Efficacy and Adherence Rates of a Novel Community‐Informed Virtual World‐Based Cardiac Rehabilitation Program: Protocol for the
Destination Cardiac Rehab
Randomized Controlled Trial
Background Innovative restructuring of cardiac rehabilitation (CR) delivery remains critical to reduce barriers and improve access to diverse populations. Destination Cardiac Rehab is a novel virtual world technology‐based CR program delivered through the virtual world platform, Second Life, which previously demonstrated high acceptability as an extension of traditional center‐based CR. This study aims to evaluate efficacy and adherence of the virtual world–based CR program compared with center‐based CR within a community‐informed, implementation science framework. Methods Using a noninferiority, hybrid type 1 effectiveness‐implementation, randomized controlled trial, 150 patients with an eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. Participants will be randomized 1:1 to either the 12‐week Destination Cardiac Rehab or the center‐based CR control groups. The primary efficacy outcome is a composite cardiovascular health score based on the American Heart Association Life's Essential 8 at 3 and 6 months. Adherence outcomes include CR session attendance and participation in exercise sessions. A diverse patient/caregiver/stakeholder advisory board was assembled to guide recruitment, implementation, and dissemination plans and to contextualize study findings. The institutional review board–approved randomized controlled trial will enroll and randomize patients to the intervention (or control group) in 3 consecutive waves/year over 3 years. The results will be published at data collection and analyses completion. Conclusions The Destination Cardiac Rehab randomized controlled trial tests an innovative and potentially scalable model to enhance CR participation and advance health equity. Our findings will inform the use of effective virtual CR programs to expand equitable access to diverse patient populations. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05897710.
Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini‐EAT (Eating Assessment Tool)
Background There is a scarcity of validated rapid dietary screening tools for patient use in the clinical setting to improve health and reduce cardiovascular risk. The Healthy Eating Index (HEI) 2015 measures compliance with the 2015 to 2020 Dietary Guidelines for Americans but requires completion of an extensive diet assessment to compute, which is time consuming and impractical. The authors hypothesize that a 19‐item dietary survey assessing consumption of common food groups known to affect health will be correlated with the HEI‐2015 assessed by a validated food frequency questionnaire and can be further reduced without affecting validity. Methods and Results A 19‐item Eating Assessment Tool (EAT) of common food groups was created through literature review and expert consensus. A cross‐sectional survey was then conducted in adult participants from a preventive cardiology clinic or cardiac rehabilitation and in healthy volunteers (n=661, mean age, 36 years; 76% women). Participants completed an online 156‐item food frequency questionnaire, which was used to calculate the HEI score using standard methods. The association between each EAT question and HEI group was analyzed by Kruskal‐Wallis test. Linear regression models were subsequently used to identify univariable and multivariable predictors for HEI score for further reduction in the number of items. The final 9‐item model of Mini‐EAT was validated by 5‐fold cross validation. The 19‐item EAT had a strong correlation with the HEI score ( r =0.73) and was subsequently reduced to the 9 items independently predictive of the HEI score: fruits, vegetables, whole grains, refined grains, fish or seafood, legumes/nuts/seeds, low‐fat dairy, high‐fat dairy, and sweets consumption, without affecting the predictive ability of the tool ( r =0.71). Conclusions Mini‐EAT is a 9‐item validated brief dietary screener that correlates well with a comprehensive food frequency questionnaire. Future studies to test the Mini‐EAT's validity in diverse populations and for development of clinical decision support systems to capture changes over time are needed.