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

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.

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.

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.

Patient factors that influence clinicians' decision making in self-management support: A clinical vignette study.

BACKGROUND AND AIM: Self-management support is an integral part of current chronic care guidelines. The success of self-management interventions varies between individual patients, suggesting a need for tailored self-management support. Understanding the role of patient factors in the current decision making of health professionals can support future tailoring of self-management interventions. The aim of this study is to identify the relative importance of patient factors in health professionals' decision making regarding self-management support. METHOD: A factorial survey was presented to primary care physicians and nurses. The survey consisted of clinical vignettes (case descriptions), in which 11 patient factors were systematically varied. Each care provider received a set of 12 vignettes. For each vignette, they decided whether they would give this patient self-management support and whether they expected this support to be successful. The associations between respondent decisions and patient factors were explored using ordered logit regression. RESULTS: The survey was completed by 60 general practitioners and 80 nurses. Self-management support was unlikely to be provided in a third of the vignettes. The most important patient factor in the decision to provide self-management support as well as in the expectation that self-management support would be successful was motivation, followed by patient-provider relationship and illness perception. Other factors, such as depression or anxiety, education level, self-efficacy and social support, had a small impact on decisions. Disease, disease severity, knowledge of disease, and age were relatively unimportant factors. CONCLUSION: This is the first study to explore the relative importance of patient factors in decision making and the expectations regarding the provision of self-management support to chronic disease patients. By far, the most important factor considered was patient's motivation; unmotivated patients were less likely to receive self-management support. Future tailored interventions should incorporate strategies to enhance motivation in unmotivated patients. Furthermore, care providers should be better equipped to promote motivational change in their patients.