Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness

Study Overview
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Brief Summary
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This study will determine whether a program where a health coach works with participants on heart healthy behaviors and treatment of risk factors is coordinated with primary care can reduce overall heart disease risk in people with serious mental illness.

Detailed Description
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The objective of this study is to perform a randomized clinical trial (IDEAL) to test a comprehensive cardiovascular risk reduction program for persons with serious mental illness. This trial will enroll adult mental health consumers with at least one cardiovascular risk factor and randomize them to the 18-month IDEAL intervention or control. Intervention participants will receive individual cardiovascular risk reduction counseling, coordination with primary care providers to ensure appropriate management of risk factors, and collaboration with mental health staff and social supports to encourage and motivate participants to reach goals. All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. The primary outcome will be the change in estimated cardiovascular risk from the global Framingham Risk Score.

Official Title
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Comprehensive Cardiovascular Diseases (CVD) Risk Reduction Trial in Persons With Serious Mental Illness

Conditions
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Cardiovascular Risk Factors, Serious Mental Illness

Intervention / Treatment
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* Other: IDEAL intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ▪ Age 18 and older ▪ Body mass index at least 25 kg/m2 OR one of the following CVD risk factors: Hypertension (SBP>= 140mmHg or DBP>= 90mmHg or on antihypertensive medications; Diabetes mellitus (fasting blood sugar> 125mg/dl or hemoglobin A1c>6.5 or on a hypoglycemic medication); Dyslipidemia (LDL >130 mg/dl , HDL<40 or total cholesterol >=200 or on a lipid lowering agent); Current tobacco smoker Able and willing to give informed consent Completion of baseline data collection Willing to accept randomization Willing to participate in the intervention Exclusion Criteria: ▪ Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers) Condition which interferes with outcome measurement (e.g., dialysis) Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician. Alcohol or substance use disorder if not sober/abstinent for 30 days Planning to leave rehabilitation center or clinic within 6 months or move out of geographic area within 18 months Investigator judgment (e.g., for concerns about participant or staff safety)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDEAL intervention<br>Individual cardiovascular risk reduction counseling, coordination with primary care providers to ensure appropriate management of risk factors, and collaboration with mental health staff and social supports. All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. | Other: IDEAL intervention<br> <br> |
| Other: Control<br>All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global Framingham Risk Score |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  | 6 and 18 months | 
| BMI |  | 6 and 18 months | 
| 6 minute walk test |  | 6 and 18 months | 
| healthy diet |  | 6 and 18 months | 
| fasting glucose level |  | 6 and 18 months | 
| diabetes mellitus treated to goal (HgBA1c) |  | 6 and 18 months | 
| smoking cessation |  | 6 and 18 months | 
| blood pressure |  | 6 and 18 months | 
| hypertension treated to goal |  | 6 and 18 months | 
| total cholesterol |  | 6 and 18 months | 
| LDL cholesterol |  | 6 and 18 months | 
| HDL cholesterol |  | 6 and 18 months | 
| triglycerides |  | 6 and 18 months | 
| dyslipidemia treated to goal |  | 6 and 18 months |