Getting "Back on Track" After a Cardiac Event: Protocol for a Randomized Controlled Trial of a Web-Based...

After a cardiac event, a large majority of patients with cardiac conditions do not achieve recommended behavior change targets for secondary prevention. Mental health issues can also impact the ability to engage in health behavior change. There is a need for innovative, flexible, and theory-driven eHealth programs, which include evidence-based strategies to assist patients with cardiac conditions with their recovery, especially in behavioral and emotional self-management.

The aim of this study is to determine the short- and longer-term behavioral and emotional well-being outcomes of the Back on Track web-based 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 counselor, over and above benefit obtained through completing the web-based program alone.

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 2 telephone sessions with a lifestyle counselor). All participants will have access to the web-based Back on Track program for 2 months. Telephone sessions with the supported arm participants will occur at approximately 2 and 6 weeks post enrollment. Measures will be assessed at baseline, and then 2 and 6 months later. Outcome measures assessed at all 3 timepoints include dietary intake, physical activity and sitting time, smoking status, anxiety and depression, stage of change, and self-efficacy in relation to behavioral and emotional self-management, quality of life, and self-rated health and well-being. A demographic questionnaire will be included at baseline only and program acceptability at 2 months only.

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 completed by June 2022. A total of 122 participants were enrolled in this study.

The Back on Track trial will enable us to quantify the behavioral and emotional improvements obtained and maintained for patients with cardiac conditions and, in particular, to compare two modes of delivery: (1) fully self-directed delivery and (2) supported by a lifestyle counselor. We anticipate that the web-based Back on Track program will assist patients in their recovery and self-management after an acute event, and represents an effective, flexible, and easily accessible adjunct to center-based rehabilitation programs.

Australian New Zealand Clinical Trials Registry ACTRN12620000102976; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378920&isReview=true.

DERR1-10.2196/34534.