Effectiveness of the nurse-led Activate intervention in patients at risk of cardiovascular disease in primary care: a cluster-randomised controlled trial

Heleen Westland, Marieke J Schuurmans, Irene D Bos-Touwen, Marjolein A de Bruin-van Leersum, Evelyn M Monninkhof, Carin D Schröder, Daphne A de Vette, Jaap Ca Trappenburg, Heleen Westland, Marieke J Schuurmans, Irene D Bos-Touwen, Marjolein A de Bruin-van Leersum, Evelyn M Monninkhof, Carin D Schröder, Daphne A de Vette, Jaap Ca Trappenburg

Abstract

Background: To understand better the success of self-management interventions and to enable tailoring of such interventions at specific subgroups of patients, the nurse-led Activate intervention is developed targeting one component of self-management (physical activity) in a heterogeneous subgroup (patients at risk of cardiovascular disease) in Dutch primary care.

Aim: The aim of this study was to evaluate the effectiveness of the Activate intervention and identifying which patient-related characteristics modify the effect.

Methods: A two-armed cluster-randomised controlled trial was conducted comparing the intervention with care as usual. The intervention consisted of four nurse-led behaviour change consultations within a 3-month period. Data were collected at baseline, 3 months and 6 months. Primary outcome was the daily amount of moderate to vigorous physical activity at 6 months. Secondary outcomes included sedentary behaviour, self-efficacy for physical activity, patient activation for self-management and health status. Prespecified effect modifiers were age, body mass index, level of education, social support, depression, patient provider relationship and baseline physical activity.

Results: Thirty-one general practices (n = 195 patients) were included (intervention group n = 93; control group n = 102). No significant between-group difference was found for physical activity (mean difference 2.49 minutes; 95% confidence interval -2.1; 7.1; P = 0.28) and secondary outcomes. Patients with low perceived social support (P = 0.01) and patients with a low baseline activity level (P = 0.02) benefitted more from the intervention.

Conclusion: The Activate intervention did not improve patients' physical activity and secondary outcomes in primary care patients at risk of cardiovascular disease. To understand the results, the intervention fidelity and active components for effective self-management require further investigation.Trial registration: ClinicalTrials.gov NCT02725203.

Keywords: Behaviour change wheel; cluster-randomised controlled trial; nurse-led intervention; physical activity; primary care; self-management.

Conflict of interest statement

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Study design of the Activate cluster-randomised controlled trial.
Figure 2.
Figure 2.
CONSORT flowchart of general practices and participants assigned to the intervention and control group. *Data available for at least 4 week days and one weekend day for 8 hours.
Figure 3.
Figure 3.
Estimated means of the multidimensional scale of perceived social support.
Figure 4.
Figure 4.
Estimated means of baseline physical activity.

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