Mental Illness Persistent, Cardiovascular Prevention
Conditions
Keywords
Severe and persistent mental illness, Primary prevention, Measures, Schizophrenia, Schizoaffective disorder, Bipolar disorder
Brief summary
The goal of this prospective, randomized trial is to explore the link between cardiovascular disease and mortality in individuals with severe and persistent mental illness (SPMI). The main question it aims to answer is: Is a primary prevention cardiac rehabilitation intervention feasible and effective at reducing cardiovascular risk in people with a primary psychotic disorder or bipolar disorder? Participants will undergo a multi-component primary prevention intervention program. Researchers will compare with a control group to see if cardiovascular risk reduction is attained.
Detailed description
This prospective, randomized study aims to recruit 46 adults with schizophrenia, schizoaffective disorder, or bipolar disorder, who are classified as intermediate or high 10-year risk for a cardiovascular event, into a multi-component cardiac rehabilitation intervention program. The aim is to explore the feasibility and efficacy of this multi-component primary prevention intervention program in reducing cardiovascular risk in individuals with SPMI. Evidence supports a high burden of cardiovascular disease and mortality in individuals with SPMI. In link, multiple studies outline disparities in access to quality cardiovascular care in people with SPMI. Given the high CV risk factor burden in people with SPMI and the disparity in access and quality of care, there is a need to screen for CV risk factors and initiate and monitor guideline-directed therapies in people with SPMI. Intervention outcomes will be measured using the Framingham 10-year cardiovascular risk score, the Framingham 30-year cardiovascular risk score, the PRIMOSE BMI and Lipid risk scores, the EQ-5D-5L scale and the CGI score. Continuous variables will be displayed as means, with associated standard deviations. Categorical variables will be represented as frequencies and percentages. Subsequent comparative analysis will take place, where the overall cohort will be characterized into high risk (top quartile) and low risk (bottom quartile) cohorts. This will be accomplished using the chi-squared test or the Fisher exact test, along with the student's t test and the Mann-Whitney U test when appropriate. SPSS 24.0 will be the statistical software used.
Interventions
BEHAVIORALCardiac Rehabilitation Program
The standard cardiac rehabilitation program consists of the following: a (1) consultation with a kinesiologist to assess level of fitness and to prepare an individually customized exercise plan, (2) consultation with a dietitian to guide the participant with healthy nutrition choices, (3) on site supervised and/or virtual exercise sessions with gradual elaboration of a home program, (4) weekly educational capsules and monthly workshops related to cardiac health, and, (5) if deemed necessary by the treating team, consultation with a psychologist, an occupational therapist, a physiotherapist, or a social worker.
Sponsors
Jewish General Hospital
Lady Davis Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking the participant and provider is not possible due to the nature of the intervention
Eligibility
Sex/Gender
ALL
Age
30 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 30 to 59 years old * Psychiatric diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder * 2 or more cardiac risk behaviors or conditions: smoking, obese, hypertension, diabetes, metabolic syndrome, dyslipidemia, obstructive sleep apnea * 10-year Framingham cardiovascular risk score of ≥ 10% (intermediate risk) * Willing to participate in cardiac rehabilitation program
Exclusion criteria
* Psychiatric instability, as judged by treating psychiatrist * Distance from cardiac rehabilitation centre that would preclude participation * Unsafe to participate in the cardiac rehabilitation intervention, as judged by the cardiology assessment * Pregnant * Known coronary artery disease, cerebrovascular disease, or peripheral vascular disease * Court ordered mandatory or tutor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy outcome | 9 months | 10-year Framingham cardiovascular risk score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 9 months | EQ-5D-5L |
| 30-year Cardiovascular risk | 9 months | 30-year Framingham cardiovascular risk score |
| PRIMROSE BMI risk score | 9 months | PRIMROSE BMI risk score |
| PRIMROSE Lipid risk score | 9 months | PRIMROSE Lipid risk score |
Countries
Canada
Contacts
Primary ContactMichael J Goldfarb, MD MSc
Outcome results
None listed