Open AccessEffectiveness of the nurse-led Activate intervention in patients at risk of cardiovascular disease in primary care: a cluster-randomised controlled trial
Author(s) -
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 C.A. Trappenburg
Publication year - 2020
Publication title -
european journal of cardiovascular nursing
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.914
H-Index - 50
eISSN - 1873-1953
pISSN - 1474-5151
DOI - 10.1177/1474515120919547
Subject(s) - medicine , psychological intervention , intervention (counseling) , physical therapy , randomized controlled trial , depression (economics) , cluster randomised controlled trial , confidence interval , body mass index , cluster (spacecraft) , disease , relative risk , social support , clinical trial , nursing , psychology , computer science , programming language , economics , psychotherapist , macroeconomics
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.