Norwegian Centre for Integrated Care and Telemedicine, University Hospital of North Norway, Tromsø, N-9038, Norway.
BMC Cardiovasc Disord. 2012 Jul 9;12:50. doi: 10.1186/1471-2261-12-50.
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. 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/DESIGN: A 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.
The 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 registry http://www.clinicaltrials.gov: NCT01223170.
心脏康复对于心血管疾病的恢复和二级预防非常重要，其主要策略之一是提高身体活动水平。基于互联网和移动电话的干预措施已成功用于帮助人们实现这一目标。这些干预措施的疗效相关的一个组成部分是针对个体定制内容。本试验正在研究基于健康行为模型的纵向定制的基于互联网和移动电话的干预措施对身体活动水平和对干预措施的依从性的影响，作为面对面心脏康复的延伸。
方法/设计：一项平行组、集群随机对照试验。研究人群为挪威心脏康复计划中的成年参与者，他们在家中可以使用互联网和移动电话，每月按集群随机分为对照组或干预组。参与者可以访问一个包含心脏康复信息的网站、一个在线讨论论坛和一个在线活动日历。随机分配到干预组的参与者还将收到基于健康行为模型的个性化内容，通过网站和移动短信提供。该试验的目的是评估干预措施对康复治疗结束后自我管理行为的维持效果。主要结局是心脏康复计划结束后一个月、三个月和一年的身体活动水平。集群的随机分配是基于在线真实随机数服务，参与者、研究人员和结果评估者对集群的情况均不知情。
该研究提出了一种基于理论的干预措施，将健康行为模型以创新的方式结合在一起，以定制所提供的内容。用户积极参与了该干预措施的设计，并且由于使用了开源软件，该干预措施可以方便且低成本地被他人复制和扩展。挑战在于在老年人群中进行招募，以及研究样本中女性可能代表性不足。该研究由挪威北部地区卫生局资助。
