Cost-effectiveness of Exercise-based Rehabilitation Program Clinical Trial
Official title:
Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome
The objective of this multidisciplinary study is to employ health-economic evaluation in determining the health benefits achieved with exercise-based cardiac rehabilitation and the costs derived from it compared with conventional post-acute care of cardiac patients in the Finnish health care system.
The cost-effectiveness of exercise-based cardiac rehabilitation has not been systematically
studied earlier in Finland, and it is not justifiable to directly apply the results of
studies done in other countries to circumstances in Finland due to differences in the health
care and social security systems between the countries. The research will utilize top
Finnish expertise spanning clinical cardiology, health economics, and physical education.
The hypothesis is that a quality-adjusted life year of a cardiac patient (cost/QALY) is 20 %
less costly in a rehabilitation group than in a conventional post-acute care group.
The participants in the study will be recruited from Oulu University Hospital patients from
the Oulu region (n = 300) who have suffered acute coronary syndrome (angiographically
diagnosed coronary artery disease). Of these patients, 130 will be randomized to
exercise-based cardiac rehabilitation (Verve) and 170 to a control group. Dropping out of
the intervention will be mini-mized by means of careful definition of the inclusion criteria
and close follow-up. The rehabilitation will seek to implement the most recent international
recommendations for health-enhancing physical activity (% of those who achieved the exercise
target). Instructions for a progressive training model will be compiled. The amount of
exercise will be monitored objectively with a wrist-worn device based on wellness
technology. Subjective loading of both the training and health-enhancing physical activity
will be monitored using self-evaluation. The study will last one year for each patient,
after which cost-effectiveness will be analyzed (University of Eastern Finland). The results
of the research will facilitate decision making and choices in Finnish health care when
arranging rehabilitation for cardiac patients and planning the optimal utilization of health
care resources.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention