Participant Flow. Chart must include initial engagement, eligibility determination, enrollment, active program participation/achievements and follow-up services. Flow charts shall indicate the movement of participants. Participant flow charts should include approximate time frames to move individuals through the system. For participants enrolled longer than one year, justification shall be submitted to the OCWIB for approval. CONTRACTOR shall provide the participant flow chart to the OCWIB administrative offices by July 31, 2014 for review and approval.
Participant Flow. A total of 437 consecutive patients were informed about the study by their physiotherapist three weeks before the end of the cardiac rehabilitation program. A total of 294 patients indicated that they were willing to participate, of whom 210 sent in an informed consent. Hereafter, 11 patients dropped-out due to work commitments (n=6), lack of time (n=3), and failing to provide a reason (n=2), leaving 199 patients who received the allocated intervention or control condition (a diagram showing the flow of the participants through each stage of the trial has been reported previously (5). Demographic and clinical characteristics have been described elsewhere (5), but in brief: the intervention group consisted of 80 men and 22 women versus 81 men and 15 women in the control group. The mean age was 56.6 (SD = 9.2) in the intervention group and 58.8 (SD = 9.3) in the control group. Main diagnoses included myocardial infarction, coronary artery bypass surgery and percutaneous coronary intervention. The majority of patients scored I or II on the NYHA functional capacity index. Mediation analysis The effect of the independent variable on the mediating variable (path a, Figure 1) was found to be significant, in that participation in the lifestyle intervention group predicted higher self-regulation scores at T2, after controlling for age, gender, cardiac history and NYHA-classification (B=.52, t=1.95, p=0.05). The effect of the mediating variable on the dependent variable (path b) was found to be significant, in that higher self-regulation scores at T2 were associated with greater physical activity at T3, controlling for physical activity at T1, participation in the lifestyle/control group, and the aforementioned control variables (B=278.44, t=2.17, p=0.03). The indirect effect (a x b) of the independent variable on the dependent variable through the mediator was also found to be significant; after adjusting for physical activity at T1 and age, gender, cardiac history and NYHA-classification, the lifestyle intervention program had a significant indirect effect on physical activity at T3 through self-regulation at T2 (point estimate = 144.22, 95% CI 8.42 to 329.32). Repeating the analyses without the covariates confirmed these results. Discussion At long-term follow-up, participation in the self-regulation lifestyle intervention was associated with higher levels of physical activity in post-CR patients. Furthermore, the lifestyle group reported improved SR skills as co...
