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Randomized Controlled Trial
. 2013 Dec 13:14:190.
doi: 10.1186/1471-2296-14-190.

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

Suzanne Helen McKenzie  1 , Upali W Jayasinghe, Mahnaz Fanaian, Megan Passey, Mark Fort Harris
Affiliations
Randomized Controlled Trial

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

Suzanne Helen McKenzie et al. BMC Fam Pract. .

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.

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Figures

Figure 1
Figure 1
Participant recruitment, flow and follow-up.
See this image and copyright information in PMC

References

    1. Britt H, Miller GC, Charles J, Henderson J, Bayram C, Pan Y, Valenti L, Harrison C, Fahridin S, O’Halloran J. General practice activity in Australia, 2008–09. General practice series no. 25. GEP 25. Canberra: AIHW; 2009. [ http://www.aihw.gov.au/publication-detail/?id=6442468308] Accessed July 2012.
    1. Eriksson MK, Franks PW, Eliasson M. A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study. PloS One. 2009;14:e5195. doi: 10.1371/journal.pone.0005195. - DOI - PMC - PubMed
    1. Ebrahim S, Beswick A, Burke M, Davey Smith G. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2006. p. CD001561. doi:10.1002/14651858.CD001561.pub3. - PMC - PubMed
    1. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M. for the Finnish Diabetes Prevention Study, Group. Prevention of Type 2 diabetes melllitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;14:1343–1350. doi: 10.1056/NEJM200105033441801. - DOI - PubMed
    1. Royal Australian College of General Practitioners. Guidelines for preventive activities in general practice. 8. East Melbourne; 2012. [ http://www.racgp.org.au/download/Documents/Guidelines/Redbook8/redbook8.pdf] Accessed November 2012.

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