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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.

DISCUSSION

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.

TRIAL REGISTRATION NUMBER

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000386235.

Authors+Show Affiliations

School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. adrienne.oneil@med.monash.edu.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21349204

Citation

O'Neil, Adrienne, et al. "A Randomised, Feasibility Trial of a Tele-health Intervention for Acute Coronary Syndrome Patients With Depression ('MoodCare'): Study Protocol." BMC Cardiovascular Disorders, vol. 11, 2011, p. 8.
O'Neil A, Hawkes AL, Chan B, et al. A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression ('MoodCare'): study protocol. BMC Cardiovasc Disord. 2011;11:8.
O'Neil, A., Hawkes, A. L., Chan, B., Sanderson, K., Forbes, A., Hollingsworth, B., ... Oldenburg, B. (2011). A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression ('MoodCare'): study protocol. BMC Cardiovascular Disorders, 11, p. 8. doi:10.1186/1471-2261-11-8.
O'Neil A, et al. A Randomised, Feasibility Trial of a Tele-health Intervention for Acute Coronary Syndrome Patients With Depression ('MoodCare'): Study Protocol. BMC Cardiovasc Disord. 2011 Feb 25;11:8. PubMed PMID: 21349204.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression ('MoodCare'): study protocol. AU - O'Neil,Adrienne, AU - Hawkes,Anna L, AU - Chan,Bianca, AU - Sanderson,Kristy, AU - Forbes,Andrew, AU - Hollingsworth,Bruce, AU - Atherton,John, AU - Hare,David L, AU - Jelinek,Michael, AU - Eadie,Kathy, AU - Taylor,C Barr, AU - Oldenburg,Brian, Y1 - 2011/02/25/ PY - 2011/02/04/received PY - 2011/02/25/accepted PY - 2011/2/26/entrez PY - 2011/2/26/pubmed PY - 2012/1/26/medline SP - 8 EP - 8 JF - BMC cardiovascular disorders JO - BMC Cardiovasc Disord VL - 11 N2 - 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. DISCUSSION: 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. TRIAL REGISTRATION NUMBER: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000386235. SN - 1471-2261 UR - https://www.unboundmedicine.com/medline/citation/21349204/A_randomised_feasibility_trial_of_a_tele_health_intervention_for_acute_coronary_syndrome_patients_with_depression__'MoodCare'_:_study_protocol_ L2 - https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/1471-2261-11-8 DB - PRIME DP - Unbound Medicine ER -