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Trial registered on ANZCTR


Registration number
ACTRN12614001065684
Ethics application status
Approved
Date submitted
20/08/2014
Date registered
3/10/2014
Date last updated
3/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating use of the CommunicAid: Can access to a communication tool assist people with mild to moderate dementia to communicate their basic wants and needs and make decisions more effectively?
Scientific title
Can an assistive communication device (i.e. the CommunicAid App) assist participants with mild to moderate dementia living in a residential aged care facility to communicate their basic wants and needs more effectively?
Secondary ID [1] 285196 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 292805 0
Condition category
Condition code
Neurological 293099 293099 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with the CommunicAid Application on a tablet device. This is a communication aid that will assist the participant to make choices and convey their basic wants and needs (e.g. to select a drink or to request an item that they want). A family member will attend this initial session that is expected to last 90 minutes in duration. Participants will be introduced to the functions of the application and tablet device. The Tablet will be left with the participant to practice use with family and staff over a 5 week period. Individually tailored goals will be provided to each participant outlining when to use the device and how frequently (e.g. to use the device every morning tea time to request a drink). As such the frequency and duration will be clearly specified, but will vary across participants depending on their individual goals.
A pre- and post- assessment will be completed to measure communication outcomes following the five week trial. A post- treatment interview will be completed with staff and family to measure adherence to the intervention and use of the CommunicAid over the 5 week trial.
Intervention code [1] 290066 0
Rehabilitation
Intervention code [2] 290198 0
Treatment: Devices
Comparator / control treatment
A case series design will be used with each individual acting as their own control. There is no control or comparison group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292967 0
Communication Effectiveness Index: This will determine whether family / staff perceive improved communication effectiveness following the 5-week CommunicAid trial.
Timepoint [1] 292967 0
Post- intervention assessment (completed 1 week following the five-week CommunicAid trial)
Primary outcome [2] 292968 0
CommunicAid Observation Checklist: This will determine whether the participant is using the CommunicAid application more effectively and independently following the 5 week trial.
Timepoint [2] 292968 0
Post-intervention (1 week following the 5-week CommunicAid trial)
Secondary outcome [1] 310034 0
Exit Interview: Qualitative feedback will be collected from the participant, family and staff to determine whether any improvements in communication were perceived following the 5-week trial.
Timepoint [1] 310034 0
Post-intervention (completed 1 week following the 5-week CommunicAid trial)

Eligibility
Key inclusion criteria
1) Reported cognitive-communication difficulties and/or a diagnosis of mild to moderate dementia (e.g. MMSE 20 or above), (2) some ability to communicate and understand communication, (3) deemed able to see, hear and participate in the CommunicAid trial, (4) deemed able to give informed consent by treating doctor, and (5) a willing caregiver (family or staff) to also participate in the study.
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Deemed unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Five residents with a diagnosis of early stage or mild dementia at Bethanie Group Inc will be invited to participate in this study. Staff and family members that routinely visit and work with these residents will also be invited to participate in the study.
A nurse manager at each facility, in consultation with the residents’ GP or medical specialist, will identify residents that are eligible to participate in the study. This will include residents that are deemed able to give informed consent to participate based on recent cognitive test results and current level of function and participation. Eligible participants will be invited to participate and provided with an information sheet. The opportunity to ask questions about the study and to discuss it with a family member will be provided. Written informed consent will be obtained prior to enrolment in the study or release of personal details to the research team.
The nurse manager will also be responsible for inviting staff and family members associated with the 5 residents to take part in the study. They will be provided with an information sheet and written informed consent will be obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Case series design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a descriptive, phase 1 study using qualitative methodologies. Interviews will be transcribed verbatim and analysed thematically using content analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
8/09/2014
Date of last participant enrolment
Anticipated
26/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289813 0
University
Name [1] 289813 0
Curtin University
Country [1] 289813 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth
Western Australia 6102
Country
Australia
Secondary sponsor category [1] 288504 0
None
Name [1] 288504 0
N/A
Address [1] 288504 0
N/A
Country [1] 288504 0
Other collaborator category [1] 278112 0
Charities/Societies/Foundations
Name [1] 278112 0
Alzheimer's WA
Address [1] 278112 0
9 Bedbrook Pl, Shenton Park WA 6008
Country [1] 278112 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291544 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 291544 0
Kent Street, Bentley, Perth
Western Australia 6102
Ethics committee country [1] 291544 0
Australia
Date submitted for ethics approval [1] 291544 0
07/07/2014
Approval date [1] 291544 0
22/08/2014
Ethics approval number [1] 291544 0
HR165/2014

Summary
Brief summary
The proposed proof of concept study aims to identify factors that influence successful use of the CommunicAid App within a residential aged care setting. Using a case series design the study aims to create five in-depth case profiles of CommunicAid App use, characterising individual client factors (e.g. communication profile, previous use of technology) and environmental factors (e.g. communication opportunities, available communication support, lighting and noise levels within the facility). Systematic analysis and interpretation of the individual case profiles will allow the critical factors to be identified that influence successful use of the App during everyday interactions. This will provide direction for the development of tailored training and communication support strategies to embed use of the App into routine care delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50810 0
Ms Jade Cartwright
Address 50810 0
Curtin University
Kent Street, Bentley, Perth
Western Australia 6102
Country 50810 0
Australia
Phone 50810 0
+61892663039
Fax 50810 0
Email 50810 0
[email protected]
Contact person for public queries
Name 50811 0
Jade Cartwright
Address 50811 0
Curtin University
Kent Street, Bentley, Perth
Western Australia 6102
Country 50811 0
Australia
Phone 50811 0
+61892663039
Fax 50811 0
Email 50811 0
[email protected]
Contact person for scientific queries
Name 50812 0
Jade Cartwright
Address 50812 0
Curtin University
Kent Street, Bentley, Perth
Western Australia 6102
Country 50812 0
Australia
Phone 50812 0
+61892663039
Fax 50812 0
Email 50812 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.