Cardiovascular Risk Factors, Serious Mental Illness
Conditions
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.
Interventions
OTHERIDEAL intervention
OTHERControl
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Framingham Risk Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | Baseline, 6 and 18 months | A1c Goal used for analysis was \<7. |
| LDL Cholesterol | Baseline and 18 months | LDL cholesterol measured in mg/dl |
| HDL Cholesterol | Baseline and 18 months | HDL cholesterol measured in mg/dl |
| Triglycerides | Baseline and 18 months | Triglycerides measured in mg/dl |
| Participants With Dyslipidemia Treated to Goal | Baseline, 6 and 18 months | Goal used for analysis was LDL cholesterol \< 130 mg/dl and Total cholesterol \< 200mg/dl. |
| Weight in Pounds | Baseline, 6 and 18 months | Weight measured in pounds. |
| Body Mass Index (BMI) | baseline and 18 months | Body mass index measured in kg/meter2 |
| Distance Traveled in the 6 Minute Walk Test | Baseline, 6 and 18 months | 6 minute walk test measured in feet. More feet traveled indicates better results. |
| Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | Baseline, 6 and 18 months | Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed. |
| Healthy Diet as Indicated by Fast Food Consumption | baseline, 6 and 18 months | 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. |
| Fasting Glucose Level | baseline and 18 months | Fasting glucose level reported in mg/dl. |
| Current Smoking Status | Baseline and 18 months | Self reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point. |
| Blood Pressure | baseline and 18 months | Systolic and diastolic blood pressure measured in mmhg |
| Participants With Hypertension Treated to Goal | Baseline, 6 and 18 months | Hypertension goal used for analysis was systolic blood pressure \<140 and diastolic blood pressure \<90. not modeled |
| Total Cholesterol | Baseline and 18 months | Total cholesterol measured in mg/dl |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | Baseline, 6 and 18 months | Used medication adherence measure designed by Morisky et al and separately evaluated somatic and psychiatric medications. |
| Medication Use for Cardiovascular Risk Factors | Baseline, 6 and 18 months | 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. |
| Health Status With Short Form (SF)-12 | Baseline, 6 and 18 months | 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. |
| Quality of Life Based on the EUROQOL | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 132 |
| Control All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control | 137 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Did not have full Framingham risk score measured | 1 | 0 |
| Overall Study | incarceration | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Total | IDEAL Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 17 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 124 Participants | 252 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 133 Participants | 263 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of cardiovascular disease (CVD) risk factors 1 cvd risk factors | 20 Participants | 34 Participants | 14 Participants |
| Number of cardiovascular disease (CVD) risk factors 2 cvd risk factors | 23 Participants | 60 Participants | 37 Participants |
| Number of cardiovascular disease (CVD) risk factors 3 cvd risk factors | 47 Participants | 86 Participants | 39 Participants |
| Number of cardiovascular disease (CVD) risk factors 4 cvd risk factors | 34 Participants | 67 Participants | 33 Participants |
| Number of cardiovascular disease (CVD) risk factors 5 cvd risk factors | 13 Participants | 22 Participants | 9 Participants |
| primary psychiatric diagnosis bipolar disorder | 42 Participants | 67 Participants | 25 Participants |
| primary psychiatric diagnosis major depressive disorder | 18 Participants | 38 Participants | 20 Participants |
| primary psychiatric diagnosis other psychotic disorder | 4 Participants | 5 Participants | 1 Participants |
| primary psychiatric diagnosis schizoaffective disorder | 32 Participants | 78 Participants | 46 Participants |
| primary psychiatric diagnosis schizophrenia | 41 Participants | 81 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 124 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 68 Participants | 135 Participants | 67 Participants |
| Region of Enrollment United States | 137 Participants | 269 Participants | 132 Participants |
| Sex: Female, Male Female | 71 Participants | 141 Participants | 70 Participants |
| Sex: Female, Male Male | 66 Participants | 128 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 132 | 2 / 137 |
| other Total, other adverse events | 0 / 132 | 0 / 137 |
| serious Total, serious adverse events | 29 / 132 | 35 / 137 |
Outcome results
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
Time frame: Baseline, 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Global Framingham Risk Score | Baseline | 11.5 score on a scale | Standard Deviation 11.5 |
| IDEAL Intervention | Global Framingham Risk Score | 18 months | 9.9 score on a scale | Standard Deviation 10.2 |
| Control | Global Framingham Risk Score | Baseline | 12.7 score on a scale | Standard Deviation 12.7 |
| Control | Global Framingham Risk Score | 18 months | 12.3 score on a scale | Standard Deviation 12 |
95% CI: [-22.9, -2.5]
Secondary
Blood Pressure
Systolic and diastolic blood pressure measured in mmhg
Time frame: baseline and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Blood Pressure | Baseline systolic blood pressure | 118.0 mmhg | Standard Deviation 13 |
| IDEAL Intervention | Blood Pressure | Baseline diastolic blood pressure | 75.3 mmhg | Standard Deviation 8.2 |
| IDEAL Intervention | Blood Pressure | 18 month systolic blood pressure | 120.1 mmhg | Standard Deviation 14.5 |
| IDEAL Intervention | Blood Pressure | 18 month diastolic blood pressure | 73.9 mmhg | Standard Deviation 9.2 |
| Control | Blood Pressure | 18 month diastolic blood pressure | 74.7 mmhg | Standard Deviation 11.1 |
| Control | Blood Pressure | Baseline systolic blood pressure | 116.5 mmhg | Standard Deviation 12.9 |
| Control | Blood Pressure | 18 month systolic blood pressure | 120.2 mmhg | Standard Deviation 16.2 |
| Control | Blood Pressure | Baseline diastolic blood pressure | 74.9 mmhg | Standard Deviation 9.3 |
Comparison: systolic95% CI: [-5.1, 1.5]
Comparison: diastolic95% CI: [-3.8, 0.5]
Secondary
Body Mass Index (BMI)
Body mass index measured in kg/meter2
Time frame: baseline and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Body Mass Index (BMI) | Baseline | 34.4 kg/m^2 | Standard Deviation 7.8 |
| IDEAL Intervention | Body Mass Index (BMI) | 18 months | 33.7 kg/m^2 | Standard Deviation 7.7 |
| Control | Body Mass Index (BMI) | Baseline | 32.9 kg/m^2 | Standard Deviation 6.6 |
| Control | Body Mass Index (BMI) | 18 months | 32.1 kg/m^2 | Standard Deviation 6.6 |
95% CI: [-0.7, 0.9]
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.
Time frame: Baseline and 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IDEAL Intervention | Current Smoking Status | Baseline | 65 Participants |
| IDEAL Intervention | Current Smoking Status | 18 months | 47 Participants |
| Control | Current Smoking Status | Baseline | 73 Participants |
| Control | Current Smoking Status | 18 months | 67 Participants |
95% CI: [-18.4, -2.6]
Secondary
Distance Traveled in the 6 Minute Walk Test
6 minute walk test measured in feet. More feet traveled indicates better results.
Time frame: Baseline, 6 and 18 months
Population: Data reported on all clients who completed measure at timepoint. Data was not modeled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Distance Traveled in the 6 Minute Walk Test | Baseline | 909.5 feet | Standard Deviation 233.4 |
| IDEAL Intervention | Distance Traveled in the 6 Minute Walk Test | 6 months | 922.9 feet | Standard Deviation 248.2 |
| IDEAL Intervention | Distance Traveled in the 6 Minute Walk Test | 18 months | 925.1 feet | Standard Deviation 217.3 |
| Control | Distance Traveled in the 6 Minute Walk Test | Baseline | 910.7 feet | Standard Deviation 249.6 |
| Control | Distance Traveled in the 6 Minute Walk Test | 6 months | 926.9 feet | Standard Deviation 239.4 |
| Control | Distance Traveled in the 6 Minute Walk Test | 18 months | 910.7 feet | Standard Deviation 249.6 |
Secondary
Fasting Glucose Level
Fasting glucose level reported in mg/dl.
Time frame: baseline and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Fasting Glucose Level | baseline | 106.5 mg/dl | Standard Deviation 36.7 |
| IDEAL Intervention | Fasting Glucose Level | 18 months | 106.7 mg/dl | Standard Deviation 45.2 |
| Control | Fasting Glucose Level | baseline | 110.6 mg/dl | Standard Deviation 36.9 |
| Control | Fasting Glucose Level | 18 months | 117.4 mg/dl | Standard Deviation 60 |
95% CI: [-17.6, 2.4]
Secondary
HDL Cholesterol
HDL cholesterol measured in mg/dl
Time frame: Baseline and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | HDL Cholesterol | baseline | 49.2 mg/dl | Standard Deviation 15.3 |
| IDEAL Intervention | HDL Cholesterol | 18 months | 50.7 mg/dl | Standard Deviation 14.8 |
| Control | HDL Cholesterol | baseline | 50.2 mg/dl | Standard Deviation 19.3 |
| Control | HDL Cholesterol | 18 months | 51.0 mg/dl | Standard Deviation 17.7 |
95% CI: [-1.8, 3.8]
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.
Time frame: baseline, 6 and 18 months
Population: Data reported on all clients with data collected at timepoints. Data was not modeled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Healthy Diet as Indicated by Fast Food Consumption | 18 month | 3.8 Fast food per month | Standard Deviation 8.5 |
| IDEAL Intervention | Healthy Diet as Indicated by Fast Food Consumption | Baseline | 4.3 Fast food per month | Standard Deviation 6.5 |
| IDEAL Intervention | Healthy Diet as Indicated by Fast Food Consumption | 6 month | 3.7 Fast food per month | Standard Deviation 5.8 |
| Control | Healthy Diet as Indicated by Fast Food Consumption | 6 month | 5.2 Fast food per month | Standard Deviation 10.4 |
| Control | Healthy Diet as Indicated by Fast Food Consumption | 18 month | 3.8 Fast food per month | Standard Deviation 9.3 |
| Control | Healthy Diet as Indicated by Fast Food Consumption | Baseline | 3.9 Fast food per month | Standard Deviation 7 |
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.
Time frame: Baseline, 6 and 18 months
Population: Data reported on all clients with data collected at timepoints Data was not modeled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | Baseline | 8.8 Sugar sweetened beverages per week | Standard Deviation 9.7 |
| IDEAL Intervention | Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | 6 month | 8.4 Sugar sweetened beverages per week | Standard Deviation 9.8 |
| IDEAL Intervention | Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | 18 month | 9.1 Sugar sweetened beverages per week | Standard Deviation 11.7 |
| Control | Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | Baseline | 9.8 Sugar sweetened beverages per week | Standard Deviation 9.8 |
| Control | Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | 6 month | 11.1 Sugar sweetened beverages per week | Standard Deviation 12.9 |
| Control | Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption | 18 month | 11.3 Sugar sweetened beverages per week | Standard Deviation 12.6 |
Secondary
LDL Cholesterol
LDL cholesterol measured in mg/dl
Time frame: Baseline and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | LDL Cholesterol | baseline | 101.9 mg/dl | Standard Deviation 36.8 |
| IDEAL Intervention | LDL Cholesterol | 18 months | 93.7 mg/dl | Standard Deviation 33.5 |
| Control | LDL Cholesterol | baseline | 101.0 mg/dl | Standard Deviation 33.4 |
| Control | LDL Cholesterol | 18 months | 97.3 mg/dl | Standard Deviation 35.9 |
95% CI: [-12.7, 2]
Secondary
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
A1c Goal used for analysis was \<7.
Time frame: Baseline, 6 and 18 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IDEAL Intervention | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | baseline | Yes | 27 Participants |
| IDEAL Intervention | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | baseline | No | 15 Participants |
| IDEAL Intervention | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 6 month | Yes | 29 Participants |
| IDEAL Intervention | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 6 month | No | 12 Participants |
| IDEAL Intervention | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 18 month | Yes | 31 Participants |
| IDEAL Intervention | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 18 month | No | 7 Participants |
| Control | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 18 month | Yes | 26 Participants |
| Control | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | baseline | Yes | 25 Participants |
| Control | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 6 month | No | 24 Participants |
| Control | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | baseline | No | 26 Participants |
| Control | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 18 month | No | 22 Participants |
| Control | Participants With Diabetes Mellitus Treated to Goal (HgBA1c) | 6 month | Yes | 23 Participants |
95% CI: [-0.3, 0.2]
Secondary
Participants With Dyslipidemia Treated to Goal
Goal used for analysis was LDL cholesterol \< 130 mg/dl and Total cholesterol \< 200mg/dl.
Time frame: Baseline, 6 and 18 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IDEAL Intervention | Participants With Dyslipidemia Treated to Goal | Baseline | Yes | 46 Participants |
| IDEAL Intervention | Participants With Dyslipidemia Treated to Goal | Baseline | No | 36 Participants |
| IDEAL Intervention | Participants With Dyslipidemia Treated to Goal | 6 month | Yes | 47 Participants |
| IDEAL Intervention | Participants With Dyslipidemia Treated to Goal | 6 month | No | 29 Participants |
| IDEAL Intervention | Participants With Dyslipidemia Treated to Goal | 18 month | Yes | 57 Participants |
| IDEAL Intervention | Participants With Dyslipidemia Treated to Goal | 18 month | No | 18 Participants |
| Control | Participants With Dyslipidemia Treated to Goal | 18 month | Yes | 63 Participants |
| Control | Participants With Dyslipidemia Treated to Goal | Baseline | Yes | 53 Participants |
| Control | Participants With Dyslipidemia Treated to Goal | 6 month | No | 29 Participants |
| Control | Participants With Dyslipidemia Treated to Goal | Baseline | No | 40 Participants |
| Control | Participants With Dyslipidemia Treated to Goal | 18 month | No | 24 Participants |
| Control | Participants With Dyslipidemia Treated to Goal | 6 month | Yes | 55 Participants |
Secondary
Participants With Hypertension Treated to Goal
Hypertension goal used for analysis was systolic blood pressure \<140 and diastolic blood pressure \<90. not modeled
Time frame: Baseline, 6 and 18 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IDEAL Intervention | Participants With Hypertension Treated to Goal | baseline | Yes | 61 Participants |
| IDEAL Intervention | Participants With Hypertension Treated to Goal | baseline | No | 11 Participants |
| IDEAL Intervention | Participants With Hypertension Treated to Goal | 6 month | Yes | 62 Participants |
| IDEAL Intervention | Participants With Hypertension Treated to Goal | 6 month | No | 8 Participants |
| IDEAL Intervention | Participants With Hypertension Treated to Goal | 18 months | Yes | 57 Participants |
| IDEAL Intervention | Participants With Hypertension Treated to Goal | 18 months | No | 8 Participants |
| Control | Participants With Hypertension Treated to Goal | 18 months | Yes | 51 Participants |
| Control | Participants With Hypertension Treated to Goal | baseline | Yes | 54 Participants |
| Control | Participants With Hypertension Treated to Goal | 6 month | No | 13 Participants |
| Control | Participants With Hypertension Treated to Goal | baseline | No | 16 Participants |
| Control | Participants With Hypertension Treated to Goal | 18 months | No | 17 Participants |
| Control | Participants With Hypertension Treated to Goal | 6 month | Yes | 55 Participants |
Secondary
Total Cholesterol
Total cholesterol measured in mg/dl
Time frame: Baseline and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Total Cholesterol | baseline | 178.9 mg/dl | Standard Deviation 42.1 |
| IDEAL Intervention | Total Cholesterol | 18 month | 171.8 mg/dl | Standard Deviation 38.3 |
| Control | Total Cholesterol | baseline | 181.1 mg/dl | Standard Deviation 41.6 |
| Control | Total Cholesterol | 18 month | 177.7 mg/dl | Standard Deviation 48.7 |
95% CI: [-13.3, 4.7]
Secondary
Triglycerides
Triglycerides measured in mg/dl
Time frame: Baseline and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Triglycerides | baseline | 140.2 mg/dl | Standard Deviation 74.3 |
| IDEAL Intervention | Triglycerides | 18 months | 141.0 mg/dl | Standard Deviation 76.9 |
| Control | Triglycerides | baseline | 156.6 mg/dl | Standard Deviation 106.7 |
| Control | Triglycerides | 18 months | 149.0 mg/dl | Standard Deviation 111.1 |
95% CI: [-13.4, 29.6]
Secondary
Weight in Pounds
Weight measured in pounds.
Time frame: Baseline, 6 and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Weight in Pounds | Baseline | 219.5 pounds | Standard Deviation 53.3 |
| IDEAL Intervention | Weight in Pounds | 6 month | 216.9 pounds | Standard Deviation 49.1 |
| IDEAL Intervention | Weight in Pounds | 18 month | 213.2 pounds | Standard Deviation 51.6 |
| Control | Weight in Pounds | Baseline | 208.6 pounds | Standard Deviation 48 |
| Control | Weight in Pounds | 6 month | 208.3 pounds | Standard Deviation 49.9 |
| Control | Weight in Pounds | 18 month | 202.9 pounds | Standard Deviation 46.9 |
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.
Time frame: Baseline, 6 and 18 months
Population: Participants with data collected at the timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Health Status With Short Form (SF)-12 | Physical - Baseline | 45.3 score on a scale | Standard Deviation 9.1 |
| IDEAL Intervention | Health Status With Short Form (SF)-12 | Physical - 6 months | 45.2 score on a scale | Standard Deviation 9.3 |
| IDEAL Intervention | Health Status With Short Form (SF)-12 | Physical - 18 months | 46.8 score on a scale | Standard Deviation 8.4 |
| IDEAL Intervention | Health Status With Short Form (SF)-12 | Mental - Baseline | 47.3 score on a scale | Standard Deviation 8.3 |
| IDEAL Intervention | Health Status With Short Form (SF)-12 | Mental - 6 months | 48.7 score on a scale | Standard Deviation 8.1 |
| IDEAL Intervention | Health Status With Short Form (SF)-12 | Mental - 18 months | 49.3 score on a scale | Standard Deviation 7.7 |
| Control | Health Status With Short Form (SF)-12 | Mental - 6 months | 48.2 score on a scale | Standard Deviation 7.2 |
| Control | Health Status With Short Form (SF)-12 | Physical - Baseline | 43.9 score on a scale | Standard Deviation 10 |
| Control | Health Status With Short Form (SF)-12 | Mental - Baseline | 47.9 score on a scale | Standard Deviation 8.5 |
| Control | Health Status With Short Form (SF)-12 | Physical - 6 months | 44.0 score on a scale | Standard Deviation 9.1 |
| Control | Health Status With Short Form (SF)-12 | Mental - 18 months | 48.7 score on a scale | Standard Deviation 8.3 |
| Control | Health Status With Short Form (SF)-12 | Physical - 18 months | 44.6 score on a scale | Standard Deviation 8.9 |
Other Pre-specified
Medication Adherence
Used medication adherence measure designed by Morisky et al and separately evaluated somatic and psychiatric medications.
Time frame: Baseline, 6 and 18 months
Population: Data reported on all clients with data collected at timepoints. Data was not modeled.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IDEAL Intervention | Medication Adherence | Somatic - 6 months | Poor adherence | 28 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - Baseline | Moderate adherence | 39 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - Baseline | Poor adherence | 21 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - Baseline | Reported not taking medication type | 27 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - 6 months | Good adherence | 39 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - 6 months | Moderate adherence | 43 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - Baseline | Good adherence | 45 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - 6 months | Reported not taking medication type | 12 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - 18 months | Good adherence | 49 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - 18 months | Moderate adherence | 31 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - 18 months | Poor adherence | 23 Participants |
| IDEAL Intervention | Medication Adherence | Somatic - 18 months | Reported not taking medication type | 12 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - Baseline | Good adherence | 40 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - Baseline | Moderate adherence | 54 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - Baseline | Poor adherence | 37 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - Baseline | Reported not taking medication type | 1 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 6 months | Good adherence | 33 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 6 months | Moderate adherence | 50 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 6 months | Poor adherence | 38 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 6 months | Reported not taking medication type | 1 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 18 months | Good adherence | 41 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 18 months | Moderate adherence | 49 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 18 months | Poor adherence | 25 Participants |
| IDEAL Intervention | Medication Adherence | Psychiatric - 18 months | Reported not taking medication type | 0 Participants |
| Control | Medication Adherence | Psychiatric - 18 months | Poor adherence | 38 Participants |
| Control | Medication Adherence | Somatic - Baseline | Good adherence | 51 Participants |
| Control | Medication Adherence | Psychiatric - Baseline | Good adherence | 49 Participants |
| Control | Medication Adherence | Somatic - Baseline | Moderate adherence | 41 Participants |
| Control | Medication Adherence | Psychiatric - 6 months | Poor adherence | 39 Participants |
| Control | Medication Adherence | Somatic - Baseline | Poor adherence | 26 Participants |
| Control | Medication Adherence | Psychiatric - Baseline | Moderate adherence | 50 Participants |
| Control | Medication Adherence | Somatic - Baseline | Reported not taking medication type | 19 Participants |
| Control | Medication Adherence | Psychiatric - 18 months | Moderate adherence | 40 Participants |
| Control | Medication Adherence | Somatic - 6 months | Good adherence | 45 Participants |
| Control | Medication Adherence | Psychiatric - Baseline | Poor adherence | 37 Participants |
| Control | Medication Adherence | Somatic - 6 months | Moderate adherence | 41 Participants |
| Control | Medication Adherence | Psychiatric - 6 months | Reported not taking medication type | 1 Participants |
| Control | Medication Adherence | Somatic - 6 months | Poor adherence | 25 Participants |
| Control | Medication Adherence | Psychiatric - Baseline | Reported not taking medication type | 1 Participants |
| Control | Medication Adherence | Somatic - 6 months | Reported not taking medication type | 14 Participants |
| Control | Medication Adherence | Psychiatric - 18 months | Reported not taking medication type | 2 Participants |
| Control | Medication Adherence | Somatic - 18 months | Good adherence | 46 Participants |
| Control | Medication Adherence | Psychiatric - 6 months | Good adherence | 43 Participants |
| Control | Medication Adherence | Somatic - 18 months | Moderate adherence | 43 Participants |
| Control | Medication Adherence | Psychiatric - 18 months | Good adherence | 41 Participants |
| Control | Medication Adherence | Somatic - 18 months | Poor adherence | 22 Participants |
| Control | Medication Adherence | Psychiatric - 6 months | Moderate adherence | 42 Participants |
| Control | Medication Adherence | Somatic - 18 months | Reported not taking medication type | 10 Participants |
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.
Time frame: Baseline, 6 and 18 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Diabetes - Baseline | Reported medication for risk factor | 33 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Hypertension - Baseline | Reported medication for risk factor | 6 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Hypertension - Baseline | Did not report medication for risk factor | 66 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Hypertension - 6 months | Reported medication for risk factor | 59 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Hypertension - 6 months | Did not report medication for risk factor | 9 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Hypertension - 18 months | Reported medication for risk factor | 51 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Hypertension - 18 months | Did not report medication for risk factor | 7 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Diabetes - Baseline | Did not report medication for risk factor | 9 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Diabetes - 6 months | Reported medication for risk factor | 35 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Diabetes - 6 months | Did not report medication for risk factor | 4 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Diabetes - 18 months | Reported medication for risk factor | 29 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Diabetes - 18 months | Did not report medication for risk factor | 5 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - Baseline | Reported medication for risk factor | 59 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - Baseline | Did not report medication for risk factor | 23 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 6 months | Reported medication for risk factor | 54 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 6 months | Did not report medication for risk factor | 23 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 18 months | Reported medication for risk factor | 49 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 18 months | Did not report medication for risk factor | 20 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Smoking cessation - Baseline | Reported medication for risk factor | 6 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Smoking cessation - Baseline | Did not report medication for risk factor | 59 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 6 months | Reported medication for risk factor | 12 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 6 months | Did not report medication for risk factor | 48 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 18 months | Reported medication for risk factor | 14 Participants |
| IDEAL Intervention | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 18 months | Did not report medication for risk factor | 41 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 18 months | Reported medication for risk factor | 3 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - Baseline | Reported medication for risk factor | 75 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Hypertension - Baseline | Reported medication for risk factor | 5 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Smoking cessation - Baseline | Reported medication for risk factor | 1 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - Baseline | Did not report medication for risk factor | 17 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Hypertension - 6 months | Reported medication for risk factor | 55 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 6 months | Did not report medication for risk factor | 64 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Hypertension - 6 months | Did not report medication for risk factor | 12 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 6 months | Reported medication for risk factor | 68 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Hypertension - 18 months | Reported medication for risk factor | 47 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Smoking cessation - Baseline | Did not report medication for risk factor | 71 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Hypertension - 18 months | Did not report medication for risk factor | 11 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Hypertension - Baseline | Did not report medication for risk factor | 65 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Diabetes - Baseline | Reported medication for risk factor | 41 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 6 months | Did not report medication for risk factor | 17 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Diabetes - Baseline | Did not report medication for risk factor | 10 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 18 months | Did not report medication for risk factor | 57 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Diabetes - 6 months | Reported medication for risk factor | 41 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 18 months | Reported medication for risk factor | 61 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Diabetes - 6 months | Did not report medication for risk factor | 6 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Smoking cessation - 6 months | Reported medication for risk factor | 3 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Diabetes - 18 months | Reported medication for risk factor | 37 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Dyslipidemia - 18 months | Did not report medication for risk factor | 18 Participants |
| Control | Medication Use for Cardiovascular Risk Factors | Diabetes - 18 months | Did not report medication for risk factor | 4 Participants |
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.
Time frame: Baseline, 6 and 18 months
Population: Data reported on all clients with data collected at timepoints. Data was not modeled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDEAL Intervention | Quality of Life Based on the EUROQOL | Baseline | 0.75 score on a scale | Standard Deviation 0.2 |
| IDEAL Intervention | Quality of Life Based on the EUROQOL | 6 months | 0.77 score on a scale | Standard Deviation 0.2 |
| IDEAL Intervention | Quality of Life Based on the EUROQOL | 18 months | 0.82 score on a scale | Standard Deviation 0.19 |
| Control | Quality of Life Based on the EUROQOL | Baseline | 0.74 score on a scale | Standard Deviation 0.2 |
| Control | Quality of Life Based on the EUROQOL | 6 months | 0.76 score on a scale | Standard Deviation 0.19 |
| Control | Quality of Life Based on the EUROQOL | 18 months | 0.79 score on a scale | Standard Deviation 0.2 |