Analysis of the psychological impact of a vascular risk factor intervention: results from a cluster randomized controlled trial in Australian general practice

BACKGROUND Screening for vascular disease, risk assessment and management are encouraged in general practice however there is limited evidence about the emotional impact on patients. The Health Improvement and Prevention Study evaluated the impact of a general practice-based vascular risk factor intervention on behavioural and physiological risk factors in 30 Australian practices. The primary aim of this analysis is to investigate the psychological impact of participating in the intervention arm of the trial. The secondary aim is to identify the mediating effects of changes in behavioural risk factors or BMI. METHODS This study is an analysis of a secondary outcome from a cluster randomized controlled trial. Patients, aged 40-65 years, were randomly selected from practice records. Those with pre-existing cardiovascular disease were excluded. Socio-demographic details, behavioural risk factors and psychological distress were measured at baseline and 12 months. The Kessler Psychological Distress Score (K10) was the outcome measure for multi-level, multivariable analysis and a product-of-coefficient test to assess the mediating effects of behaviour change. RESULTS Baseline data were available 384 participants in the intervention group and 315 in the control group. Twelve month data were available for 355 in the intervention group and 300 in the control group. The K10 score of patients in the intervention group (14.78, SD 5.74) was lower at 12 months compared to the control group (15.97, SD 6.30). K10 at 12 months was significantly associated with the score at baseline and being unable to work but not with age, gender, change in behavioural risk factors or change in BMI. CONCLUSIONS The reduction of K10 in the intervention group demonstrates that a general practice based intervention to identify and manage vascular risk factors did not adversely impact on the psychological distress of the participants. The impact of the intervention on distress was not mediated by a change in the behavioural risk factors or BMI, suggesting that there must be other mediators that might explain the positive impact of the intervention on emotional wellbeing. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12607000423415.