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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL112299 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDEAL intervention | Experimental | 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. |
|
| Control | Other | All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDEAL intervention | Other |
| ||
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Global Framingham Risk Score | 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 | Baseline, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight in Pounds | Weight measured in pounds. | Baseline, 6 and 18 months |
| Body Mass Index (BMI) | Body mass index measured in kg/meter2 |
| Measure | Description | Time Frame |
|---|---|---|
| Health Status With Short Form (SF)-12 | Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Both subscale score ranges are 0-100. Higher scores indicate better physical or mental health. | Baseline, 6 and 18 months |
| Quality of Life Based on the EUROQOL |
Inclusion Criteria:
â–ª Age 18 and older
â–ª 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
Exclusion Criteria:
â–ª Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Gail L. Daumit, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins ProHealth Clinical Research Facility | Woodlawn | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32530472 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. IDEAL intervention |
| FG001 | Control | All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. Control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. IDEAL intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Framingham Risk Score | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 18 months |
|
baseline to 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. IDEAL intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Daumit, MD, MHS | Johns Hopkins University School of Medicine | 410-614-6460 | gdaumit@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2018 | Jun 18, 2025 | Prot_SAP_000.pdf |
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|
| baseline and 18 months |
| Distance Traveled in the 6 Minute Walk Test | 6 minute walk test measured in feet. More feet traveled indicates better results. | Baseline, 6 and 18 months |
| Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed. | Baseline, 6 and 18 months |
| Healthy Diet as Indicated by Fast Food Consumption | Self reported number of times eating at a fast food restaurant per month on average. A higher score indicates a greater frequency of eating fast food. | baseline, 6 and 18 months |
| Fasting Glucose Level | Fasting glucose level reported in mg/dl. | baseline and 18 months |
| Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | A1c Goal used for analysis was <7. | Baseline, 6 and 18 months |
| Current Smoking Status | Self reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point. | Baseline and 18 months |
| Blood Pressure | Systolic and diastolic blood pressure measured in mmhg | baseline and 18 months |
| Participants With Hypertension Treated to Goal | Hypertension goal used for analysis was systolic blood pressure <140 and diastolic blood pressure <90. not modeled | Baseline, 6 and 18 months |
| Total Cholesterol | Total cholesterol measured in mg/dl | Baseline and 18 months |
| LDL Cholesterol | LDL cholesterol measured in mg/dl | Baseline and 18 months |
| HDL Cholesterol | HDL cholesterol measured in mg/dl | Baseline and 18 months |
| Triglycerides | Triglycerides measured in mg/dl | Baseline and 18 months |
| Participants With Dyslipidemia Treated to Goal | Goal used for analysis was LDL cholesterol < 130 mg/dl and Total cholesterol < 200mg/dl. | Baseline, 6 and 18 months |
Self reported measured by the EUROQOL EQ-5D-3L. A higher score indicates better health and a lower score indicates worse health; on a scale of 0 to 1. Not modeled. |
| Baseline, 6 and 18 months |
| Medication Adherence | Used medication adherence measure designed by Morisky et al and separately evaluated somatic and psychiatric medications. | Baseline, 6 and 18 months |
| Medication Use for Cardiovascular Risk Factors | Medications as reported by participant and then categorized by research study nurse into hypertension, diabetes, dyslipidemia and smoking cessation. Will report the number of participants taking at least one medication in each category of those with the specified condition at baseline. | Baseline, 6 and 18 months |
| Physician Decision |
|
| incarceration |
|
| Did not have full Framingham risk score measured |
|
| BG001 | Control | All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. Control |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| primary psychiatric diagnosis | Count of Participants | Participants |
|
| Number of cardiovascular disease (CVD) risk factors | Count of Participants | Participants |
|
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|
|
| Secondary | Weight in Pounds | Weight measured in pounds. | Posted | Mean | Standard Deviation | pounds | Baseline, 6 and 18 months |
|
|
|
| Secondary | Body Mass Index (BMI) | Body mass index measured in kg/meter2 | Posted | Mean | Standard Deviation | kg/m^2 | baseline and 18 months |
|
|
|
|
| Secondary | Distance Traveled in the 6 Minute Walk Test | 6 minute walk test measured in feet. More feet traveled indicates better results. | Data reported on all clients who completed measure at timepoint. Data was not modeled. | Posted | Mean | Standard Deviation | feet | Baseline, 6 and 18 months |
|
|
|
| Secondary | Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed. | Data reported on all clients with data collected at timepoints Data was not modeled. | Posted | Mean | Standard Deviation | Sugar sweetened beverages per week | Baseline, 6 and 18 months |
|
|
|
| Secondary | Healthy Diet as Indicated by Fast Food Consumption | Self reported number of times eating at a fast food restaurant per month on average. A higher score indicates a greater frequency of eating fast food. | Data reported on all clients with data collected at timepoints. Data was not modeled. | Posted | Mean | Standard Deviation | Fast food per month | baseline, 6 and 18 months |
|
|
|
| Secondary | Fasting Glucose Level | Fasting glucose level reported in mg/dl. | Posted | Mean | Standard Deviation | mg/dl | baseline and 18 months |
|
|
|
|
| Secondary | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | A1c Goal used for analysis was <7. | Only those with diabetes at baseline were included in analysis and data is reported on all clients with data collected at timepoints. Data was not modeled. | Posted | Count of Participants | Participants | Baseline, 6 and 18 months |
|
|
|
|
| Secondary | Current Smoking Status | Self reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point. | Posted | Count of Participants | Participants | Baseline and 18 months |
|
|
|
|
| Secondary | Blood Pressure | Systolic and diastolic blood pressure measured in mmhg | Posted | Mean | Standard Deviation | mmhg | baseline and 18 months |
|
|
|
|
| Secondary | Participants With Hypertension Treated to Goal | Hypertension goal used for analysis was systolic blood pressure <140 and diastolic blood pressure <90. not modeled | Only those with hypertension at baseline were included in analysis and data is reported on all clients with data collected at timepoints. Data was not modeled. | Posted | Count of Participants | Participants | Baseline, 6 and 18 months |
|
|
|
| Secondary | Total Cholesterol | Total cholesterol measured in mg/dl | Posted | Mean | Standard Deviation | mg/dl | Baseline and 18 months |
|
|
|
|
| Secondary | LDL Cholesterol | LDL cholesterol measured in mg/dl | Posted | Mean | Standard Deviation | mg/dl | Baseline and 18 months |
|
|
|
|
| Secondary | HDL Cholesterol | HDL cholesterol measured in mg/dl | Posted | Mean | Standard Deviation | mg/dl | Baseline and 18 months |
|
|
|
|
| Secondary | Triglycerides | Triglycerides measured in mg/dl | Posted | Mean | Standard Deviation | mg/dl | Baseline and 18 months |
|
|
|
|
| Secondary | Participants With Dyslipidemia Treated to Goal | Goal used for analysis was LDL cholesterol < 130 mg/dl and Total cholesterol < 200mg/dl. | Only those with dyslipidemia at baseline were included in analysis and data is reported on all clients with data collected at timepoints. Data was not modeled. | Posted | Count of Participants | Participants | Baseline, 6 and 18 months |
|
|
|
| Other Pre-specified | Health Status With Short Form (SF)-12 | Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Both subscale score ranges are 0-100. Higher scores indicate better physical or mental health. | Participants with data collected at the timepoints | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 and 18 months |
|
|
|
| Other Pre-specified | Quality of Life Based on the EUROQOL | Self reported measured by the EUROQOL EQ-5D-3L. A higher score indicates better health and a lower score indicates worse health; on a scale of 0 to 1. Not modeled. | Data reported on all clients with data collected at timepoints. Data was not modeled. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 and 18 months |
|
|
|
| Other Pre-specified | Medication Adherence | Used medication adherence measure designed by Morisky et al and separately evaluated somatic and psychiatric medications. | Data reported on all clients with data collected at timepoints. Data was not modeled. | Posted | Count of Participants | Participants | Baseline, 6 and 18 months |
|
|
|
| Other Pre-specified | Medication Use for Cardiovascular Risk Factors | Medications as reported by participant and then categorized by research study nurse into hypertension, diabetes, dyslipidemia and smoking cessation. Will report the number of participants taking at least one medication in each category of those with the specified condition at baseline. | Only includes those with specified condition at baseline were included in analysis and data is reported on all clients with data collected at timepoints. Data was not modeled. | Posted | Count of Participants | Participants | Baseline, 6 and 18 months |
|
|
|
| 2 |
| 132 |
| 29 |
| 132 |
| 0 |
| 132 |
| EG001 | Control | All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. Control | 2 | 137 | 35 | 137 | 0 | 137 |
| medical hospitalization | General disorders | Systematic Assessment |
|
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| 18 month |
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| 6 months |
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| 18 months |
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| 6 month |
|
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| 18 month |
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| 6 month |
|
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| 18 month |
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| No |
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| 6 month |
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| 18 month |
|
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| 18 month systolic blood pressure |
|
| 18 month diastolic blood pressure |
|
| Mean Difference (Net) |
| -1.7 |
| 2-Sided |
| 95 |
| -3.8 |
| 0.5 |
| Superiority |
| No |
|
| 6 month |
|
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| 18 months |
|
|
| No |
|
| 6 month |
|
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| 18 month |
|
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| Physical - 6 months |
|
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| Physical - 18 months |
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| Mental - Baseline |
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| Mental - 6 months |
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| Mental - 18 months |
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| 6 months |
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| 18 months |
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| Moderate adherence |
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| Poor adherence |
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| Reported not taking medication type |
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| Somatic - 6 months |
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| Somatic - 18 months |
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| Psychiatric - Baseline |
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| Psychiatric - 6 months |
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| Psychiatric - 18 months |
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| Did not report medication for risk factor |
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| Hypertension - 6 months |
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| Hypertension - 18 months |
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| Diabetes - Baseline |
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| Diabetes - 6 months |
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| Diabetes - 18 months |
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| Dyslipidemia - Baseline |
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| Dyslipidemia - 6 months |
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| Dyslipidemia - 18 months |
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| Smoking cessation - Baseline |
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| Smoking cessation - 6 months |
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| Smoking cessation - 18 months |
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