Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial

Abstract

BackgroundSelf-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/designA 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.DiscussionTo 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.Trial registrationClinicalTrials.gov identifier: NCT02725203. Registered on 25 March 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1823-9) contains supplementary material, which is available to authorized users.

Fidelity of primary care nurses’ delivery of a behaviour change intervention to enhance physical activity in chronic patients

“…Accordingly, parallel to the evaluation of the effectiveness of a behaviour change intervention (the Activate intervention) in a cluster-randomised controlled trial comparing the Activate intervention to care as usual, we planned to evaluate the intervention delity. The Activate intervention is a nurse-led behaviour change intervention to enhance physical activity in primary care patients at risk for cardiovascular disease (CVD) [11]. In the trial, 195 patients of 31 general practices throughout the Netherlands participated.…”

“…Prior conducted process evaluation covered the delity dimensions study and intervention design, provider training, treatment receipt and enactment of treatment skills [11,13,14]. The evaluation of the intervention design showed that the use of the Behaviour Change Wheel [15], as theoretical framework for developing the Activate intervention and use of a cluster-RCT design allowed for addressing the research questions [11].…”

“…Prior conducted process evaluation covered the delity dimensions study and intervention design, provider training, treatment receipt and enactment of treatment skills [11,13,14]. The evaluation of the intervention design showed that the use of the Behaviour Change Wheel [15], as theoretical framework for developing the Activate intervention and use of a cluster-RCT design allowed for addressing the research questions [11]. The evaluation of the provider training showed that the standardised comprehensive training programme for nurses facilitated nurses to acquire essential competences to deliver the intervention, although adopting these competences was challenging [11,13].…”

“…The evaluation of the intervention design showed that the use of the Behaviour Change Wheel [15], as theoretical framework for developing the Activate intervention and use of a cluster-RCT design allowed for addressing the research questions [11]. The evaluation of the provider training showed that the standardised comprehensive training programme for nurses facilitated nurses to acquire essential competences to deliver the intervention, although adopting these competences was challenging [11,13]. Moreover, the evaluation of the treatment receipt and enactment showed that patients understood the intervention and used taught skills well and patients performed the intervention and taught skills in their daily lives [14].…”

Clinician perception of a novel cardiovascular lifestyle prescription form in the primary and secondary care setting in Wales, UK

“…Behaviour change is a sustained process, which, if it is to be successfully initiated, necessitates a positive relationship between the provider (counsellor or practitioner) and the client (patient), built on trust and effective communication . Patients trust and appreciate the significance of prescription forms issued to them by their consulting clinician .…”