Background: Self-management interventions are considered effective in patients with chronic disease, but trials
have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management
requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was
developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a
single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular
disease. The aim of this study is to evaluate the effectiveness of the Activate intervention.
Methods/design: A two-arm cluster randomised controlled trial will be conducted to compare the Activate
intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for
cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel
and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The
Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the
intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change
techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous
physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education,
social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data
will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted
to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as
well as to assess participants’ satisfaction.
Discussion: To increase physical activity in patients and to support nurses in delivering the intervention, behaviour
change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of
the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for
primary care nurses will enhance understanding of what works and for whom, which is essential for further
implementation of self-management in clinical practice.