The use of virtual world-based cardiac rehabilitation to encourage healthy lifestyle choices among cardiac patients: intervention development and pilot study protocol.

BACKGROUND
Despite proven benefits through the secondary prevention of cardiovascular disease (CVD) and reduction of mortality, cardiac rehabilitation (CR) remains underutilized in cardiac patients. Underserved populations most affected by CVD including rural residents, low socioeconomic status patients, and racial/ethnic minorities have the lowest participation rates due to access barriers. Internet-and mobile-based lifestyle interventions have emerged as potential modalities to complement and increase accessibility to CR. An outpatient CR program using virtual world technology may provide an effective alternative to conventional CR by overcoming patient access limitations such as geographics, work schedule constraints, and transportation.

OBJECTIVE
The objective of this paper is to describe the research protocol of a two-phased, pilot study that will assess the feasibility (Phase 1) and comparative effectiveness (Phase 2) of a virtual world-based (Second Life) CR program as an extension of a conventional CR program in achieving healthy behavioral change among post-acute coronary syndrome (ACS) and post-percutaneous coronary intervention (PCI) patients. We hypothesize that virtual world CR users will improve behaviors (physical activity, diet, and smoking) to a greater degree than conventional CR participants.

METHODS
In Phase 1, we will recruit at least 10 patients enrolled in outpatient CR who were recently hospitalized for an ACS (unstable angina, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction) or who recently underwent elective PCI at Mayo Clinic Hospital, Rochester Campus in Rochester, MN with at least one modifiable, lifestyle risk factor target (sedentary lifestyle, unhealthy diet, and current smoking). Recruited patients will participate in a 12-week, virtual world health education program which will provide feedback on the feasibility, usability, and design of the intervention. During Phase 2, we will conduct a 2-arm, parallel group, single-center, randomized controlled trial (RCT). Patients will be randomized at a 1:1 ratio to adjunct virtual world-based CR with conventional CR or conventional CR only. The primary outcome is a composite including at least one of the following (1) at least 150 minutes of physical activity per week, (2) daily consumption of five or more fruits and vegetables, and (3) smoking cessation. Patients will be assessed at 3, 6, and 12 months.

RESULTS
The Phase 1 feasibility study is currently open for recruitment which will be followed by the Phase 2 RCT. The anticipated completion date for the study is May 2016.

CONCLUSIONS
While research on the use of virtual world technology in health programs is in its infancy, it offers unique advantages over current Web-based health interventions including social interactivity and active learning. It also increases accessibility to vulnerable populations who have higher burdens of CVD. This study will yield results on the effectiveness of a virtual world-based CR program as an innovative platform to influence healthy lifestyle behavior and self-efficacy.