title: A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression ('MoodCare'): study protocol.
abstract: BACKGROUND
  Coronary 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).
  
  
  METHODS
  Over 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000386235.
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. adrienne.oneil@med.monash.edu.au
authors.forename: Adrienne
authors.initials: A
authors.lastname: O'Neil
authors.forename: Anna L
authors.initials: AL
authors.lastname: Hawkes
authors.forename: Bianca
authors.initials: B
authors.lastname: Chan
authors.forename: Kristy
authors.initials: K
authors.lastname: Sanderson
authors.forename: Andrew
authors.initials: A
authors.lastname: Forbes
authors.forename: Bruce
authors.initials: B
authors.lastname: Hollingsworth
authors.forename: John
authors.initials: J
authors.lastname: Atherton
authors.forename: David L
authors.initials: DL
authors.lastname: Hare
authors.forename: Michael
authors.initials: M
authors.lastname: Jelinek
authors.forename: Kathy
authors.initials: K
authors.lastname: Eadie
authors.forename: C Barr
authors.initials: CB
authors.lastname: Taylor
authors.forename: Brian
authors.initials: B
authors.lastname: Oldenburg
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications / Q000523:psychology / Q000628:therapy*; D000328:Adult; D000339:Affect; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003866:Depressive Disorder / Q000150:complications / Q000523:psychology / Q000628:therapy*; D005240:Feasibility Studies; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D017216:Telemedicine / Q000379:methods*; D055815:Young Adult