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

Heleen Westland, Irene D Bos-Touwen, Jaap C A Trappenburg, Carin D Schröder, Niek J de Wit, Marieke J Schuurmans, Heleen Westland, Irene D Bos-Touwen, Jaap C A Trappenburg, Carin D Schröder, Niek J de Wit, Marieke J Schuurmans

Abstract

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.

Trial registration: ClinicalTrials.gov identifier: NCT02725203 . Registered on 25 March 2016.

Keywords: Behaviour change techniques; Behaviour change wheel; Cardiovascular risk management; Cluster RCT; Nurse-led; Physical activity; Primary care; Self-management.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) diagram [65] for the Activate intervention showing participant flow through each stage of the randomised trial
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. Abbreviations: Q Questionnaire, C Chart review, SQUASH Short Questionnaire to Assess Health, HLS-EU-Q European Health Literacy Survey Questionnaire, MSPSS Multidimensional Scale of Perceived Social Support, HADS Hospital Anxiety and Depression Scale, CAT Communication Assessment Tool, CVRM Cardiovascular risk management, ESS Exercise Self-efficacy Scale, PAM-13 Patient Activation Measure short form, DM2 diabetes mellitus type 2, BMI Body mass index, HbA1c Glycated haemoglobin
Fig. 3
Fig. 3
The Behaviour Change Wheel and Theoretical Domains Framework (TDF) domains. Reprinted with permission from Michie et al. [36, 37]

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