Abstract
BackgroundCardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay.Methods/DesignA parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters.DiscussionThe study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority.Trial registrationTrial registry http://www.clinicaltrials.gov: NCT01223170.
Highlights
Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity
This study suggests a new approach in supporting the self-management of Cardiovascular diseases (CVD) patients after rehabilitation
We propose to combine and extend this research in line with the Health Action Process Approach Health action process approach (HAPA) [25], through tailoring to different selfefficacies according to where the individual are in their process of change
Summary
The intervention suggested in this protocol is utilizing longitudinal tailoring based on models of health behaviour combined in a way that, to the best of our knowledge, have not been tested before. The intervention is based on models of health behaviour that to a large extent have been tested independently in other eHealth interventions but – to our knowledge – it is the first time they are combined. Another strength of our study is the level of the user-involvement in the design of the intervention. Contribution and future studies This project addresses one of the major health issues in the world, CVD, and aims to contribute to the empirical as well as theoretical basis for developing effective Internet and mobile phone based primary and secondary preventive interventions with high reach.
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