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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000898651
Acronym
VOICE-COG
Enrollment
30
Registered
2023-08-22
Start date
2023-09-13
Completion date
2024-06-04
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 y

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.

Sponsors

Dementia Australia Research Foundation
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to 89 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026