Background
Striking the balance in 24-hour movement behaviour (24h MB: sedentary behaviour, physical activity and sleep) is expected to reduce the risk of recurrent major cardiovascular event or death (MACE). We aim to determine the (cost-)effectiveness of the RISE intervention for secondary prevention of MACE in community dwelling people at risk with first-ever stroke by improving 24h MB.
Methods
This assessor-blinded multicenter randomized controlled trial includes 1000 participants with first-ever stroke, of whom 752 are high-risk participants (who are sedentary and inactive based on their 24-hour MB) and randomized to the experimental group (RISE intervention) or control (usual care) group. RISE is a 15 week-blended behavioral intervention: 120 primary care physiotherapists coach people in their home setting using behaviour change techniques and the RISE eCoaching system. This system consists of 1) an activity monitor, 2) a smartphone application that provides real-time feedback and contains e-learning modules, and 3) a monitoring dashboard for the physiotherapist. A close relative is involved during the intervention to provide participatory support. This intervention was co-designed with stroke survivors.
The primary outcome is effectiveness of the RISE intervention regarding prevention of MACE measured at one year post-randomization. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24h MB over time.
Conclusion
The integration of behaviour change techniques, the RISE eCoaching system, participatory support, and extensively trained physiotherapists is expected to establish a sustainable movement behaviourial change and thereby contribute to the prevention of MACE. This will offer a foundation for implementation in post-stroke care.