same relative or carer is required to particpate for the duration of the interventions.
Control group
Active

Outcomes
Primary outcome [1] 291009 0
One physical or verbally agitated behaviour will be recorded as being present or absent during 30 second intervals over a 60 minute period. The Cohen Mansfield Agitation Inventory (CMAI) is used the establish the target behaviour to be observed. The measure is conducted with nursing staff familiar with the resident's behaviours and assesses the frequency and type of agitated behaviours.
Timepoint [1] 291009 0
Observations commence 20 minutes prior to intervention and depending on the length of the intervention period, observations continue for at least 20 minutes post intervention.
Secondary outcome [1] 305818 0
Affect. A modified version of Positive and Negative Affect Schedule is used to assess affect. The types of affect cover various emotions (Including: Pleasure, Contentment, Anger, Fear or Anxiety, Sadness) and Neutral affect. The observer records the predominant affect within each 30 second interval.
Timepoint [1] 305818 0
Observations commence 20 minutes prior to intervention and depending on the length of the intervention period, observations continue for at lest 20 minutes post intervention. For each 30 second interval the predominant type of affect is recorded. The overall duration is 60 minutes.
Secondary outcome [2] 305819 0
Type of Engagement. The study distinguishes between 4 types of defined engagement based on the Menorah Park Engagement Scale: non-engagement, self-engagement, passive engagement and active engagement.
Timepoint [2] 305819 0
Observations commence 20 minutes prior to intervention and and depending on the length of the intervention period, observations continue for at lest 20 minutes post intervention. For each 30 second interval the predominant type of engagement is recorded (i.e. Active, Passive, Non Engagement and/or Self Engagement). The overall duration of the observations is 60 minutes.

Eligibility
Key inclusion criteria
A participant needs to be in the aged care facility for at least 3 months, have a history of dementia and be stable re: medical, psychological and medication regime. Also the agitated behaviours should occur several times an hour on a daily basis and are not associated with nursing activities (i.e. ADLs). The behaviours are also not due to pain, physical illness, depression or psychosis
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of an acutely life threatening illness. The agitated behaviours are potentially dangerous to researchers.

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)
We use an efficient, economical design with random (non-concealed) allocation, to treatment or control conditions followed by a crossover
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation is generated via Excel
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
1/08/2012
Actual
1/08/2012
Date of last participant enrolment
Anticipated
1/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288362 0
Other Collaborative groups
Name [1] 288362 0
Dementia Collaborative Research Centre
Country [1] 288362 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Dementia Collaborative Research Centre
Address
School of Psychiatry,
Faculty of Medicine
Level 3, AGSM Building
University of New South Wales
SYDNEY
NSW 2052
Country
Australia
Secondary sponsor category [1] 287069 0
None
Name [1] 287069 0
Address [1] 287069 0
Country [1] 287069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290242 0
Southern Health Human Research Ethics Conmittee
Ethics committee address [1] 290242 0
Ethics committee country [1] 290242 0
Australia
Date submitted for ethics approval [1] 290242 0
Approval date [1] 290242 0
30/05/2012
Ethics approval number [1] 290242 0
12094B

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

Contacts
Principal investigator
Name 44666 0
Prof Daniel O'Connor
Address 44666 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham Victoria
3192
Country 44666 0
Australia
Phone 44666 0
613 9265 1700
Fax 44666 0
613 9265 1711
Email 44666 0
[email protected]
Contact person for public queries
Name 44667 0
Barbara Eppingstall
Address 44667 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham Victoria
3192
Country 44667 0
Australia
Phone 44667 0
613 9265 1706
Fax 44667 0
613 9265 1711
Email 44667 0
[email protected]
Contact person for scientific queries
Name 44668 0
Daniel O'Connor
Address 44668 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham Victoria
3192
Country 44668 0
Australia
Phone 44668 0
613 9265 1700
Fax 44668 0
613 9265 1711
Email 44668 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.