Trial Outcomes & Findings for Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness (NCT NCT02127671)
NCT ID: NCT02127671
Last Updated: 2025-08-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
269 participants
Primary outcome timeframe
Baseline, 18 months
Results posted on
2025-08-11
Participant Flow
Participant milestones
| Measure |
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
|
Control
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
137
|
|
Overall Study
COMPLETED
|
124
|
132
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
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
|
Control
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
incarceration
|
0
|
1
|
|
Overall Study
Did not have full Framingham risk score measured
|
1
|
0
|
Baseline Characteristics
Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness
Baseline characteristics by cohort
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
128 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
132 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
schizophrenia
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
schizoaffective disorder
|
46 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
bipolar disorder
|
25 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
major depressive disorder
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
other psychotic disorder
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of cardiovascular disease (CVD) risk factors
1 cvd risk factors
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Number of cardiovascular disease (CVD) risk factors
2 cvd risk factors
|
37 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Number of cardiovascular disease (CVD) risk factors
3 cvd risk factors
|
39 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Number of cardiovascular disease (CVD) risk factors
4 cvd risk factors
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Number of cardiovascular disease (CVD) risk factors
5 cvd risk factors
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 18 monthsGlobal 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
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Global Framingham Risk Score
Baseline
|
11.5 score on a scale
Standard Deviation 11.5
|
12.7 score on a scale
Standard Deviation 12.7
|
|
Global Framingham Risk Score
18 months
|
9.9 score on a scale
Standard Deviation 10.2
|
12.3 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsWeight measured in pounds.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Weight in Pounds
Baseline
|
219.5 pounds
Standard Deviation 53.3
|
208.6 pounds
Standard Deviation 48.0
|
|
Weight in Pounds
6 month
|
216.9 pounds
Standard Deviation 49.1
|
208.3 pounds
Standard Deviation 49.9
|
|
Weight in Pounds
18 month
|
213.2 pounds
Standard Deviation 51.6
|
202.9 pounds
Standard Deviation 46.9
|
SECONDARY outcome
Timeframe: baseline and 18 monthsBody mass index measured in kg/meter2
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Body Mass Index (BMI)
Baseline
|
34.4 kg/m^2
Standard Deviation 7.8
|
32.9 kg/m^2
Standard Deviation 6.6
|
|
Body Mass Index (BMI)
18 months
|
33.7 kg/m^2
Standard Deviation 7.7
|
32.1 kg/m^2
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: Data reported on all clients who completed measure at timepoint. Data was not modeled.
6 minute walk test measured in feet. More feet traveled indicates better results.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=134 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Distance Traveled in the 6 Minute Walk Test
Baseline
|
909.5 feet
Standard Deviation 233.4
|
910.7 feet
Standard Deviation 249.6
|
|
Distance Traveled in the 6 Minute Walk Test
6 months
|
922.9 feet
Standard Deviation 248.2
|
926.9 feet
Standard Deviation 239.4
|
|
Distance Traveled in the 6 Minute Walk Test
18 months
|
925.1 feet
Standard Deviation 217.3
|
910.7 feet
Standard Deviation 249.6
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: Data reported on all clients with data collected at timepoints Data was not modeled.
Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption
Baseline
|
8.8 Sugar sweetened beverages per week
Standard Deviation 9.7
|
9.8 Sugar sweetened beverages per week
Standard Deviation 9.8
|
|
Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption
6 month
|
8.4 Sugar sweetened beverages per week
Standard Deviation 9.8
|
11.1 Sugar sweetened beverages per week
Standard Deviation 12.9
|
|
Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption
18 month
|
9.1 Sugar sweetened beverages per week
Standard Deviation 11.7
|
11.3 Sugar sweetened beverages per week
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: baseline, 6 and 18 monthsPopulation: Data reported on all clients with data collected at timepoints. Data was not modeled.
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.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Healthy Diet as Indicated by Fast Food Consumption
Baseline
|
4.3 Fast food per month
Standard Deviation 6.5
|
3.9 Fast food per month
Standard Deviation 7.0
|
|
Healthy Diet as Indicated by Fast Food Consumption
6 month
|
3.7 Fast food per month
Standard Deviation 5.8
|
5.2 Fast food per month
Standard Deviation 10.4
|
|
Healthy Diet as Indicated by Fast Food Consumption
18 month
|
3.8 Fast food per month
Standard Deviation 8.5
|
3.8 Fast food per month
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: baseline and 18 monthsFasting glucose level reported in mg/dl.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Fasting Glucose Level
baseline
|
106.5 mg/dl
Standard Deviation 36.7
|
110.6 mg/dl
Standard Deviation 36.9
|
|
Fasting Glucose Level
18 months
|
106.7 mg/dl
Standard Deviation 45.2
|
117.4 mg/dl
Standard Deviation 60.0
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: 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.
A1c Goal used for analysis was \<7.
Outcome measures
| Measure |
IDEAL Intervention
n=42 Participants
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
|
Control
n=51 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
baseline · Yes
|
27 Participants
|
25 Participants
|
|
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
baseline · No
|
15 Participants
|
26 Participants
|
|
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
6 month · Yes
|
29 Participants
|
23 Participants
|
|
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
6 month · No
|
12 Participants
|
24 Participants
|
|
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
18 month · Yes
|
31 Participants
|
26 Participants
|
|
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)
18 month · No
|
7 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsSelf reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Current Smoking Status
Baseline
|
65 Participants
|
73 Participants
|
|
Current Smoking Status
18 months
|
47 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: baseline and 18 monthsSystolic and diastolic blood pressure measured in mmhg
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Blood Pressure
Baseline systolic blood pressure
|
118.0 mmhg
Standard Deviation 13.0
|
116.5 mmhg
Standard Deviation 12.9
|
|
Blood Pressure
Baseline diastolic blood pressure
|
75.3 mmhg
Standard Deviation 8.2
|
74.9 mmhg
Standard Deviation 9.3
|
|
Blood Pressure
18 month systolic blood pressure
|
120.1 mmhg
Standard Deviation 14.5
|
120.2 mmhg
Standard Deviation 16.2
|
|
Blood Pressure
18 month diastolic blood pressure
|
73.9 mmhg
Standard Deviation 9.2
|
74.7 mmhg
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: 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.
Hypertension goal used for analysis was systolic blood pressure \<140 and diastolic blood pressure \<90. not modeled
Outcome measures
| Measure |
IDEAL Intervention
n=72 Participants
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
|
Control
n=70 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Participants With Hypertension Treated to Goal
18 months · No
|
8 Participants
|
17 Participants
|
|
Participants With Hypertension Treated to Goal
baseline · Yes
|
61 Participants
|
54 Participants
|
|
Participants With Hypertension Treated to Goal
baseline · No
|
11 Participants
|
16 Participants
|
|
Participants With Hypertension Treated to Goal
6 month · Yes
|
62 Participants
|
55 Participants
|
|
Participants With Hypertension Treated to Goal
6 month · No
|
8 Participants
|
13 Participants
|
|
Participants With Hypertension Treated to Goal
18 months · Yes
|
57 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsTotal cholesterol measured in mg/dl
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Total Cholesterol
baseline
|
178.9 mg/dl
Standard Deviation 42.1
|
181.1 mg/dl
Standard Deviation 41.6
|
|
Total Cholesterol
18 month
|
171.8 mg/dl
Standard Deviation 38.3
|
177.7 mg/dl
Standard Deviation 48.7
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsLDL cholesterol measured in mg/dl
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
LDL Cholesterol
baseline
|
101.9 mg/dl
Standard Deviation 36.8
|
101.0 mg/dl
Standard Deviation 33.4
|
|
LDL Cholesterol
18 months
|
93.7 mg/dl
Standard Deviation 33.5
|
97.3 mg/dl
Standard Deviation 35.9
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsHDL cholesterol measured in mg/dl
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
HDL Cholesterol
baseline
|
49.2 mg/dl
Standard Deviation 15.3
|
50.2 mg/dl
Standard Deviation 19.3
|
|
HDL Cholesterol
18 months
|
50.7 mg/dl
Standard Deviation 14.8
|
51.0 mg/dl
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsTriglycerides measured in mg/dl
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Triglycerides
baseline
|
140.2 mg/dl
Standard Deviation 74.3
|
156.6 mg/dl
Standard Deviation 106.7
|
|
Triglycerides
18 months
|
141.0 mg/dl
Standard Deviation 76.9
|
149.0 mg/dl
Standard Deviation 111.1
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: 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.
Goal used for analysis was LDL cholesterol \< 130 mg/dl and Total cholesterol \< 200mg/dl.
Outcome measures
| Measure |
IDEAL Intervention
n=82 Participants
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
|
Control
n=93 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Participants With Dyslipidemia Treated to Goal
Baseline · Yes
|
46 Participants
|
53 Participants
|
|
Participants With Dyslipidemia Treated to Goal
Baseline · No
|
36 Participants
|
40 Participants
|
|
Participants With Dyslipidemia Treated to Goal
6 month · Yes
|
47 Participants
|
55 Participants
|
|
Participants With Dyslipidemia Treated to Goal
6 month · No
|
29 Participants
|
29 Participants
|
|
Participants With Dyslipidemia Treated to Goal
18 month · Yes
|
57 Participants
|
63 Participants
|
|
Participants With Dyslipidemia Treated to Goal
18 month · No
|
18 Participants
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: Participants with data collected at the timepoints
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.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Health Status With Short Form (SF)-12
Physical - Baseline
|
45.3 score on a scale
Standard Deviation 9.1
|
43.9 score on a scale
Standard Deviation 10.0
|
|
Health Status With Short Form (SF)-12
Physical - 6 months
|
45.2 score on a scale
Standard Deviation 9.3
|
44.0 score on a scale
Standard Deviation 9.1
|
|
Health Status With Short Form (SF)-12
Physical - 18 months
|
46.8 score on a scale
Standard Deviation 8.4
|
44.6 score on a scale
Standard Deviation 8.9
|
|
Health Status With Short Form (SF)-12
Mental - Baseline
|
47.3 score on a scale
Standard Deviation 8.3
|
47.9 score on a scale
Standard Deviation 8.5
|
|
Health Status With Short Form (SF)-12
Mental - 6 months
|
48.7 score on a scale
Standard Deviation 8.1
|
48.2 score on a scale
Standard Deviation 7.2
|
|
Health Status With Short Form (SF)-12
Mental - 18 months
|
49.3 score on a scale
Standard Deviation 7.7
|
48.7 score on a scale
Standard Deviation 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: Data reported on all clients with data collected at timepoints. Data was not modeled.
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.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Quality of Life Based on the EUROQOL
Baseline
|
0.75 score on a scale
Standard Deviation 0.20
|
0.74 score on a scale
Standard Deviation 0.20
|
|
Quality of Life Based on the EUROQOL
6 months
|
0.77 score on a scale
Standard Deviation 0.20
|
0.76 score on a scale
Standard Deviation 0.19
|
|
Quality of Life Based on the EUROQOL
18 months
|
0.82 score on a scale
Standard Deviation 0.19
|
0.79 score on a scale
Standard Deviation 0.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: Data reported on all clients with data collected at timepoints. Data was not modeled.
Used medication adherence measure designed by Morisky et al and separately evaluated somatic and psychiatric medications.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Medication Adherence
Psychiatric - 6 months · Good adherence
|
33 Participants
|
43 Participants
|
|
Medication Adherence
Somatic - Baseline · Good adherence
|
45 Participants
|
51 Participants
|
|
Medication Adherence
Somatic - Baseline · Moderate adherence
|
39 Participants
|
41 Participants
|
|
Medication Adherence
Somatic - Baseline · Poor adherence
|
21 Participants
|
26 Participants
|
|
Medication Adherence
Somatic - Baseline · Reported not taking medication type
|
27 Participants
|
19 Participants
|
|
Medication Adherence
Somatic - 6 months · Good adherence
|
39 Participants
|
45 Participants
|
|
Medication Adherence
Somatic - 6 months · Moderate adherence
|
43 Participants
|
41 Participants
|
|
Medication Adherence
Somatic - 6 months · Poor adherence
|
28 Participants
|
25 Participants
|
|
Medication Adherence
Somatic - 6 months · Reported not taking medication type
|
12 Participants
|
14 Participants
|
|
Medication Adherence
Somatic - 18 months · Good adherence
|
49 Participants
|
46 Participants
|
|
Medication Adherence
Somatic - 18 months · Moderate adherence
|
31 Participants
|
43 Participants
|
|
Medication Adherence
Somatic - 18 months · Poor adherence
|
23 Participants
|
22 Participants
|
|
Medication Adherence
Somatic - 18 months · Reported not taking medication type
|
12 Participants
|
10 Participants
|
|
Medication Adherence
Psychiatric - Baseline · Good adherence
|
40 Participants
|
49 Participants
|
|
Medication Adherence
Psychiatric - Baseline · Moderate adherence
|
54 Participants
|
50 Participants
|
|
Medication Adherence
Psychiatric - Baseline · Poor adherence
|
37 Participants
|
37 Participants
|
|
Medication Adherence
Psychiatric - Baseline · Reported not taking medication type
|
1 Participants
|
1 Participants
|
|
Medication Adherence
Psychiatric - 6 months · Moderate adherence
|
50 Participants
|
42 Participants
|
|
Medication Adherence
Psychiatric - 6 months · Poor adherence
|
38 Participants
|
39 Participants
|
|
Medication Adherence
Psychiatric - 6 months · Reported not taking medication type
|
1 Participants
|
1 Participants
|
|
Medication Adherence
Psychiatric - 18 months · Good adherence
|
41 Participants
|
41 Participants
|
|
Medication Adherence
Psychiatric - 18 months · Moderate adherence
|
49 Participants
|
40 Participants
|
|
Medication Adherence
Psychiatric - 18 months · Poor adherence
|
25 Participants
|
38 Participants
|
|
Medication Adherence
Psychiatric - 18 months · Reported not taking medication type
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: 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.
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.
Outcome measures
| Measure |
IDEAL Intervention
n=132 Participants
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
|
Control
n=137 Participants
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Medication Use for Cardiovascular Risk Factors
Hypertension - Baseline · Reported medication for risk factor
|
6 Participants
|
5 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Hypertension - Baseline · Did not report medication for risk factor
|
66 Participants
|
65 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Hypertension - 6 months · Reported medication for risk factor
|
59 Participants
|
55 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Hypertension - 6 months · Did not report medication for risk factor
|
9 Participants
|
12 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Hypertension - 18 months · Reported medication for risk factor
|
51 Participants
|
47 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Hypertension - 18 months · Did not report medication for risk factor
|
7 Participants
|
11 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Diabetes - Baseline · Reported medication for risk factor
|
33 Participants
|
41 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Diabetes - Baseline · Did not report medication for risk factor
|
9 Participants
|
10 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Diabetes - 6 months · Reported medication for risk factor
|
35 Participants
|
41 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Diabetes - 6 months · Did not report medication for risk factor
|
4 Participants
|
6 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Diabetes - 18 months · Reported medication for risk factor
|
29 Participants
|
37 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Diabetes - 18 months · Did not report medication for risk factor
|
5 Participants
|
4 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Dyslipidemia - Baseline · Reported medication for risk factor
|
59 Participants
|
75 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Dyslipidemia - Baseline · Did not report medication for risk factor
|
23 Participants
|
17 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Dyslipidemia - 6 months · Reported medication for risk factor
|
54 Participants
|
68 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Dyslipidemia - 6 months · Did not report medication for risk factor
|
23 Participants
|
17 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Dyslipidemia - 18 months · Reported medication for risk factor
|
49 Participants
|
61 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Dyslipidemia - 18 months · Did not report medication for risk factor
|
20 Participants
|
18 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Smoking cessation - Baseline · Reported medication for risk factor
|
6 Participants
|
1 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Smoking cessation - Baseline · Did not report medication for risk factor
|
59 Participants
|
71 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Smoking cessation - 6 months · Reported medication for risk factor
|
12 Participants
|
3 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Smoking cessation - 6 months · Did not report medication for risk factor
|
48 Participants
|
64 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Smoking cessation - 18 months · Reported medication for risk factor
|
14 Participants
|
3 Participants
|
|
Medication Use for Cardiovascular Risk Factors
Smoking cessation - 18 months · Did not report medication for risk factor
|
41 Participants
|
57 Participants
|
Adverse Events
IDEAL Intervention
Serious events: 29 serious events
Other events: 0 other events
Deaths: 2 deaths
Control
Serious events: 35 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
IDEAL Intervention
n=132 participants at risk
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
|
Control
n=137 participants at risk
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Control
|
|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
7.6%
10/132 • Number of events 14 • baseline to 18 months
|
6.6%
9/137 • Number of events 13 • baseline to 18 months
|
|
General disorders
medical hospitalization
|
15.2%
20/132 • Number of events 22 • baseline to 18 months
|
21.9%
30/137 • Number of events 41 • baseline to 18 months
|
Other adverse events
Adverse event data not reported
Additional Information
Gail Daumit, MD, MHS
Johns Hopkins University School of Medicine
Phone: 410-614-6460
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place