Comprehensive Cardiovascular Diseases (CVD) Risk Reduction Trial in Persons With Serious Mental Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 269
- Locations
- 1
- Primary Endpoint
- Global Framingham Risk Score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
IDEAL intervention
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.
Intervention: IDEAL intervention (Other)
Control
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Intervention: Control (Other)
Outcomes
Primary Outcomes
Global Framingham Risk Score
Time Frame: Baseline, 18 months
Global Framingham Cardiovascular disease Risk Score. Higher score indicates higher cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke
Secondary Outcomes
- Weight in Pounds(Baseline, 6 and 18 months)
- Body Mass Index (BMI)(baseline and 18 months)
- Distance Traveled in the 6 Minute Walk Test(Baseline, 6 and 18 months)
- Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption(Baseline, 6 and 18 months)
- Healthy Diet as Indicated by Fast Food Consumption(baseline, 6 and 18 months)
- Fasting Glucose Level(baseline and 18 months)
- Participants With Diabetes Mellitus Treated to Goal (HgBA1c)(Baseline, 6 and 18 months)
- Current Smoking Status(Baseline and 18 months)
- Blood Pressure(baseline and 18 months)
- Participants With Hypertension Treated to Goal(Baseline, 6 and 18 months)
- Total Cholesterol(Baseline and 18 months)
- LDL Cholesterol(Baseline and 18 months)
- HDL Cholesterol(Baseline and 18 months)
- Triglycerides(Baseline and 18 months)
- Participants With Dyslipidemia Treated to Goal(Baseline, 6 and 18 months)