None listed
Conditions
Brief summary
This research study will conduct a pilot evaluation of the Salvio digital platform to ascertain a preliminary understanding of the potential benefits to participants and their experiences of use. The research team has developed a platform that brings together various behaviour change programs into a common portal for self-management of heart disease. The platform enables users to customise their experience using a suite programs and tools. Participants will be able to choose from the technology and type of support that suits them to best self-manage their condition. Participation in this research study will require adults (>18 years) living with cardiovascular disease to trial the Salvio digital platform for a 6-week period and actively provide feedback to inform future development. During this time, participants can remotely access the platform alongside their usual care. They will create a profile and use an online decision support tool to guide them to the digital intervention that is best suited to their particular needs and preferences. Participants can choose to enrol in one or more of the interventions presented and will be able to view their progress on a personalised Salvio dashboard.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Exclusion criteria
None