Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM): A 21st Century Approach for Improving the Self-Management of Heart Disease

OVERVIEW Participants randomised to the intervention arm will receive 24 weeks of usual care cardiac rehabilitation plus the 24-week Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) program. USUAL CARE CARDIAC REHABILITATION Usual care typically includes support and education to adhere to medical treatment and health-promoting lifestyle behaviours; some healthcare providers also offer supervised exercise programs. Specific service provision to individual participants may vary depending on their geographic location, in line with the services offered by their local healthcare provider. Access to usual care will be self-initiated. As no medication will be administered participants will be free to take any medications they have been prescribed. Medication use will be recorded at baseline, including generic medication names, initial prescription dates, and frequencies of administration. Changes to prescribed medications during the treatment period will be recorded at follow-up as required. SCRAM PROGRAM SCRAM is a dual-phase tailored intervention that comprises remotely supervised exercise training plus evidence- and theory-based behaviour change and education support to optimise self-management of cardiovascular risk factors. SCRAM will be delivered via a bespoke telerehabilitation platform that includes a participant-facing smartphone application, cardiac rehabilitation specialist-facing web application, and cloud-based data management system. SCRAM aims to support individuals to exercise, adhere to prescribed medications, make relevant health-promoting lifestyle changes, and educate them about their modifiable cardiovascular risk factors. Recommended lifestyle changes include regular exercise, decreasing salt, saturated fat and alcohol consumption, and increasing fruit and vegetable consumption. SCRAM includes a 12 week initiation phase followed by a 12 week maintenance phase. The initiation phase will provide intensive support to engage in exercise and lifestyle behaviour change to improve cardiovascular risk factor profile. The maintenance phase will provide lower intensity support designed to assist participants' transition towards independent exercise and self-management behaviours, and promote long-term adherence to health behaviour changes. Exercise training: Initiation Phase (weeks 1-12) At preferred times during pre-defined operating hours, participants will use the bespoke SCRAM telerehabilitation platform to connect with a remotely-located exercise physiologist to receive real-time exercise supervision and coaching. Participants will self-fit a wearable sensor (Zephyr BioHarness 3, worn around the chest) and activate the SCRAM smartphone app to transmit physiological (single lead ECG, heart rate, respiratory rate) and geospatial data (location, distance, speed, elevation, gradient) to exercise physiologists in real-time. Participants will receive real-time coaching, feedback, and support from exercise physiologists (see below), delivered as audio notifications via the SCRAM smartphone app. Participants will be recommended to use earphones to optimise the audio notification user experience, but messages will also be audible via integrated smartphone speaker(s) if required. Participants will use the SCRAM app for “offline” self-monitoring of exercise performance and CVD risk factors, goal setting and reviewing goal achievement feedback, and to receive evidence- and theory-based behavioural change support content via direct messages. All intervention group participants will complete a bespoke training module, receive an illustrated user guide, and have access to technical support via email and/or telephone if required. Participants will be loaned a smartphone if required and receive a voucher to cover mobile broadband costs. Exercise physiologists will use the SCRAM web app to monitor participants’ location, distance, speed, heart rate, single lead ECG, and self-reported cardiac symptoms (if relevant) in realtime throughout exercise. These features will support optimal individualisation and progression of exercise prescription throughout the 12-week intensive intervention phase. Exercise physiologists will also use the web app to provide participants with regular coaching instruction, feedback and support during exercise. Coaching interactions will be delivered to participants via the SCRAM smartphone app as audio alerts, instant/direct messages, push notifications, and/or telephone calls. Participants can be monitored in any environment with an active Wi-Fi or 3G/4G broadband connection, and the platform supports simultaneous monitoring of multiple participants. Exercise physiologists will receive comprehensive training to deliver these intervention components. Exercise physiologists will provide participants with an individualised exercise prescription based on their clinical status, exercise capacity, exercise-induced cardiac signs and symptoms (if any), age, sex, and personal preferences. Prescription will follow ACSM guidelines for cardiac populations. Exercise frequency, duration, intensity level (percentage of heart rate reserve [%HRR]) targets will be delivered via the SCRAM smartphone app. Initial prescription will target 3 sessions per week of 30–40 minutes duration at 40–50%HRR. Exercise prescription parameters will be increased progressively according to participants’ exercise tolerance, signs and symptoms, and clinical status, and will target 3–5 weekly sessions of 60 minutes at 65–85%HRR. Prescribed exercise intensity will be sufficient to induce physiological adaptation while remaining below a metabolic load that evokes abnormal clinical signs or symptoms. All exercise training sessions will include warm up and cool down phases to enable appropriate cardiovascular and musculoskeletal preparation and recovery. The preferred mode of exercise will be walking, although participants are able to choose other modes (e.g. cycling, rowing) in line with their preferences and access to requisite exercise equipment. Exercise training: Maintenance Phase (weeks 13-24) SCRAM participants will receive lower intensity support from exercise physiologists during the maintenance phase. Participants will be encouraged to continue to quantify their exercise performance using the SCRAM smartphone app and wearable sensor throughout; however, they will not receive real-time supervision and coaching from exercise physiologists. Participants will be able to view real-time performance data via the SCRAM smartphone app during exercise training, and review individualised summary statistics and goal achievement feedback outside of exercise training to support self-monitoring. Exercise physiologists will undertake regular retrospective review of participants’ recorded exercise adherence and performance data—via the SCRAM web app—to inform individualised feedback and modification of exercise prescription as required. Non-adherence will initiate prompts via the app (alerts, direct messages, and/or push notification) to promote engagement. Self-management behavioural sport: Initiation Phase (weeks 1-12) SCRAM participants will receive evidence- and theory-based self-management strategies to facilitate lifestyle behaviour change initiation and adherence-via the SCRAM smartphone app-in the form of instant/direct messages and/or push notifications. Content will include information and cognitive (e.g. goal setting, barrier resolution), behavioural (e.g. self-monitoring) and environmental (e.g. leveraging social support) strategies to support general heart health, physical activity, diet, reducing alcohol consumption, medication adherence, and (if indicated) smoking cessation. Content may be in the form of text, audio, still or moving image, and/or web-linked content. Self-management support will be delivered 4–5 times per week during the initiation phase. Some interactions will include prompts or cues to action, others will involve theory-and evidenced-based strategies to initiate and maintain health behaviour change. Self-management behavioural sport: Maintenance Phase (weeks 13-24) Self-management support, as described above, will be delivered 2–3 times per week during the maintenance phase. Content will emphasise behavioural strategies that promote long term adherence including autonomy, self-directed motivation and relapse prevention.