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Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness

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ClinicalTrials.gov Identifier: NCT02029989
Recruitment Status : Completed
First Posted : January 8, 2014
Results First Posted : May 15, 2014
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Medica Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Hyperlipidemia
Diabetes
Hypertension
Interventions Device: Glucose and lipids
Device: Glycosylated Hemoglobin A1c
Device: Blood Pressure and Heart Rate
Device: Body mass index
Device: Waist and Hip circumference
Behavioral: Comprehensive Medication Management
Enrollment 121
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Pharmacist Comprehensive Medication Management Service (PCS) No Comprehensive Medication Management Services (NCS)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 61 [1] 60
Completed 45 49
Not Completed 16 11
Reason Not Completed
Withdrawal by Subject             1             0
Withdrawal: Fear of needles             1             0
Change of location             2             3
Physician Decision             2             0
Lost to Follow-up             9             7
Death             0             1
Protocol Violation             1             0
[1]
A subject was given the same ID# as withdrawn subject (ID # counted twice) causing N=61 discrepancy.
Arm/Group Title Pharmacist Comprehensive Medication Management Service (PCS) No Comprehensive Medication Management Services (NCS) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
42.32  (11.95) 43.5  (10.62) 42.9  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
36
  60.0%
35
  58.3%
71
  59.2%
Male
24
  40.0%
25
  41.7%
49
  40.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
American Indian or Alaska Native
0
   0.0%
1
   1.7%
1
   0.8%
Asian
1
   1.7%
1
   1.7%
2
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   6.7%
1
   1.7%
5
   4.2%
White
51
  85.0%
53
  88.3%
104
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   6.7%
4
   6.7%
8
   6.7%
Subjects with Metabolic Syndrome based on Point of Care analyses   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
46 42 88
[1]
Measure Description: Metabolic syndrome was identified in 71.2% of the NCS group and in 85.2% of the PCS group. Data was not available for 7 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
Abdominal Obesity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
50 51 101
[1]
Measure Description: Waist Circumference Risk (Males: > 40 inches, Females: > 35 inches) was 86.4% in the NCS group and 87.7% in the PCS Group. Data was not available for 4 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
Total Cholesterol Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
22 25 47
[1]
Measure Description: Risk is defined as greater than 200 mg/dL was 41.7% in the NCS group and 38.6% in the PCS group. Data was not available for 3 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
Low Density Lipoprotein (LDL) Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
13 12 25
[1]
Measure Description: Risk is defined as greater than 130 mg/dL was 24.5% in the NCS group and 25.5% in the PCS group. Data was not available for 20 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
Triglyceride Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
24 32 56
[1]
Measure Description: Risk is defined as greater than 150 mg/dL was 54.2% in the NCS group and 42.1% in the PCS group. Data was not available for 4 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
High Density Lipoprotein (HDL) Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
44 45 89
[1]
Measure Description: Risk is defined as: Males < 40 mg/dL; Females < 50 mg/dL was 75% in the NCS group and 73.3% in the PCS group. Data was not available for 7 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
Hypertension Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
27 25 52
[1]
Measure Description: Risk is defined as blood pressures greater than 130 mmHg systolic and/or greater than 85 mmHg diastolic was 48.1% in the NCS group and 51.9% in the PCS group. Data was not available for 2 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
Diabetes Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
7 6 13
[1]
Measure Description: Risk is defined as glycosylated hemoglobin A1c greater or equal to 6.5% was found in 10.3% of the NCS group and 12.5% of the PCS group. Data was not available for 6 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants.
1.Primary Outcome
Title Metabolic Syndrome (MetS)
Hide Description compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pharmacist Comprehensive Medication Management Service (PCS) No Comprehensive Medication Management Services (NCS)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
85.2 71.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pharmacist Comprehensive Medication Management Service (PCS) No Comprehensive Medication Management Services (NCS)
Hide Arm/Group Description

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

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

All-Cause Mortality
Pharmacist Comprehensive Medication Management Service (PCS) No Comprehensive Medication Management Services (NCS)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pharmacist Comprehensive Medication Management Service (PCS) No Comprehensive Medication Management Services (NCS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pharmacist Comprehensive Medication Management Service (PCS) No Comprehensive Medication Management Services (NCS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Limitations include: 1) Short time duration to achieve metabolic outcome goals, 2) Smaller than anticipated sample size, 3) High number of subjects lost to follow up after 12-months.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Mark E. Schneiderhan
Organization: UMN, College of Pharmacy
Phone: 8452540458
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02029989     History of Changes
Other Study ID Numbers: 090M72212
First Submitted: September 30, 2013
First Posted: January 8, 2014
Results First Submitted: April 15, 2014
Results First Posted: May 15, 2014
Last Update Posted: May 31, 2018