Cardiac rehabilitation is effective for secondary prevention of cardiac events and is endorsed by consensus guidelines but is limited by low enrollment and completion rates. Non-traditional delivery models that facilitate participation in CR are needed. The improving ATTENDance (iATTEND) to CR trial is an open label, single-site trial that compared standard facility-based only CR (FBCR) to hybrid CR (HYCR = patient-individualized combination of virtual CR delivered via synchronized telehealth and up to 12 in-facility CR sessions).
Qualifying patients enrolling into early outpatient CR were consented and randomized 1:1 to HYCR (n=142) or FBCR (n=140). Primary outcome was total number of CR sessions completed within 6 mo. Secondary outcomes were percent of patients completing all 36 prescribed CR sessions and changes (after CR – before CR) in exercise capacity (peak oxygen uptake, VO2; 6-minute walk distance, 6MWD). Both attendance outcomes (alpha set at p<0.05) and both exercise capacity outcomes [examined using the TOST (two, one sided tests) equivalence test] were adjusted for relevant, pre-specified co-variates.
Among patients enrolled into iATTEND (54% Black race, 33%; women, 34% > 65 yr), neither the total number of CR sessions completed per patient (28.7 + 11.8 vs 27.6 + 11.8 visits, adjusted p = 0.41) nor percent of patients completing 36 sessions (58.5 + 4.1 vs 50.7 + 4.2%, adjusted p=0.32) were different between HYCR and FBCR, respectively. After CR, changes in peak VO2 (mL.kg.-1min-1) were 2.3 + 2.8 vs 1.9 + 2.8 (HYCR and FBCR, respectively; adjusted p=0.78) and changes in 6MWD (m) were 46 + 46 vs 55 + 53 (HYCR and FBCR, respectively; adjusted p=0.18); TOST indicated equivalency (p=.001) between groups for both measures of change in exercise capacity. Across 7,735 total CR sessions, there was one major adverse event (non-fatal stroke within 3 hr after CR in HYCR) and no falls requiring medical attention.
In a diverse cohort of patients that included understudied groups, our data suggest that HYCR is an effective non-traditional model to deliver CR. When compared to standard FBCR, HYCR results in similar patient attendance patterns and equivalent improvements in exercise capacity. (Funded by: National Heart, Lung, and Blood Institute)