NCT02725203

Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients

Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients With a Cardiovascular Risk: a Clustered-randomized Controlled Trial in Primary Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Activate	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

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-03-31
• Last updated: 2018-10-18

Locations

31 sites across 1 country: Netherlands