Trial Outcomes & Findings for Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness (NCT NCT02029989)
NCT ID: NCT02029989
Last Updated: 2024-04-04
Results Overview
compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
Baseline
Results posted on
2024-04-04
Participant Flow
Subjects were recruited at three community mental health sites in Minnesota site (Human Development Center - Duluth, MN; Range Mental Health Center - Hibbing, MN; Family Life Mental Health Center - Coon Rapids, MN; with subjects assigned to receive either pharmacist CMM services (PCS) or no pharmacist CMM services (NCS)/Control Group.
Participant milestones
| Measure |
Pharmacist Comprehensive Medication Management Service (PCS)
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
|
No Comprehensive Medication Management Services (NCS)
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
COMPLETED
|
45
|
49
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
Reasons for withdrawal
| Measure |
Pharmacist Comprehensive Medication Management Service (PCS)
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
|
No Comprehensive Medication Management Services (NCS)
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Withdrawal: Fear of needles
|
1
|
0
|
|
Overall Study
Change of location
|
2
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness
Baseline characteristics by cohort
| Measure |
Pharmacist Comprehensive Medication Management Service (PCS)
n=60 Participants
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
|
No Comprehensive Medication Management Services (NCS)
n=60 Participants
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.32 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 10.62 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Subjects with Metabolic Syndrome based on Point of Care analyses
|
46 participants
n=5 Participants
|
42 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Abdominal Obesity
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Total Cholesterol Risk
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Low Density Lipoprotein (LDL) Risk
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Triglyceride Risk
|
24 participants
n=5 Participants
|
32 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
High Density Lipoprotein (HDL) Risk
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Hypertension Risk
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Diabetes Risk
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baselinecompare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline
Outcome measures
| Measure |
Pharmacist Comprehensive Medication Management Service (PCS)
n=60 Participants
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
|
No Comprehensive Medication Management Services (NCS)
n=60 Participants
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
|
|---|---|---|
|
Metabolic Syndrome (MetS)
|
85.2 percentage of participants
|
71.2 percentage of participants
|
Adverse Events
Pharmacist Comprehensive Medication Management Service (PCS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Comprehensive Medication Management Services (NCS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place