Digital Technologies for Stroke Prevention Trial (DIGITS Trial)

The Intervention will be a combination of the two digital tools: The Intervention will be a complementary use of the two digital tools to provide personalised recommendations on secondary stroke prevention and support their implementation: (1) The PreventS-MD web app for clinicians (accessible through service-owned computers or tablets via a dedicated URL for the lifetime of the study), now referred to as a "web-app". (2) The Stroke Riskometer mobile-app for patients (free to download on smartphones or tablets for Android and iOS via Google Play and Apple Store, respectively) now referred to as "mobile-app”. These digital tools will be used sequentially. The web-app will be used by a healthcare professional to collect information about stroke risk factors, calculate stroke risk, and compose additional discharge summary that include tailored recommendations and explanation graphs. Personal nearest goals for the patient's health behaviour change will be optionally set using the PreventS-MD Goal-setting feature. The same information will be transferred via QR code to the patient’s mobile-app, for use by the patient post-discharge to follow these recommendations, including goal setting and medication reminders. (1) The PreventS-MD web app: The PreventS-MD web-app is built on the same core stroke risk assessment algorithm as the Stroke Riskometer mobile-app but is designed to be used by healthcare providers in conjunction with existing electronic patient management systems of outpatient clinics and hospitals and expanded by several additional features. Examples of stroke risk factors that will be used for the risk assessment algorithm are age, sex, ethnicity, smoking history, alcohol consumption, fruit and vegetable intake, physical activity, lipid and glucose levels, and medical history. At baseline, clinicians will complete the assessment using the Prevents-MD web app. Stroke Clinical Nurse or Stroke Physician will deliver the intervention. They will then have a consultation with participants to review the summary and provide necessary recommendations. A one-time 15–20-minute session is required to complete the Prevents-MD assessment and review the recommendations with the participant. At least two weeks before commencing the data collections all clinicians will receive training on the overview of the trial and the use of the web app. The training will take about two hours, with an additional one-hour mock session arranged. The Primary Investigator, Trial Manager, Assistant Manager, and Technical Support Team will present the relevant sections. The training will be delivered both in person and online (based on preference and availability of the clinicians). All sessions will be recorded, and the links will be shared via the study’s Microsoft Teams channel. These recordings, along with other materials such as study protocols and task checklists, will be available for review. After the assessment is completed, the web-app algorithm calculates both the absolute and relative 5- and 10-year risk of stroke, generates a comprehensive conclusion, and suggests recommendations on controlling the revealed risk factors. The clinician can easily compose the final summary by selecting necessary recommendations and graphs. Goal-setting options based on the assessments will be discussed with patients to motivate adherence to these recommendations. Goal-setting options based on the assessments will be discussed with patients by clinicians at baseline to motivate adherence to the given recommendations. The same information will be transferred via QR code to the patient’s Riskometer mobile app, for use by the participant post-discharge to follow these recommendations, including goal setting and medication reminders. If the intervention gets delivered before the participant gets discharged from the hospital it will be face-to-face. If the participant gets discharged, the clinician will deliver the intervention over the phone. Two examples of recommendations that the clinician can select to be given to the participants below: A) Smoking: Smoking cigarettes, pipes, or cigars increases your risk of heart attack and stroke by up to 60%. The longer a person is a smoker, the greater their risk of having a stroke and heart attack. Smoking electronic cigarettes (vaping) also significantly increases the risk of stroke and heart attack, compared to non-smokers, and does not help people quit smoking. Smoking narrows and hardens the blood vessels which carry blood throughout the body. This reduces blood flow and makes the blood more likely to clot. Smoking also contributes to brain aneurysms which are where the wall of a blood vessel is damaged, and it stretches out to form a balloon filled with blood. An aneurysm can burst and cause internal bleeding. Passive/second-hand smoking also increases the chances of having a stroke. If you stop smoking today, the risk of stroke and heart attack due to smoking will begin to drop immediately and after about 5 years your risk of stroke and heart attack as the result of smoking will virtually disappear. There are various methods of quitting smoking and advice, and support is available from you doctor and smoking cessation services. B) Sedentary lifestyle: Adequate physical activity will reduce your risk of stroke and also increase your physical fitness and emotional wellness. Adequate physical activity usually means moderate activity for 30-45 minutes, at least 4 times a week for adults and every day for children. Moderate activity is activity that makes you slightly warm and a little out of breath. Good examples of moderate activity are brisk walking, jogging, bicycling, swimming, and gardening. Importantly, physical activity must fit into your daily routine and be pleasant so that you enjoy doing it regularly. The key is to exercise regularly, however exercise does not have to be very strenuous or time consuming to be effective. For example, the health benefits of brisk walking are only slightly less than the benefits of jogging. If you have any health conditions you should consult your treating doctor before starting or changing your physical activity. (2) The Stroke Riskometer mobile-app: The Stroke Riskometer App is an evidence-based app that assesses an individual’s risk of stroke, based on user input on demographic and risk factor information. The risk factors are similar to the web-app and the intervention will be focused on lifestyle and medication adherence. On completion of the assessment, the App provides information on the pertinent risk factors identified for that individual, information in the management of these risk factors (including videos from relevant experts), options for goal setting and tracking lifestyle behaviours, medication reminders and other self-nominated reminders, (e.g., going for a walk), and information about stroke (signs, and actions to take). The app may be used for both the primary and secondary prevention of stroke. The app was developed and validated by Feigin and Krishnamurthi et.al. at the Auckland University of Technology (AUT) in collaboration with national and international experts, non-government organisations (NGOs), international researchers and community groups. The App’s stroke risk calculation algorithm was validated against the established Framingham Stroke Risk Score and Stroke and found to have comparable stroke risk prediction. The app also incorporates several evidence-based tools to promote behaviour change aligned with internationally recognised stroke prevention guidelines, including provision of absolute and relative risk of stroke; personalised risk factor profile and their management; goal setting and notifications to engage in behaviour modification; and information on stroke risk factors and warning signs; Face, Arm, Speech, Time (FAST). After the initial consultation using the web-app, clinicians will encourage participants to download and use the Stroke Riskometer App in their own time, etc. Personal nearest goals for the patient's health behaviour change will be optionally set using the PreventS-MD Goal-setting feature. The same information will be transferred via QR code to the patient’s mobile-app, for use by the patient post-discharge to follow these recommendations, including goal setting and medication reminders. The unblinded community support Research Assistants who will be trained on the use Stroke Riskometer app, will contact IG participants to support with the installation and troubleshooting of technical issues. The frequency and duration of engagement with the app will vary depending on the individual. At the 12-month follow-up, participants will complete the System Usability Scale (SUS) and be asked about the frequency of app usage over the last 3 months, as well as the average length of time spent using health apps per week (<30 min, 30-60 min, >60 min, >120 min). Adherence to the use of the app will be monitored solely through participants' self-reports via surveys. No monitoring data will be available from app analytics.