HEART: heart exercise and remote technologies: a randomized controlled trial study protocol.
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Date
2011-06-20
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Abstract
BACKGROUND Cardiovascular disease CVD is the leading cause of death worldwide Cardiac rehabilitation CR is aimed at improving health behaviors to slow or reverse the progression of CVD disease Exercise is a central element of CR Technologies such as mobile phones and the Internet mHealth offer potential to overcome many of the psychological physical and geographical barriers that have been associated with lack of participation in exercise based CR We aim to trial the effectiveness of a mobile phone delivered exercise based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD This paper outlines the rationale and methods of the trial METHODS A single blinded parallel two arm randomized controlled trial is being conducted A total of 170 people will be randomized at 1 1 ratio either to receive a mHealth CR program or usual care Participants are identified by CR nurses from two metropolitan hospitals in Auckland New Zealand through outpatient clinics and existing databases Consenting participants are contacted to attend a baseline assessment The intervention consists of a theory based personalized automated package of text and video message components via participants mobile phones and the Internet to increase exercise behavior delivered over six months The control group will continue with usual CR Data collection occurs at baseline and 24 weeks post intervention The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks Secondary outcomes include post intervention measures on self reported physical activity IPAQ cardiovascular risk factors systolic blood pressure weight and waist to hip ratio health related quality of life SF 36 and cost effectiveness DISCUSSION This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise based CR program Results of this trial will provide much needed information about physical and psychological well being and cost effectiveness of an automated telecommunication intervention If effective this intervention has enormous potential to improve the delivery of CR and could easily be scaled up to be delivered nationally and internationally in a very short time enhancing the translational aspect of this research It also has potential to extend to comprehensive CR nutrition advice smoking cessation medication adherence TRIAL REGISTRATION ACTRN12611000117910
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Keywords
At risk for a particular disease or infection, Client, Access to information or data, Geographic inaccessibility, Low adherence to treatments, Pilot, Randomized, Cardiovascular disease, Non-communicable diseases, Chronic care, Health education or promotion, Treatment adherence, Disease management, Text, Video