Clinical trial NCT05659498: Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness
Official title: Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness: A Pilot Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Illness Persistent
Cardiovascular Prevention
Keywords: Severe and persistent mental illness
Primary prevention
Measures
Schizophrenia
Schizoaffective disorder
Bipolar disorder
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
First posted: 2022-12-21
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy outcome
timeFrame: 9 months
Secondary outcomes:
measure: 30-year Cardiovascular risk
timeFrame: 9 months
measure: PRIMROSE BMI risk score
timeFrame: 9 months
measure: PRIMROSE Lipid risk score
timeFrame: 9 months
measure: Quality of life
timeFrame: 9 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital/Lady Davis Institute
state: Quebec
Study officials:
affiliation: Lady Davis Institute
name: Michael J Goldfarb
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daumit GL, Dalcin AT, Dickerson FB, Miller ER, Evins AE, Cather C, Jerome GJ, Young DR, Charleston JB, Gennusa JV 3rd, Goldsholl S, Cook C, Heller A, McGinty EE, Crum RM, Appel LJ, Wang NY. Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e207247. doi: 10.1001/jamanetworkopen.2020.7247.
citation: Nielsen RE, Banner J, Jensen SE. Cardiovascular disease in patients with severe mental illness. Nat Rev Cardiol. 2021 Feb;18(2):136-145. doi: 10.1038/s41569-020-00463-7. Epub 2020 Oct 30.
citation: Goldfarb M, De Hert M, Detraux J, Di Palo K, Munir H, Music S, Pina I, Ringen PA. Severe Mental Illness and Cardiovascular Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Aug 30;80(9):918-933. doi: 10.1016/j.jacc.2022.06.017.