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

McKenzie, Suzanne Helen , Jayasinghe, Upali W., Fanaian, Mahnaz, Passey, Megan, and Harris, Mark Fort (2013) Analysis of the psychological impact of a vascular risk factor intervention: results from a cluster randomized controlled trial in Australian general practice. BMC Family Practice, 14. 190. pp. 1-8.

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Abstract

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.

Item ID: 31463
Item Type: Article (Research - C1)
ISSN: 1471-2296
Additional Information:

© 2013 McKenzie et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Funders: National Health and Medical Research Council of Australia (NHMRC)
Projects and Grants: NHMRC project grant 455268
Date Deposited: 18 Mar 2014 05:49
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111717 Primary Health Care @ 100%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920103 Cardiovascular System and Diseases @ 100%
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