Getting ‘Back on Track’ after a cardiac event: Protocol for a Randomised Controlled Trial of an online self-management program (Preprint)

BACKGROUND After a cardiac event, a large majority of cardiac patients do not achieve recommended behaviour change targets for secondary prevention. Mental health issues can also impact on the ability to engage in health behaviour change. There is a need for innovative, flexible and theory driven e-health programs which include evidence-based strategies to assist cardiac patients with their recovery, especially in behavioural and emotional self-management. OBJECTIVE The aim of this study is to determine the short and longer-term behavioural and emotional wellbeing outcomes of the Back on Track online self-management program. In addition, this study will test whether there is enhanced benefit of providing one-on-one telephone support from a trained lifestyle counsellor, over and above benefit obtained through completing the online program alone. METHODS People who have experienced a cardiac event in the previous 12 months and have access to the internet will be eligible for this study (N=120). Participants will be randomly assigned to one of the two study conditions: either ‘self-directed’ completion of the Back on Track program (without assistance), or ‘supported’ completion of the Back on Track program (additional two telephone sessions with a lifestyle counsellor). All participants will have access to the Back on Track online program for 2 months. Telephone sessions with the supported arm participants will occur at approximately 2- and 6-weeks post enrolment. Measures will be assessed at baseline, and then 2 and 6 months later. Outcome measures assessed at all three timepoints include dietary intake, physical activity and sitting time, smoking status, anxiety and depression, stage of change and self-efficacy in relation to behavioural and emotional self-management, quality of life and self-rated health and wellbeing. A demographic questionnaire will be included at baseline only and program acceptability at 2 months only. RESULTS Recruitment began in May 2020 and concluded in August 2021. Data collection for the 6-month follow-up will be completed by February 2022 and data analysis and publication of results will be complete by June 2022. A total of 122 participants were enrolled in this study. CONCLUSIONS The Back on Track trial will enable us to quantify the behavioural and emotional improvements obtained and maintained for cardiac patients and, in particular, to compare two modes of delivery – one fully self-directed and the other supported by a lifestyle counsellor. We anticipate that the Back on Track online program will assist patients in their recovery and self-management after an acute event, and represents an effective, flexible and easily accessible adjunct to centre-based rehabilitation programs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (Trial Registration Number: ACTRN12620000102976); http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378920&isReview=true