Women’s Health Behaviours Following Referral to 3 Different Cardiac Rehabilitation Program Models: A Randomized Controlled Trial Put your Title here clinicaltrials.gov Registration #NCT01019135 L Midence, MSc1; HM Arthur, PhD2; P Oh, MD3; S Brister, MD3; C Chessex, MD3; DE Stewart, MD3; SL Grace, PhD1, 3 1York University, 2Hamilton Health Sciences Centre, 3University Health Network - Ontario, Canada BACKGROUND CVD is the leading cause of death globally Cardiac rehabilitation (CR) participation is associated with significantly lower morbidity and mortality, Benefits are due to, among other factors, adherence to a heart-healthy lifestyle New models of CR have been developed, such as women-only programs, to better meet their needs OBJECTIVE To test whether participation in women-only CR results in significantly better health behaviours when compared to participation in co-ed or home-based CR. RESULTS Participant Characteristics by Post-Program Survey Retention Medication Adherence by Randomized Model Excluded n=1847 (91.6%) Declined n=739 (40.0%) INELIGIBLE: Lives and works too far from CR sites n=375 (20.3%) Does not speak/read English n=196 (10.6%) No cardiac diagnosis or procedure meeting inclusion criteria n=162 (8.8%) Referral to CR program prior to randomization n=100 (5.4%) Musculoskeletal, neuromuscular, vision, cognitive or non-dysphoric psychiatric condition/too ill n=86 (4.6%) Not eligible for home-based CR n=68 (3.7%) Recent participation in CR n=25 (1.4%) Planning to leave the province n=23 (1.2%) Did not consent to randomization n=20 (1.1%) Discharged to long-term care n=17 (1.0%) Enrolled in other study with behavioral intervention n=8 (0.4%) Patient passed away n=5 (0.3%) Physician clearance not received n=5 (0.3%) Other n=18 (1.0%) Allocation Enrollment Randomized n=169 (8.4%) Assessed for eligibility n= 2016 Analysis Returned T2 survey=38 (69.1%) Returned T2 pedometer=21 (38.2%) Returned T2 survey=36 (65.5%) Returned T2 pedometer=19 (34.5%) Follow-Up Returned T2 survey=42 (71.2%) Returned T2 pedometer=15 (25.4%) Women-only n=55 (32.5%) Received allocated intervention n=35 (63.6%) Did not receive allocated intervention n= 14 (25.4%) Did not attend n=5 (9.1%) Home-based n=55 (32.5%) Received allocated intervention n=24 (43.6%) Did not receive allocated intervention n= 25 (45.5%) Did not attend n=6 (10.9%) Mixed-sex n=59 (34.9%) Received allocated intervention n=39 (66.1%) Did not receive allocated intervention n=6 (10.2%) Did not attend n=14 (23.7%) Analysed survey n=38 (4 excluded due to no T1 survey) Analysed pedometer n=11 (4 excluded due to no T1 pedometer) Analysed survey n=32 Analysed pedometer n=12 (7 excluded due to no T1 pedometer) Analysed survey n=35 (3 excluded due to no T1 survey) Analysed pedometer n=15 (6 excluded due to no T1 pedometer) Characteristics Returned T2 survey Lost to follow-up Total n=116 (68.6%) n=53 (31.4%) n = 169 Sociodemographic Age, years (mean ± SD) 64.79 ± 9.57 61.10 ± 11.80 63.64 ± 10.42* Marital Status, n (% married) 50 (47.6%) 22 (56.4%) 72 (50.0%) Work Status, n (% retired) 56 (53.3%) 16 (41.0%) Ethnicity, n (% white) 65 (61.9%) 25 (64.1%) 90 (62.5%) Education, n (% post-secondary) 40 (38.1%) 14 (35.9%) 54 (37.5%) Gross Annual Family Income (% <$50,000 CDN) 58 (55.2%) 28 (71.8%) 86 (59.7%) Provide care to someone in household, n (% yes) 6 (9.1%) 10 (37%) 16 (17.2%)** Have children, n (% yes) 88 (85.4%) 32 (84.2%) 120 (85.1%) Clinical Indication for CR PCI (% yes) 56 (49.1%) 25 (49.0%) 81 (49.1%) Angina/ACS/CAD (% yes) 37 (33.0%) 22 (43.1%) 59 (36.2%) MI (% yes) 40 (35.4%) 19 (36.5%) 59 (35.8%) CABG (% yes) 29 (25.4%) 13 (25.5%) 42 (25.5%) Valve (% yes) 26 (23.0%) 6 (11.5%) 32 (19.4%) Risk Factors Dyslipidemia (% yes) 70 (84.3%) 34 (81.0%) 104 (83.2%) Hypertension (% yes) 68 (73.1%) 33 (80.5%) 101 (75.4%) Obesity 35 (44.9%) 14 (36.8%) 49 (42.2%) Diabetes 23 (28.8%) 15 (42.9%) 38 (33.0%) Comorbidities Musculoskeletal Impairment (% yes) 14 (15.9%) 6 (13.6%) 20 (15.2%) Depression (% yes) 10 (11.4%) 5 (11.6%) 15 (11.5%) Cancer (% yes) 6 (6.7%) 2 (4.9%) 8 (6.2%) Hyperthyroid (% yes) 4 (4.5%) 2 (4.8%) 6 (4.6%) Renal Disease (% yes) 2 (2.3%) 4 (3.1%) PAD/PVD (% yes) 1 (1.1%) 1 (2.4%) 2 (1.5%) Liver Disease (% yes) 0 (0.0%) 1 (0.8%) Intake Assessment Resting Heart Rate (BPM) 75.15 ± 14.80 76.38 ± 15.73 75.54 ± 15.06 Waist Circumference (cm) 92.53 ± 12.95 97.28 ± 16.42 94.15 ± 14.34 Peak METS 5.16 ± 2.08 4.73 ± 1.76 5.03 ± 1.99 Peak VO2 (mL/(kg•min) 18.10 ± 7.29 16.59 ± 6.17 17.62 ± 6.97 ANCOVA adjusted for baseline adherence, age and caregiving (p=.62); mean MMA score ± standard deviation where >2 indicates adherent patients DESIGN Single-blind, 3 parallel-arm ,pragmatic randomized controlled trial, with 1:1:1 allocation concealed. Female patients were randomized to 1 of 3 CR models at closest of 3 sites The randomization sequence was computer-generated, in blocks of 6, and stratified by cardiac condition. METHODS Low-risk female coronary artery disease patients were recruited from 6 inpatient and outpatient cardiac settings in the Greater Toronto Area of Ontario, Canada. Consenting participants completed a pre-program survey assessing health behaviours: Godin – self-reported physical activity Diet Habit Survey – eating habits Morisky – medication adherence Investigator-generated item – smoking behaviour Also wore a pedometer for 7 days Six months later participants were mailed a follow-up survey, and again wore a pedometer Pre-specified secondary objective of trial FINDINGS Patients walked over 6500 steps/day, were highly active, consumed low-fat diet, and were highly adherent to their medications (even pre- CR) There were few smokers (n=8; 4.7%) Overall there was a significant increase in self- reported PA pre to post CR (p<.001) There was a trend towards improved overall diet pre to post-program (p=.09). In the “intention-to-treat” analyses, there were no significant differences in any health behaviours by model (see Figs) LIMITATIONS: Potential selection bias – low-risk participants, interested in exercise Generalizability – other health care systems CONCLUSIONS Women’s health behaviours were either excellent pre-CR or significantly improved during CR, no matter which program model they participated in. 19 (11.7%) participants did not enroll in CR, and 43 (25.4%) attended a different model than the program to which they were randomly-allocated. *Denotes significant difference between pre and post-CR measures using t-tests or chi-squares p<.05; **p<.01; ***p<.001). Pedometer Step Count by Randomized Model Self-Reported Physical Activity by Randomized Model Diet Score by Randomized Model ANCOVA adjusted for baseline diet, age and caregiving (p=.51); mean DHS score ± standard deviation where >6500 is equivalent to 191-235 ≈ 25% fat diet ANCOVA adjusted for baseline steps, age, incidence of valve surgery, and intake peak VO2 values (p=.98); mean steps± standard deviation, where >6500 is equivalent to ~150 min MVPA/week ANCOVA adjusted for baseline Godin, age and caregiving (p=.42); mean Godin score ± standard deviation where >20 is equivalent to high PA