Abstract
BackgroundCoronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI) and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL), decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare) for depression and CHD secondary prevention, with Usual Care (UC).MethodsOver 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group). The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake), medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1), 6 months (post-intervention) (Time 2), 12 months (Time 3) and 24 months follow-up for longer term effects (Time 4). We are comparing depression (Cardiac Depression Scale [CDS]) and HRQOL (Short Form-12 [SF-12]) scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.DiscussionThis manuscript presents the protocol for a randomised, multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients. The results of this trial will provide valuable new information about potential psychological and wellbeing benefits, cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression.Trial Registration NumberAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000386235
Highlights
Coronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist
Coronary Heart Disease (CHD) and depression are currently two of the most important causes of disability in high-income countries [1] and it is projected that the same will apply to low and middle income countries by 2030 [2]. These conditions often co-exist with approximately 15% of Myocardial Infarction (MI) patients experiencing major depressive disorder (MDD) and another 15-20% exhibiting mild to moderate depression [3]
This paper presents the study protocol for a randomised, multi-centre, feasibility trial of a tele-health intervention for Acute Coronary Syndrome (ACS) patients with depression (’MoodCare’)
Summary
Coronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist. Coronary Heart Disease (CHD) and depression are currently two of the most important causes of disability in high-income countries [1] and it is projected that the same will apply to low and middle income countries by 2030 [2] These conditions often co-exist with approximately 15% of Myocardial Infarction (MI) patients experiencing major depressive disorder (MDD) and another 15-20% exhibiting mild to moderate depression [3]. Patients with post-MI depression are more likely to report impaired health related quality of life (HRQOL) [4], poorer medication adherence [5] and utilisation of health services [6], increased morbidity and suicide risk [7], and poorer CHD risk factor profiles, work outcomes [8] and survival [9]. Despite the high prevalence of depression following a diagnosis of CHD and the poor outcomes associated with the group [9], it remains poorly recognised and managed in CHD patients
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