Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000307808
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
19/03/2021
Date last updated
3/03/2022
Date data sharing statement initially provided
19/03/2021
Date results information initially provided
3/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the Feasibility of Voice-Controlled Intelligent Personal Assistants for delivery of home-based lifestyle interventions in older adults with type II diabetes
Scientific title
Exploring the Feasibility of Voice-Controlled Intelligent Personal Assistants for delivery of home-based diet and exercise interventions in older adults with type II diabetes
Secondary ID [1] 303357 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes mellitus 320695 0
Obesity 320696 0
Condition category
Condition code
Diet and Nutrition 318541 318541 0 0
Obesity
Metabolic and Endocrine 318542 318542 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Working with an industry partner, we have developed innovative web-based software (Buddy Link) which allows Health professionals to deliver individually tailored lifestyle programs via an Amazon Alexa Echo Show 8 (Alexa) in patients' homes. Health professionals use our software to select various lifestyle behaviour instructions from a wide range of evidence-based options (or can easily create their own program), and these instructions are scheduled for broadcasting (using video and audio) by the Voice-Controlled Intelligent Personal Assistants (VIPA) at times specified by the health professional.

The intervention group will receive, via courier, an Alexa and will also be provided with instructions on connecting the device to their home WiFi and using standard Alexa functions like using voice instructions to set reminders and search for information. They will also receive access to our health professional facing software “Buddy Link” which enables delivery of an individualised lifestyle program, at specified times throughout the day, using video demonstrations, and audio and written instructions. The VIPA will broadcast questions to determine whether the participant completed the activity, self-perceived exertion, self-efficacy, and any concerns. Participants can respond to all questions using natural conversation.

The exercise physiologist will prescribe a personalised exercise program delivered by the Alexa to the intervention group for 12-weeks. Exercises will be selected by the exercise physiologist using the health professional interface in Buddy Link, and individually broadcast to participants via Alexa at specified times throughout the day, using video demonstrations, and audio and written instructions based on Exercise and Sport Science Australia guidelines.

The prescribed exercise program will use body weight or additional resistance such as weight plates, dumbbells, theraband, weight vests etc if the participant has access to them unless contraindicated. Participants will perform up to 3 sets of 5 repetitions of upper limb and lower limb exercises at a moderate-intensity of approximately 4-6 on the 10-point modified Rating of Perceived Exertion (RPE) scale. Each participant will be encouraged to increase the load of all the prescribed exercises each session while maintaining the desired intensity if able. throughout the intervention duration. Each session will be 20-30 minutes in duration. The protocol will initially deliver two exercise sessions per week for the first four weeks of the intervention, three exercise sessions per week for the second four weeks, and four exercise sessions per week for the final four weeks. Following each exercise, the Alexa will broadcast questions to determine whether the participant completed the exercise, their self-perceived exertion, and any concerns (e.g. Pain, dizziness). Participants’ responses to these questions will be recorded and saved to the Buddlink database, enabling the exercise physiologist to review weekly and modify or progress exercise prescriptions as required.

In addition, we have developed a novel automated “decision to exercise tree” based on the current recommendations of American Diabetes Association. VIPA devices will provide Blood glucose level (BGL) monitoring reminders pre and post each exercise session for the first 3 sessions (minimum) to establish exercise response/patterns/control. For example, the decision tree not deliver exercise if participants have signs or symptoms of hypoglycaemia or have self-reported BSL less than 4.0mmol/L or are not feeling well enough to exercise. Instead the decision tree will deliver audio and video instructions on how to self-administer their personalised hypoglycaemia action plan. If a pattern of three sessions in a row of self-reported BSLs less than 4.0mmol/L or greater than 15.0mmol/L occurs the decision tree system will request a referral to their GP or endocrinologist for completion of a Diabetes Management Plan.

The study dietician will prescribe a healthy eating program delivered by the Alexa to the intervention group for 12-weeks to increase whole grains, vegetable and fruit daily intake in line with the Australian Dietary Guidelines. In addition, generalised dietary educational videos tailored for type 2 diabetes management will be displayed by Alexa. Examples of videos delivered by Alexa include “meal planning”, “making shopping lists using VIPA” and “healthy snacking”. We will access the Buddy Link platform to quantify the regularity with which participants watch these health eating videos (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”). The protocol will deliver two videos per week for the duration of the 12 week intervention.
Intervention code [1] 319711 0
Lifestyle
Comparator / control treatment
The control group will will receive information on improving physical activity and nutrition from the Diabetes Australia website through fortnightly reminders delivered via email. They will not receive an Alexa device.
Control group
Active

Outcomes
Primary outcome [1] 326500 0
Feasibility as measured by recruitment greater than or equal to 20% of eligible participants. This will be determined by an audit of the study database.
Timepoint [1] 326500 0
follow-up (12 weeks post-intervention commencement)
Primary outcome [2] 326809 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 [2] 326809 0
follow-up (12 weeks post-intervention commencement)
Primary outcome [3] 326810 0
Feasibility as measured by completion of greater than or equal to 66% of prescribed exercise and dietary advice,this will be determined by an audit of the study database.
Timepoint [3] 326810 0
follow-up (12 weeks post-intervention commencement)
Secondary outcome [1] 391690 0
Change in Work Productivity and Activity Impairment as assessed by the Work Productivity and Activity Impairment Questionnaire
Timepoint [1] 391690 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [2] 391691 0
Change in Quality of Life as assessed by EuroQol-5D-5L
Timepoint [2] 391691 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [3] 391692 0
Change in Objective assessment of physical activity as assessed by actigraph wGT9XLink accelerometer. Physical activity data measured will be steps/day, moderate and vigorous activity.
Timepoint [3] 391692 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [4] 391693 0
Change in 24-hour Food Recall to determine fruit intakes as assessed by the ASA24-Australia-2016
Timepoint [4] 391693 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [5] 391694 0
Change in System Usability as measured by the system usability scale
Timepoint [5] 391694 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [6] 391695 0
Change in diabetes self management as assessed by the Diabetes Self-Management Questionnaire (DSMQ)
Timepoint [6] 391695 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [7] 392749 0
Change in Objective assessment of sleep time as assessed by actigraph wGT9XLink accelerometer. Sleep data will measured in sleep time.
Timepoint [7] 392749 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [8] 392750 0
Change in Objective assessment of sedentary time as assessed by actigraph wGT9XLink accelerometer. Sedentary data measured will be sedentary time.
Timepoint [8] 392750 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [9] 392751 0
Change in 24-hour Food Recall to determine whole grain intakes as assessed by the ASA24-Australia-2016
Timepoint [9] 392751 0
Baseline and follow-up (12 weeks post-intervention commencement)
Secondary outcome [10] 392752 0
Change in 24-hour Food Recall to determine vegetable intakes as assessed by the ASA24-Australia-2016
Timepoint [10] 392752 0
Baseline and follow-up (12 weeks post-intervention commencement)

Eligibility
Key inclusion criteria
Prospective participants must be aged 50-75 years; English-speaking; have a body mass index greater than or equal to 30 kg/m2, able to walk across a room unaided; with access to a smartphone connected to an internet network; willing to complete a 12-week lifestyle intervention and also be willing to participate should they be randomised to either intervention arm.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are 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 for greater than or equal to 4 weeks during the 12-week intervention period; severe knee or hip osteoarthritis (awaiting a joint replacement) that would interfere with ability to complete exercise; recent fracture (past 3 months) limiting exercise; renal disease requiring dialysis; and any other 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 unsupervised exercise safely. Participants who answer ‘yes’ to any of six questions on the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool will also be excluded. This is a validated and recommended pre-exercise screening tool for ensuring safety for exercise at moderate exertion, endorsed by Australia’s peak exercise body (ESSA).

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 central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to home-based exercise and diet intervention delivered by an Alexa device or home-based aerobic exercise (control) using computer-generated block randomisation of numbers.
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
We will recruit 50 participants (25 in each arm) for this trial as this is consistent with current sample size guidelines for feasibility studies . Sample sizes of 25 participants per arm are recommended for pilot studies as they are capable of detecting small effect sizes (0.2) with 90% power and two-sided significance of 5%. 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 DSMQ, EQ-5D-5L, Work Productivity and Activity Impairment Questionnaire and physical activity from accelerometers 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
Completed
Date of first participant enrolment
Anticipated
1/04/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
1/09/2021
Actual
8/11/2021
Date of last data collection
Anticipated
1/12/2021
Actual
8/02/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307771 0
University
Name [1] 307771 0
Deakin University
Country [1] 307771 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 308473 0
None
Name [1] 308473 0
Address [1] 308473 0
Country [1] 308473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307793 0
Deakin University
Ethics committee address [1] 307793 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Ethics committee country [1] 307793 0
Australia
Date submitted for ethics approval [1] 307793 0
06/01/2021
Approval date [1] 307793 0
09/03/2021
Ethics approval number [1] 307793 0

Summary
Brief summary
We will conduct a 12-week feasibility and pilot randomised controlled trial of a personalised exercise and dietary intervention delivered via VIPAs in adults aged 50 to 75 years with oral hypoglycaemic agent-controlled type 2 diabetes mellitus (T2DM).
Primary Aim:
Our primary aim is to assess study processes including recruitment and retention rates, adherence to the exercise and nutrition intervention, acceptability and adverse events.
Secondary Aim:
Secondary aims are to compare changes in scores for the Diabetes Self-Management Questionnaire (DSMQ), objectively-assessed physical activity, self-reported fruit and vegetable intakes, health-related quality of life (EQ-5D-5L) and productivity, compared to a control group receiving general advice on physical activity and healthy eating via email.
Hypotheses:
Our primary hypothesis is that a 12-week home-based personalised exercise and dietary intervention delivered by VIPA will be feasible and acceptable, as evidenced by greater than or equal to 70% retention in the study, completion of greater than or equal to 66% of prescribed exercise and dietary advice, recruitment greater than or equal to 20% of eligible participants and overall themes of acceptability expressed. We also hypothesise that the VIPA group will demonstrate improvements in diabetes self-management, objectively-determined physical activity, health-related quality of life, self-reported fruit and vegetable intakes and direct and indirect productivity.

We anticipate that these preliminary data will support the need for future studies to explore cost-effectiveness of this telehealth approach in Type 1 or 2 insulin dependent diabetes mellitus and gestational diabetes. This innovative model of service delivery has the potential to markedly reduce health care practitioner workloads and telehealth costs in type 2 diabetes management, while increasing empowerment and accessibility to evidence-based programs for patients most at need
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108514 0
Dr Paul Jansons
Address 108514 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 108514 0
Australia
Phone 108514 0
+61 402283624
Fax 108514 0
Email 108514 0
[email protected]
Contact person for public queries
Name 108515 0
Dr Paul Jansons
Address 108515 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 108515 0
Australia
Phone 108515 0
+61 402283624
Fax 108515 0
Email 108515 0
[email protected]
Contact person for scientific queries
Name 108516 0
Dr Paul Jansons
Address 108516 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 108516 0
Australia
Phone 108516 0
+61 402283624
Fax 108516 0
Email 108516 0
[email protected]

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
[email protected]


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.