Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000147886p
Ethics application status
Submitted, not yet approved
Date submitted
16/12/2020
Date registered
12/02/2021
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Intelligent Personal Assistants for Delivering Telehealth to Postmenopausal Women with Osteoporosis
Scientific title
A Pilot Feasibility Trial of Voice-Controlled Intelligent Personal Assistants as a Telehealth Self-Management Tool for Postmenopausal Women with Osteoporosis
Secondary ID [1] 303030 0
None
Universal Trial Number (UTN)
Trial acronym
INTERPRETER-OS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoporosis 320103 0
postmenopausal osteoporosis 320346 0
Condition category
Condition code
Musculoskeletal 318038 318038 0 0
Osteoporosis
Reproductive Health and Childbirth 318585 318585 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will recruit 50 postmenopausal women with osteoporosis who have current prescriptions for anti-osteoporosis medication. We will randomly allocate 25 women to receive a voice-controlled intelligent personal assistant (VIPA) device (Amazon Alexa) that will provide regular medication reminders and education related to fracture risk factors, a home-based exercise program, and nutritional advice (delivered using both audio and video functions of the VIPA device), for six months. The educational material will be specifically designed for this study and approximately 18 <5 minute education videos will be delivered over 6 months (one per month for each of medication, exercise and nutrition). Educational videos will be displayed on the Amazon Alexa device when participants access the software using voice commands. In addition, participants will receive exercise instructions on three days per week for the entire six-month intervention which will include progressive home-based activities focused on improving strength, balance and bone health (using impact exercises like hopping and jumping). While the exercise and nutritional programs are not personalised, the medication program will be tailored to be specific to the participant's reported osteoporosis medication. Exercise will be progressed over time by increasing the number of activities completed per session (4 activities per session for the first two-month period, 8 activities per session for the second two-month period, and 12 activities per session for the third two-month period), generally corresponding with an increase in duration of exercise sessions from 10-15 minutes per session to approximately 30 minutes per session. Adherence to accessing educational material will be determined by participant responses to questions broadcast by Alexa at the completion of educational videos. Similarly, exercise adherence will be determined by responses to questions regarding exercise.
Intervention code [1] 319321 0
Lifestyle
Intervention code [2] 319514 0
Behaviour
Comparator / control treatment
The remaining 25 women will receive general information about managing osteoporosis via monthly emails. The general information will be accessed via links to the Osteoporosis Australia website which provides content on osteoporosis, medications, exercise and nutrition. Participants will receive one email per month for six months, each with a link to different educational content on the Osteoporosis Australia website.
Control group
Active

Outcomes
Primary outcome [1] 326029 0
Medication adherence assessed using the Medication Possession Ratio (MPR; the percentage of time the participant has access to a prescribed osteoporosis medication)
Timepoint [1] 326029 0
Baseline
12 months post-intervention commencement
Secondary outcome [1] 389907 0
Osteoporosis knowledge assessed using the Osteoporosis Knowledge Assessment Tool (OKAT)
Timepoint [1] 389907 0
Baseline
6 months post-intervention commencement
12 months post-intervention commencement
Secondary outcome [2] 389909 0
Physical activity (objectively determined by wrist-worn accelerometer)
Timepoint [2] 389909 0
Baseline
6 months post-intervention commencement
12 months post-intervention commencement
Secondary outcome [3] 389910 0
Dietary nutrient intakes assessed using Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Timepoint [3] 389910 0
Baseline
6 months post-intervention commencement
12 months post-intervention commencement
Secondary outcome [4] 389911 0
Work productivity and activity assessed using the Work Productivity and Activity Impairment Questionnaire: General Health V2.0.
Timepoint [4] 389911 0
Baseline
6 months post-intervention commencement
12 months post-intervention commencement
Secondary outcome [5] 389912 0
Health-related quality of life assessd using the EQ-5D-5L
Timepoint [5] 389912 0
Baseline
6 months post-intervention commencement
12 months post-intervention commencement
Secondary outcome [6] 389915 0
Falls efficacy assessed using the Modified Falls Efficacy Scale
Timepoint [6] 389915 0
Baseline
6 months post-intervention commencement
12 months post-intervention commencement
Secondary outcome [7] 389916 0
VIPA device usage assessed via review of recorded interactions with Alexa in our database.
Timepoint [7] 389916 0
6 months post-intervention commencement.
Secondary outcome [8] 390699 0
Osteoporosis medication behaviours assessed using the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire
Timepoint [8] 390699 0
Baseline
6 months post-intervention commencement
12 months post-intervention commencement
Secondary outcome [9] 390700 0
VIPA device acceptability assessed via semi-structured interviews
Timepoint [9] 390700 0
Baseline and 6 months after intervention commencement

Eligibility
Key inclusion criteria
English-speaking, women aged 50 years and older who have experienced menopause, self-reported diagnosis of osteoporosis and is currently receiving an approved drug treatment on a monthly, six-monthly or annual schedule, safely able to complete an unsupervised home-based exercise program, has a Medicare number and is willing to consent to data linkage, and has access to a personal email address via home computer/tablet/smartphone and a home Wi-Fi network.
Minimum age
50 Years
Maximum age
No limit
Sex
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 6-month 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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed at time of recruitment as allocation to study groups is performed only after collection of baseline data and using a randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Immediately following completion of baseline measurements, participants will be block randomised (1:1 group allocation; random block sizes of 4, 6 and 8), stratified by medication prescription interval (monthly, biannually, or annually) to the VIPA intervention group or usual care control group. The block randomisation schedule has been generated via Sealed Envelope (https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 10 Nov 2020]).
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
Statistical methods / analysis
Quantitative measures
At the completion of the study, all data will be entered into a secure Microsoft Access database. Data will be exported to an SPSS/Stata file and each variable inspected for data errors. In the case of missing or spurious data, original files will be consulted to identify the correct values. When correct values cannot be confirmed, the data point will be classified as missing. Non-normal data will be transformed to meet normality assumptions of parametric methods, or non-parametric methods will be used where appropriate. For the primary outcome of medication adherence, we will use Fisher’s exact test to compare between-group proportions of participants who are adherent (defined as Medication Possession Ratio (MPR) greater than or equal to 80%). Repeated-measures ANOVA with 2 factors (within factor of time: 0, 6 and 12 months; between factor of group: VIPA or control) will be performed to compare changes between groups in other quantitative outcomes from surveys, ASA24 and physical activity data. Effect sizes will be reported and these analyses will allow us to determine whether effects of the six-month VIPA intervention on osteoporosis self-management behaviours is maintained over the subsequent six-month follow-up period.
Within the VIPA group only, paired-samples t-tests will compare baseline and 6-month system usability responses. A modified thematic framework will be used to analyse interview data. NVivo computer software (version 12, QSR International Pty Ltd, Doncaster, Victoria, Australia) will be used to code, chart and map the data. Five stages of coding will be completed: i) Familiarisation; ii) Identifying a thematic framework; iii) Indexing; iv) Charting; and v) Mapping and Interpretation. An iterative process will then be used to test and retest the thematic framework. Two authors will then compare content and themes. Any disagreement will be resolved by consensus moderation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 18231 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 32290 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 307441 0
Charities/Societies/Foundations
Name [1] 307441 0
Osteoporosis Australia
Country [1] 307441 0
Australia
Funding source category [2] 307442 0
Commercial sector/Industry
Name [2] 307442 0
Amgen Australia Pty Ltd
Country [2] 307442 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] 308117 0
None
Name [1] 308117 0
Address [1] 308117 0
Country [1] 308117 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307522 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 307522 0
Ethics committee country [1] 307522 0
Australia
Date submitted for ethics approval [1] 307522 0
06/01/2021
Approval date [1] 307522 0
Ethics approval number [1] 307522 0

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

Contacts
Principal investigator
Name 107538 0
A/Prof David Scott
Address 107538 0
Deakin University Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 107538 0
Australia
Phone 107538 0
+61 3 9246 8438
Fax 107538 0
Email 107538 0
[email protected]
Contact person for public queries
Name 107539 0
David Scott
Address 107539 0
Deakin University Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 107539 0
Australia
Phone 107539 0
+61 3 9246 8438
Fax 107539 0
Email 107539 0
[email protected]
Contact person for scientific queries
Name 107540 0
David Scott
Address 107540 0
Deakin University Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 107540 0
Australia
Phone 107540 0
+61 3 9246 8438
Fax 107540 0
Email 107540 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 participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months and ending 15 years following main results publication.
Available to whom?
Researchers who provide a methodologically sound proposal at the discretion of the Principal Investigator.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]), and after approval by the Deakin University Human Research Ethics Committee.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10066Study protocol  [email protected]
10067Statistical analysis plan  [email protected]
10068Informed consent form  [email protected]
10069Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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