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Updated: Feb 7, 2026
In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a
Malcolm Battersby1,2, Michael R Kidd3,4, Julio Licinio5
1Mental Health Services, Southern Adelaide Local Health Network (SAHLN), Margaret Tobin Centre, Bedford Park, South Australia, 5042, Australia.
Insights
People with severe mental illness (SMI) face reduced life expectancy due to physical health issues like cardiovascular disease (CVD). This study tests an intervention to lower CVD risk and improve quality of life (QoL) in this population.
Area of Science:
- Public Health
- Clinical Psychology
- Health Economics
Background:
- Adults with severe mental illness (SMI) in Australia experience significantly reduced life expectancy, primarily due to physical health comorbidities, especially cardiovascular disease (CVD).
- High rates of modifiable CVD risk factors (hypertension, smoking, dyslipidemia, diabetes, obesity) contribute to reduced quality of life (QoL) and early mortality in people with SMI.
- Current delivery of recommended physical health monitoring and risk reduction for people with SMI is inadequate, necessitating effective preventive interventions.
Purpose of the Study:
- To evaluate the effectiveness and health economics of a chronic condition management (CCM) intervention designed to reduce CVD risk and improve QoL in adults with SMI.
- To identify essential components, enablers, and barriers for the national, sustained implementation of recommended physical health care for people with SMI.
Main Methods:
- A rigorous, piloted intervention integrating the Flinders Program's psychosocial care planning approach was developed.
- The intervention focuses on patient-centered care, self-management capacity building, and a collaborative, recovery-oriented framework.
- Participants were recruited from a community-based public psychiatric service for this trial.
Main Results:
- The study aims to reduce CVD risk by 20% through a combination of standardized and flexible motivational processes with evidence-based interventions.
- Primary outcome measures focus on assessing changes in CVD risk and QoL.
- The trial will provide data on the feasibility and impact of the CCM intervention in a real-world clinical setting.
Conclusions:
- This is the first large-scale global trial utilizing the Flinders Program for individuals with SMI to address physical health comorbidities.
- Successful implementation could lead to a groundbreaking 20% reduction in CVD risk, with potential for nationwide and international translation.
- The Flinders Program's adaptability across diverse settings and clinical disciplines, including peer support, makes it highly relevant for various stakeholders.
Background:
The estimated 300,000 adults in Australia with severe mental illness (SMI) have markedly reduced life expectancy compared to the general population, mainly due to physical health comorbidities. Cardiovascular disease (CVD) is the commonest cause of early death and people with SMI have high rates of most modifiable risk factors, with associated quality of life (QoL) reduction. High blood pressure, smoking, dyslipidaemia, diabetes and obesity are major modifiable CVD risk factors. Poor delivery of recommended monitoring and risk reduction is a national and international problem. Therefore, effective preventive interventions to safeguard and support physical health are urgently needed in this population.
Methods:
This trial used a rigorous process, including extensive piloting, to develop an intervention that delivers recommended physical health care to reduce CVD risk and improve QoL for people with SMI. Components of this intervention are integrated using the Flinders Program of chronic condition management (CCM) which is a comprehensive psychosocial care planning approach that places the patient at the centre of their care, and focuses on building their self-management capacity within a collaborative approach, therefore providing a recovery-oriented framework. The primary project aim is to evaluate the effectiveness and health economics of the CCM intervention. The main outcome measures examine CVD risk and quality of life. The second aim is to identify essential components, enablers and barriers at patient, clinical and organisational levels for national, sustained implementation of recommended physical health care delivery to people with SMI. Participants will be recruited from a community-based public psychiatric service.
Discussion:
This study constitutes the first large-scale trial, worldwide, using the Flinders Program with this population. By combining a standardised yet flexible motivational process with a targeted set of evidence-based interventions, the chief aim is to reduce CVD risk by 20%. If achieved, this will be a ground-breaking outcome, and the program will be subsequently translated nationwide and abroad. The trial will be of great interest to people with mental illness, family carers, mental health services, governments and primary care providers because the Flinders Program can be delivered in diverse settings by any clinical discipline and supervised peers.
Trial Registration:
Australian and New Zealand Clinical Trials Registry, ACTRN12617000474358 . Registered on 31 March 2017.
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