Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000898651
Ethics application status
Approved
Date submitted
31/07/2023
Date registered
22/08/2023
Date last updated
22/08/2023
Date data sharing statement initially provided
22/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and pilot randomised controlled trial of a co-designed home-based personalised reablement strategy program delivered via Voice-Controlled Intelligent Personal Assistants in older adults aged 60-89 years with mild cognitive impairment and/or dementia.
Scientific title
Feasibility and pilot randomised controlled trial of a co-designed home-based personalised reablement strategy program delivered via Voice-Controlled Intelligent Personal Assistants in older adults aged 60-89 years with mild cognitive impairment and/or dementia.
Secondary ID [1] 309383 0
Nil known
Universal Trial Number (UTN)
Trial acronym
VOICE-COG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 329608 0
Mild cognitive impairment 329609 0
Condition category
Condition code
Neurological 326535 326535 0 0
Dementias
Mental Health 327914 327914 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes a 12-week feasibility and pilot randomised controlled trial of a co-designed home-based personalised reablement strategy program delivered via Voice-Controlled Intelligent Personal Assistants (VIPAs) in older adults aged 60 to 89 years with mild cognitive impairment (MCI) and/or dementia.

We used participatory research methods to co-design the home-based personalised reablement strategy program delivered by VIPA with end-users (people with dementia/MCI aged 60 to 89 years and their carers) and stakeholders (health professionals that included psychologists, general practioners, occupational therapists and nurses.). ~Three co-design workshops (~one hour each, 1 per phase) was conducted to identify intervention content, functionality, and features for the VIPA. These workshops were focused on ‘design-thinking’ and coming to a consensus regarding the most appropriate and useful features to be included in a home-based personalised reablement strategy program delivered by VIPA. The workshops were conducted online via Zoom.

VIPA intervention participants will receive, via courier, a pre-registered Amazon Alexa Echo Show 8 VIPA and will also be provided with instructions for them and/or their carer on connecting the device to their home WiFi, with additional support from an investigator if required. They will also receive access to our client facing Alexa software “My Training Buddy” to receive their personalised reablement strategy program. Using a person-centred approach to care, participants and carers will complete a 30-minute video conference consult with a clinical psychologist to capture clinical history, personal barriers/goals, and collaboratively develop two personally meaningful goals from the seven goals listed below, in relation to improving cognition, function and/or activities of daily living delivered by VIPA from the findings of our co design workshops below.
1) Routine Reminders: To support participants manage their daily routine, the VIPA will provide audio and visual prompts for self-care activities at pre-selected times throughout the day. Self-care activities will be personalised but can include fluid, meals and snack intake and medication. The VIPA will ask if these activities have been completed and participants will use natural voice to respond. The carer will be notified of negative responses. Barriers to achieving these daily self-care activities will be identified during the initial goal-setting interview and personalised solutions offered by the VIPA. These will include the location of medication or suggestions for meal or snack foods.
2) Mood Monitor: To better cope with the anxiety and stress associated with dementia/MCI, the VIPA will “check-in” with participants at pre-agreed time each day. The VIPA will ask participants how they are feeling and suggest different activities depending on their response. These activities will include breathing and meditation exercises, listening to nature sounds, playing pre-selected music play-lists, or listening to a joke. The VIPA will send a notification of low mood.
3) Family and Friends Facilitator: The VIPA will remind participants to stay connected to family and friends by offering three activities. The first activity will prompt participants to contact a family member or friend on a pre-selected day and time each week. The carer and participant will provide family and friends’ details which will be saved to the Alexa App enabling participants to make voice-activated video calls or mobile calls by using the family or friend member’s name. Audio and text prompts will remind participants who to contact, their relationship to that person, and any other important information such as names of grandchildren. The VIPA will ask participants to confirm if they have contacted that person enabling additional reminders if the participant hasn’t contacted that person for several weeks. The second activity will be reminder prompts for the Alexa to show the participant online photo albums of family and/or friends. Participants can provide text descriptions that will be added to photos before uploading to the Amazon Photos app. Finally, each week, the carer and participant will be prompted to complete an online form responding to questions about their past experiences such as childhood, marriage, children, holidays. Participants will be prompted to upload relevant photos from family events such as weddings, birthdays, or holidays. This information will be used to create a Life Story slideshow movie for the participant to be uploaded to the Buddy link skill. The VIPA will prompt the participant weekly to ask if they would like to watch their Life Story movie.
4) Kitchen Helper: The VIPA will ask the participant on a pre-agreed day and time if they would like to bake or cook a recipe. Carers and participants will be asked to complete an online form each week with a personal recipe, that will be uploaded to the buddy link skill. The VIPA will then broadcast the participant’s recipe, step by step, using audio, text, and images. Participants can use their voice to ask Alexa to go back, repeat, or go to the next step of their recipe.
5) Activities and Appointments Assistant: To facilitate planning and attendance of activities and appointments, carers and participants will complete an online form of weekly appointments. This data will be uploaded into Alexa functions including calendar, reminders, and checklists. Each morning the Buddy link skill on the VIPA will broadcast instructions using audio, text, and video to remind participants how to use this Alexa functionality. The VIPA will use audio and text to announce the participant’s calendar appointments every morning, providing two personalised reminders when it’s time to get ready and when it’s time to leave the house. For recurring weekly appointments, participants there will be an audio and text checklist reminder of what to take with them when they leave the house.
6) Household Manager: The VIPA will remind participants, on a pre-agreed day/time, to complete pre-selected household tasks, such as doing the laundry or unloading the dishwasher. The VIPA will support participants in completing these tasks by using personalised audio, text, and images prompts, with instructions on what to do, where to locate items, and the importance of the activity.
7) Active Minds Adviser: The VIPA will ask participants at a pre-agreed time each day if they would like to engage in one of four cognitively and emotionally stimulating activities. These include 1) watching updates from their preferred news channel; 2) listening to a pre-selected audiobook; 3) listening to a podcast related to a meaningful activity or hobby such as gardening; 4) watching short engaging documentary videos according to the participant’s personal preference, such as art, history, travel or wildlife.

Participants’ perceptions of effectiveness will be measured using the practical dementia-specific model of using Goal Attainment Scaling (GAS) to measure meaningful outcomes from reablement programs.

Using the health care professional interface in Buddy Link, and individually broadcast to participants via VIPA at specified times throughout the day, using video demonstrations, and audio (participants with visual processing difficulties can be delivered content audio only) and written instructions based on participants and carers preference.

Study investigators will access the Buddy Link platform to quantify the regularity with which participants engage in the audio, visual and written strategies delivered by VIPA and the perceived value (this will be determined by voice response from participants to questions we deliver via VIPAs, e.g. “Did you find this video useful? Please respond yes, no, or I did not watch the video”; “How confident are you in completing this task out of 10” etc.). Participants’ voice responses to these questions will be recorded and saved to the Buddy Link database, enabling study investigators to review weekly and modify the intervention as required. The VIPA device usage data will be collected via anonymised (or de-idenfied) Amazon accounts and no personal information will be shared with Amazon as we will register the device for each participant using an anonymous account.

All study measurements can be completed at home and there are no travel requirements for participants. There are no additional costs associated with participating in this research project.
Participants will also receive a fortnightly email inviting them to report any technical errors or issues with the intervention they have experienced using an online form. Any issues will be followed up with a telephone call from the treating psychologist.
Intervention code [1] 325817 0
Lifestyle
Comparator / control treatment
The control group will receive an acceptable standard of usual care by receiving routine care which constitutes having their general practioner manage their health conditions and will receive generic information on improving memory and cognition through weekly reminders delivered via email and/or mail. There is no evidence that providing this type of general information results in behavioural change. The control group also will be delivered an Amazon Echo Show 8 device after completing their 12-week follow up assessment. They will not have access to the same software as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 334373 0
Feasibility as measured by greater than or equal to 70% retention in the study, this will be determined by an audit of the study database.
Timepoint [1] 334373 0
Upon conclusion of the study (12 weeks post-intervention commencement)
Primary outcome [2] 334375 0
Feasibility as measured by completion of greater than or equal to 66% of the personalised reablement strategy program by accessing the Buddy Link platform to quantify the regularity with which participants engage in the audio, visual and written strategies delivered via VIPA.
Timepoint [2] 334375 0
Upon conclusion of the study (12 weeks post-intervention commencement)
Primary outcome [3] 335692 0
Acceptability as measured by overall positive themes expressed by semi structured interviews.
Timepoint [3] 335692 0
At the completion of the study (12 week time-point)
Secondary outcome [1] 420426 0
To compare changes in scores on the Short Form Geriatric Depression Scale as a measure of depression
Timepoint [1] 420426 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [2] 420427 0
To compare changes in scores on the Illness Cognition Questionnaire as a measure of abnormal illness belief and behaviour.
Timepoint [2] 420427 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [3] 420428 0
To compare changes in scores on the Multifactorial Meta Cognition Questionnaire to assess several dimensions of metacognition thought to be relevant to psychopathology
Timepoint [3] 420428 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [4] 420429 0
To compare changes in scores on the Bayar Activities of Daily Living Scale as a measure of functional independence
Timepoint [4] 420429 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [5] 420430 0
To compare changes in scores on the Everyday Cognition Scale as a measure of cognitively mediated functional abilities
Timepoint [5] 420430 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [6] 420431 0
To compare changes in scores on the Zarit Burden Scale (carer only) as a measure of caregiver burden
Timepoint [6] 420431 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [7] 420432 0
To compare changes in scores on the Goal Attainment Scale to calculate the extent to which a patient’s goals are met.
Timepoint [7] 420432 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [8] 420434 0
Overall system Usability as measured by the system usability scale
Timepoint [8] 420434 0
Upon conclusion of the study (12 weeks post-intervention commencement)

Eligibility
Key inclusion criteria
Prospective participants must meet the following criteria including English-speaking, aged 60-89 years, reside anywhere in Australia, have a recent (less than 6 months) clinical diagnosis of early dementia (any type) or MCI by a Cognitive, Dementia and Memory Service (CDAMS) Clinic, Neuropsychologist or General Practitioner; have a home Wi-Fi network and smart devices and have a primary carer with at least 50% close contact during the 12-week period.
Minimum age
60 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be ineligible if they report currently being unable to walk across a room unaided; are non-English speaking or have difficulty communicating with study personnel or a VIPA device due to speech or hearing problems; unwilling to be randomised; planning to be away from the VIPA device is greater than 4 weeks during the 12-week intervention period; any disorder of such severity that life expectancy is less than 12 months, or any cognitive or physical impairment or disability that in the opinion of the study investigators would result in the participant having difficulty interacting with Buddy Link or performing personalized reablement program safely. These include
- Progressive neurological disorders including Parkinson’s Disease and multiple sclerosis;
- Schizophrenia, other psychotic disorders, bipolar disorder;
- Severe knee or hip arthritis that would interfere with ability to complete functional tests and the intervention;
- Lung disease requiring regular use of supplemental oxygen
- Renal disease requiring dialysis;
- Hyper- or hypothyroidism;
- Cardiovascular disease (including New York Heart Association (NYHA) Class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable cardiac defibrillator, or uncontrolled angina)
- Other disorder of such severity that life expectancy is less than 12 months;
- Stroke, hip or knee replacement, spinal surgery, myocardial infarction or major heart surgery in the past 6 months.

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)
An independent statistician responsible for randomisation external to the research team
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be block randomised (1:1) to a VIPA intervention group or control group stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study will recruit 30 participants (15 in each arm) for this trial as this is consistent with current sample size guidelines for feasibility studies. Repeated-measures ANCOVA with 2 factors (within factor of time: 0 and 3 months; between factor of group: VIPA or control) will be performed to compare changes between groups in other quantitative outcomes from surveys including Goal Attainment Scale, Short Form Geriatric depression scale, the Illness Cognition Questionnaire, the Multifactorial Meta Cognition Questionnaire, Bayar Activities of Daily Living Scale, Everyday Cognition Scale and Zarit Burden Scale will also be compared between groups using repeated-measures ANOVA. This feasibility trial will not be powered to identify treatment effects on secondary outcomes however, baseline and follow-up between group differences will be investigated to determine effect size and guide design of a full-scale trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313577 0
Government body
Name [1] 313577 0
Dementia Australia Research Foundation (Project Grant 2022)
Country [1] 313577 0
Australia
Primary sponsor type
Government body
Name
Dementia Australia Research Foundation
Address
155 Oak St, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 315364 0
None
Name [1] 315364 0
Address [1] 315364 0
Country [1] 315364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312758 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 312758 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Ethics committee country [1] 312758 0
Australia
Date submitted for ethics approval [1] 312758 0
01/04/2022
Approval date [1] 312758 0
14/07/2022
Ethics approval number [1] 312758 0
2022-043

Summary
Brief summary
The aim of this study is to conduct a 12-week feasibility and pilot randomised controlled trial of a co-designed home-based personalised reablement strategy program delivered via Voice-Controlled Intelligent Personal Assistants (VIPAs) in older adults aged 60-89 years with mild cognitive impairment (MCI) and/or dementia.

The primary aims are to assess study processes including acceptability, retention rates and adherence to the personalised reablement strategy program.

The secondary aims are to compare changes in scores on the Short Form Geriatric Depression Scale, the Illness Cognition Questionnaire, the Multifactorial Meta Cognition Questionnaire, Bayar Activities of Daily Living Scale, Everyday Cognition Scale and Zarit Burden Scale.

The primary hypothesis is that a 12-week VIPA-delivered home-based personalised reablement strategy program will be feasible and acceptable, as evidenced by greater than 70% retention in the study, completion of greater than 66% of the personalised reablement strategy program, and by overall themes of acceptability expressed through participant interviews.

The proposed study is significant as it has the potential to transform healthcare delivery for people with MCI and dementia. The novel VIPA lifestyle delivery method can reduce the need for regular face-to face care and increase implementation and adherence to evidence-based recommended care. This will ultimately lead to improved healthcare outcomes and reduced costs on a massive scale, especially given this telehealth method removes some of the barriers to implementation related to traditional telehealth and face-to-face methods and therefore is more easily scalable. It is anticipated that this research has the potential to support the need for future studies to explore cost-effectiveness of this telehealth approach in MCI and dementia. Future projects will explore the delivery of this project to reduce healthcare inequalities by providing high quality and cost-effective services to low-income individuals and people in remote and rural areas.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125802 0
Dr Paul Jansons
Address 125802 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 125802 0
Australia
Phone 125802 0
+61 402283624
Fax 125802 0
Email 125802 0
paul.jansons@deakin.edu.au
Contact person for public queries
Name 125803 0
Dr Paul Jansons
Address 125803 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 125803 0
Australia
Phone 125803 0
+61 402283624
Fax 125803 0
Email 125803 0
paul.jansons@deakin.edu.au
Contact person for scientific queries
Name 125804 0
Dr Paul Jansons
Address 125804 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 125804 0
Australia
Phone 125804 0
+61 402283624
Fax 125804 0
Email 125804 0
paul.jansons@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the Individual de-identified participant data collected during the trial
When will data be available (start and end dates)?
Data will be available at the end of the trial and there is no end date for data availability
Available to whom?
Data obtained from this study will be made available to other researchers by approval from PI Dr Paul Jansons
Available for what types of analyses?
Secondary analysis
Meta analysis
How or where can data be obtained?
Data obtained from this study will be made available to other researchers by approval from PI Dr Paul Jansons
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
+61 402283624
paul.jansons@deakin.edu.au


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.