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Trial registered on ANZCTR


Registration number
ACTRN12620001090909
Ethics application status
Approved
Date submitted
15/08/2020
Date registered
20/10/2020
Date last updated
20/10/2020
Date data sharing statement initially provided
20/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot evaluation of a digital platform to support self-management of cardiovascular disease
Scientific title
Pilot evaluation of a digital platform to support self-management of cardiovascular disease
Secondary ID [1] 302040 0
None
Universal Trial Number (UTN)
U1111-1257-0106
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 318622 0
Health Behaviours 318623 0
Condition category
Condition code
Cardiovascular 316640 316640 0 0
Other cardiovascular diseases
Diet and Nutrition 316641 316641 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 316642 316642 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will access the Salvio digital platform for a 6-week period, alongside their usual care. According to the Australian Heart Foundation (2018), usual care for people living with CVD typically includes taking regular medication, attending cardiac rehabilitation, and follow-up appointments with a multidisciplinary healthcare team. The Salvio digital platform has been specifically designed and developed for this study, using a participatory design approach with potential end-users. The platform itself consists of a web-based landing page, electronic decision support tool (online questionnaire) and a personalized user dashboard. The platform also hosts a palette of discrete digital health solutions, that are evidence-based and shown to be effective for supporting CVD self-management and health behaviour change.

In theory, Salvio could host an infinite amount of digital health solutions, but for the purpose of this pilot trial there will be three separate validated, evidence-based programs (SCRAM, HEART, Text4Heart). SCRAM, previously named REMOTE-CR (Maddison et al., 2019), provides participants with a personal coach in their pocket by remotely connecting them with accredited exercise physiologists via a bespoke telerehabilitation application. They can access real-time support from clinical exercise specialists while exercising in their home or local environment and receive evidence- and theory-based behavioural support. A BioHarness is worn by participants to facilitate real-time monitoring. Exercise prescription will be increased progressively to meet participants’ needs, with a target of 3–5 weekly sessions of 60 minutes. HEART (Maddison et al., 2015) and Text4Heart (Pfaeffli Dale et al., 2015) are both one-way text messaging/SMS intervention. Participants are sent 1-2 text messages per day for 6 weeks. HEART SMS content aims to support participants to achieve moderate to vigorous aerobic-based exercise for a minimum of 30 minutes (preferably more) most days (at least 5) of the week, in line with current recommendations. Text4Heart SMS content aims to educate participants about their cardiovascular risk factors and support them to make relevant lifestyle changes.

Participants are not obliged to enroll in all three of the interventions. The electronic decision support tool will guide participants to the program that is best suited to their individual needs and preferences. In order to determine suitability, this online tool asks participants a series of questions relating to their overall health objectives, current health behaviour, and usual use of technology. A backend intervention logic system has been created for the Salvio eDecision tool. It categorises program features and aligns them with participant characteristics in order to determine suitability and provide a choice of program. Therefore, based on their answers, Salvio will offer the participant a choice of one, two or three of the programs.

There is no minimum requirement for platform use. Participants will initially create a profile on Salvio and then use the platform as much or as little as they need. Frequencies and durations of use will be monitored through online platform analytics and will be assessed to inform our composite ‘platform use’ outcome (primary outcome 1). As there is no minimum requirement for platform use, we are not assessing adherence, but we will monitor trial and program dropout rates over the 6-week period.

Salvio is an online intervention, but access/background management of the intervention will be provided by a member of the research team (ST) who is also a healthcare professional (exercise physiologist). Remote exercise sessions (via REMOTE-CR) are facilitated by two healthcare professionals (exercise physiologists). The research team and a technology development team will also available throughout the pilot trial, to support participants and minimise any unexpected adverse effects.

References

Atherton, J.J., Sindone, A., De Pasquale, C.G., Driscoll, A., MacDonald, P.S., Hopper, I., Kistler, P.M., Briffa, T., Wong, J., Abhayaratna, W. and Thomas, L., 2018. National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: guidelines for the prevention, detection, and management of heart failure in Australia 2018. Heart, Lung and Circulation, 27(10), pp.1123-1208.

Maddison, R., Pfaeffli, L., Whittaker, R., Stewart, R., Kerr, A., Jiang, Y., Kira, G., Leung, W., Dalleck, L., Carter, K. and Rawstorn, J., 2015. A mobile phone intervention increases physical activity in people with cardiovascular disease: Results from the HEART randomized controlled trial. European journal of preventive cardiology, 22(6), pp.701-709.

Maddison, R., Rawstorn, J.C., Stewart, R.A., Benatar, J., Whittaker, R., Rolleston, A., Jiang, Y., Gao, L., Moodie, M., Warren, I. and Meads, A., 2019. Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial. Heart, 105(2), pp.122-129.

Pfaeffli Dale, L., Whittaker, R., Jiang, Y., Stewart, R., Rolleston, A. and Maddison, R., 2015. Text message and internet support for coronary heart disease self-management: results from the Text4Heart randomized controlled trial. Journal of medical Internet research, 17(10), p.e237.
Intervention code [1] 318342 0
Rehabilitation
Intervention code [2] 318343 0
Lifestyle
Intervention code [3] 318344 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324769 0
Primary Outcome [1]: Platform Use (Composite)

Outcome Assessed Using:
- Measure 1: Website/Platform Analytics
[Analytic data will include: recruitment data, registration data, dropout data, technological issue log, number of platform log-ins per user per week, minutes logged-in to platform per user per week, intervention selection data].
Timepoint [1] 324769 0
Week 6 (Post-Intervention Follow-Up)
Primary outcome [2] 324778 0
Primary Outcome [2]: Participant experience (Composite)

Outcome Assessed Using:
- Measure 1: Telephone individual semi-structured interview (30 minute)

- Measure 2: Online REDCap Survey
[Two Question Survey with Likert Scale Response: How satisfied are you with the Salvio digital platform; How likely is it that you would recommend the Salvio Digital Platform to a friend or family member who has a diagnosis of cardiovascular disease?]
Timepoint [2] 324778 0
Week 6 (Post-Intervention Follow-Up)
Secondary outcome [1] 385713 0
Secondary Outcome [1]: Health Behaviour Change (Composite)

Outcome Assessed Using:
- Measure: Online REDCap Survey
[Survey includes single-item questions on: height (cm), weight (kg), smoking status, alcohol use (frequency), health of overall diet (likert scale), physical activity days/week, hours spent sitting per day]
Timepoint [1] 385713 0
Week 0 (Baseline) & Week 6 (Post-Intervention Follow-Up)
Secondary outcome [2] 385716 0
Secondary Outcome [2]: Clinical Change

Outcome Assessed Using:
- Measure: Online REDCap Visual analogue scale as part of EQ-5D-5L
[VAS: patients can mark their current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state)]
Timepoint [2] 385716 0
Week 0 (Baseline) & Week 6 (Post-Intervention Follow-Up)
Secondary outcome [3] 385717 0
Secondary Outcome [3]: Health-Related Quality of Life

Outcome Assessed Using:
- Measure: Euroqol-5D (EQ-5D-5L).
[Includes five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression]
Timepoint [3] 385717 0
Week 0 (Baseline) & Week 6 (Post-Intervention Follow-Up)
Secondary outcome [4] 385718 0
Secondary Outcome [4]: Adverse Effects

Outcome Assessed Using:
- Measure: Telephone individual semi-structured interview (30 minute)
Timepoint [4] 385718 0
Week 6 (Post-Intervention Follow-Up)

Eligibility
Key inclusion criteria
Eligible participants will have a documented clinical diagnosis of cardiovascular disease, be community dwelling outpatients (clinically stable), have access to internet (web-based access via computer, tablet or smartphone) and be able to read and understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative Analysis
The main analysis will be conducted using SPSS. Any discrepancies will be reported and their implications discussed. Descriptive statistics will be calculated for all participants. A Senior Research Fellow at School of Exercise & Nutrition Sciences (Deakin University) will oversee the analyses.

Qualitative Analysis
Follow-up interviews with participants will be audio-recorded and transcribed. Feedback from interviews will be analysed using thematic analysis in a step-by-step manner, which has been well-reported for the use in health research (Braun & Clarke 2006). This approach involves becoming familiar with the data, generating initial codes, searching for themes among codes, and finally reviewing and defining codes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 306461 0
University
Name [1] 306461 0
Deakin University
Country [1] 306461 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 306988 0
None
Name [1] 306988 0
Address [1] 306988 0
Country [1] 306988 0
Other collaborator category [1] 281428 0
University
Name [1] 281428 0
University of Copenhagen
Address [1] 281428 0
Øster Farimagsgade 5
P.O.B 2099
1014 Copenhagen K
Country [1] 281428 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306666 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 306666 0
Ethics committee country [1] 306666 0
Australia
Date submitted for ethics approval [1] 306666 0
Approval date [1] 306666 0
01/07/2020
Ethics approval number [1] 306666 0
DUHREC 2020-042

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

Contacts
Principal investigator
Name 104614 0
Prof Ralph Maddison
Address 104614 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise & Nutrition Sciences
Faculty of Health
Deakin University
Melbourne Burwood Campus
221 Burwood Highway,
Burwood,
VIC 3125
Country 104614 0
Australia
Phone 104614 0
+61 3 9246 8383
Fax 104614 0
Email 104614 0
ralph.maddison@deakin.edu.au
Contact person for public queries
Name 104615 0
Sarah A Tighe
Address 104615 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise & Nutrition Sciences
Faculty of Health
Deakin University
Melbourne Burwood Campus
221 Burwood Highway,
Burwood,
VIC 3125
VIC 3125
Country 104615 0
Australia
Phone 104615 0
+61 3 9246 8383
Fax 104615 0
Email 104615 0
stighe@deakin.edu.au
Contact person for scientific queries
Name 104616 0
Sarah A Tighe
Address 104616 0
Institute for Physical Activity and Nutrition (IPAN)
School of Exercise & Nutrition Sciences
Faculty of Health
Deakin University
Melbourne Burwood Campus
221 Burwood Highway,
Burwood,
VIC 3125
Country 104616 0
Australia
Phone 104616 0
+61 3 9246 8383
Fax 104616 0
Email 104616 0
stighe@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be made available for this pilot evaluation but research study results will be published. No identifying information will be published. If requested participants will be sent a copy of a lay summary of the research outcomes, all data provided in this lay summary will be de-identified to protect the privacy of other participants. Original digital or paper files associating the study identifier with participant identity will be stored in secure locations for 5 years following final publication.


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.