A multisite, randomised, controlled, single-blind trial of a personalised digital health intervention for post-discharge cardiology patients

Study A (Effectivness Testing): Study A is an individually-randomised trial comprised of two parallel arms (i.e. Treatment and Control arms). The digital health intervention (DHI) comprises a 6-month program of education, support and guidance customised to patients’ cardiovascular condition, socio-demographics and preferences and delivered primarily via text-messages and complimented with multi-channel digital communication (via App, web-links, email). The DHI program is designed to support patients who have had a cardiovascular hospitalisation after being discharged. The program content aims to provide information, support and a line of connection for patients to healthcare providers for 6 months. These will encourage patients to optimise their cardiovascular risk factor control, adhere to their treatments, follow-up with their healthcare providers and improve their self-efficacy in managing their cardiovascular health. The content will be aligned with clinical guidelines, approved by clinicians and localised to local services and community. Participants will receive up to 5 messages a week for 26 weeks. Content areas include: General heart health, smoking cessation, diet & nutrition, physical activity, coronary heart disease, heart failure, atrial fibrillation, implated cardiac devices. Each text message is less than 300 characters with some messages containing links to additional information which is optional to review. A brief example of content that may be shared is: "After a heart heart attack, most people are prescribed two antiplatelet medicines. This is aspirin plus one other blood thinning medicine. Both are very important to prevent the blood vessel from blocking up again. Speak to your doctor for more info." Study B (Implementation Testing): At the outset, all participants enrolled in Study A will also be enrolled in Study B. Study B is a cluster crossover trial (where each site comprises a cluster) that will test whether an additional pone call improves participant recruitment to join the DHI program described above (Study A). Clusters are randomised to one of 2 sequences (each lasting 12 weeks): Sequence 1 (Treatment period [6 weeks] followed by Control Period [6 weeks]), OR Sequence 2 (Control Period [6 weeks] followed by Treatment period [6 weeks]). Study A and Study B will begin simultaneously. All patients (both Study B Control and Treatment groups) being discharged from cardiovascular services will receive a text message and SMS reminders soon after leaving the hospital. These will be about the digital discharge support program provided by the Cardiology department of the relevant hospital. In addition to these, participants recruited during Study B’s Treatment Period will also receive a telephone call within a week of discharge, detailing the program. If the patient is not contactable, the staff member responsible will attempt to call them a total of three times in the ensuing week following the first call. During this telephone call with a study staff member, participants will be offered the option to consent over the phone, stepped through the consent process and multi-factor verification for program enrolment and asked to answer a few additional questions to customise the content. We will assess adherence through self-report and interaction with digital platform including engagement metrics.