Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      A two-armed, cluster randomized controlled trial will be conducted comparing the Activate
      intervention with care as usual in 31 general practices in the Netherlands, in which
      approximately 279 patients at risk for cardiovascular disease will participate. The Activate
      intervention focuses on increasing physical activity and is developed using the Behavior
      Change Wheel (BCW). The activate intervention consists of four nurse-led consultations
      divided over a 3-months period. Primary outcome is the level of physical activity measured
      with an accelerometer. Potential effect modifiers are age, body mass index, level of
      education, social support, depression, patient-provider relationship and baseline amount of
      minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months
      of follow up.

      Nurses will be trained in delivering the intervention by a one-day training and coaching
      sessions supervised. A process evaluation will be conducted.
    

Detailed description: 
      Self-management interventions are considered effective in chronic disease patients, but
      trials have shown inconsistent results and it is unknown which patients benefit most.
      Adequate self-management requires behaviour change in patients and in healthcare providers to
      equip them in supporting patients in changing their behaviour. To unravel effectiveness of
      self-management, a nurse-led intervention was developed targeting at one self-management
      behaviour, namely physical activity, in primary care patients at risk for cardiovascular
      disease: the Activate intervention. This study aims to evaluate the effectiveness of the
      Activate intervention, to identify which patient-related characteristics modify change in
      physical activity levels in patients at risk for CVD in primary care, and to conduct a
      process evaluation.

      A two-armed, cluster randomized controlled trial will be conducted comparing the Activate
      intervention with care as usual in 31 general practices in the Netherlands, in which
      approximately 300 patients at risk for cardiovascular disease will participate. The Activate
      intervention focuses on increasing physical activity and is developed using the Behavior
      Change Wheel (BCW). The activate intervention consists of four nurse-led consultations
      divided over a 3-months period in which 17 behaviour change techniques (BCTs) are integrated.
      Primary outcome is the level of physical activity measured with an accelerometer . Potential
      effect modifiers are age, body mass index, level of education, social support, depression,
      patient-provider relationship and baseline amount of minutes of physical activity. Data will
      be collected at baseline, at 3 months and at 6 months of follow up.

      Subsequently, the BCW was applied to analyse what behavior change is needed in nurses to
      deliver the Activate intervention adequately. This resulted in a one-day training and
      coaching sessions supervised by a health psychologist and included 21 BCT.

      A process evaluation will be conducted to evaluate the training of nurses, fidelity, dose and
      reach of the Activate intervention, identify barriers and facilitators for implementation and
      to assess participants' satisfaction.
    

Intervention name(s): Activate
Intervention type(s): Behavioral
Intervention description(s): The Activate intervention consists of four nurse-led consultations in a thee-month period. In the consultations patients receive structured and comprehensive support in achieving an improved level of physical activity. The Behavior Change Wheel was used to develop the Activate intervention, and led to a selection of 17 behavior change techniques, which are integrated in the Activate intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cardiovascular risk management; behaviour change techniques; self-management; physical activity; nurse-led; behaviour change wheel; primary care; clustered RCT