Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness
Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02029989
Collaborator
Medica Foundation (Other)
121
3
2
24
40.3
1.7
Study Details
Study Description
Brief Summary
The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome. Subjects were also randomized to either an Extended Treatment Group (ETG) defined by receiving comprehensive medication management (CMM) pharmacist interventions or a Usual Treatment Group (UTG) receiving no CMM interventions. All subjects were recruited from three community mental health clinic settings in Minnesota.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
It is well recognized that patients on antipsychotic agents with mental illness continue to be affected by a severe health disparity due to lack of adequate metabolic monitoring.1-7 A major healthcare concern is the life-expectancy decrease of ~25 years for patients with illnesses such as schizophrenia as compared with the general population. Equally concerning is that patients with severe persistent mental illness (SPMI) continue to have inadequate integration of care between psychiatry and medicine. Because of the difficulty getting patients to primary care or hospital based laboratories, the use of capillary blood, point-of-care tests (POCT) to monitor glucose and lipids in addition to vital signs and other anthropometric measurements in community mental health centers might prove beneficial. It is highly likely that this advanced level of screening in the mental health setting may lead to identifying new metabolic abnormalities or improved treatment with careful monitoring of previously diagnosed metabolic syndrome, diabetes, and/or hypertension in antipsychotic treated patients. It is hypothesized that if metabolic abnormalities are identified; then providing pharmacist CMM consultative services would reduce medication related problems by improving medication adherence, coordination of care between psychiatry and primary care, and outcomes in metabolic indices.
Study Design
Study Type:
Interventional
Actual Enrollment
:
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Can Point-of-care Testing (POCT) and Assistance From Comprehensive Medication Management (CMM) Pharmacists Improve Early Detection and Management of Metabolic Syndrome in Patients Treated With Antipsychotic Medications?
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Feb 1, 2012
Actual Study Completion Date
:
Feb 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Extended Treatment Group 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 |
Device: Glucose and lipids
Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
Other Names:
Device: Glycosylated Hemoglobin A1c
Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Other Names:
Device: Blood Pressure and Heart Rate
Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
Other Names:
Device: Body mass index
Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
Other Names:
Device: Waist and Hip circumference
Measurement for Central Obesity
Waist and Hip circumference
Other Names:
Behavioral: Comprehensive Medication Management
Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
Other Names:
|
| Active Comparator: Usual Treatment Group Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference |
Device: Glucose and lipids
Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
Other Names:
Device: Glycosylated Hemoglobin A1c
Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Other Names:
Device: Blood Pressure and Heart Rate
Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
Other Names:
Device: Body mass index
Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
Other Names:
Device: Waist and Hip circumference
Measurement for Central Obesity
Waist and Hip circumference
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Metabolic Syndrome (MetS) [Baseline]
compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
English speaking
-
Age 18-64
-
Competent to understand and make medical choices independently
Exclusion Criteria:
- Currently or previously seen by a CMM pharmacist
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Family Life Mental Health Center | Coon Rapids | Minnesota | United States | 55433 |
| 2 | Human Development Center | Duluth | Minnesota | United States | 55805 |
| 3 | Range Mental Health Center | Hibbing | Minnesota | United States | 55746 |
Sponsors and Collaborators
- University of Minnesota
- Medica Foundation
Investigators
- Principal Investigator: Mark E Schneiderhan, PharmD, University of Minnesota, College of Pharmacy, Duluth
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02029989
Other Study ID Numbers:
- 090M72212
First Posted:
Jan 8, 2014
Last Update Posted:
May 31, 2018
Last Verified:
Apr 1, 2018
Keywords provided by University of Minnesota
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail |
| Arm/Group Title | Pharmacist Comprehensive Medication Management Service (PCS) | No Comprehensive Medication Management Services (NCS) |
|---|---|---|
| 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 | 60 |
| COMPLETED | 45 | 49 |
| NOT COMPLETED | 16 | 11 |
Baseline Characteristics
| Arm/Group Title | Pharmacist Comprehensive Medication Management Service (PCS) | No Comprehensive Medication Management Services (NCS) | Total |
|---|---|---|---|
| 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 Participants | 60 | 60 | 120 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
42.32
(11.95)
|
43.5
(10.62)
|
42.9
(11.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
36
60%
|
35
58.3%
|
71
59.2%
|
| Male |
24
40%
|
25
41.7%
|
49
40.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
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%
|
| Black or African American |
4
6.7%
|
1
1.7%
|
5
4.2%
|
| White |
51
85%
|
53
88.3%
|
104
86.7%
|
| More than one race |
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 (participants) [Number] | |||
| Number [participants] |
46
76.7%
|
42
70%
|
88
73.3%
|
| Abdominal Obesity (participants) [Number] | |||
| Number [participants] |
50
83.3%
|
51
85%
|
101
84.2%
|
| Total Cholesterol Risk (participants) [Number] | |||
| Number [participants] |
22
36.7%
|
25
41.7%
|
47
39.2%
|
| Low Density Lipoprotein (LDL) Risk (participants) [Number] | |||
| Number [participants] |
13
21.7%
|
12
20%
|
25
20.8%
|
| Triglyceride Risk (participants) [Number] | |||
| Number [participants] |
24
40%
|
32
53.3%
|
56
46.7%
|
| High Density Lipoprotein (HDL) Risk (participants) [Number] | |||
| Number [participants] |
44
73.3%
|
45
75%
|
89
74.2%
|
| Hypertension Risk (participants) [Number] | |||
| Number [participants] |
27
45%
|
25
41.7%
|
52
43.3%
|
| Diabetes Risk (participants) [Number] | |||
| Number [participants] |
7
11.7%
|
6
10%
|
13
10.8%
|
Outcome Measures
| Title | Metabolic Syndrome (MetS) |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pharmacist Comprehensive Medication Management Service (PCS) | No Comprehensive Medication Management Services (NCS) |
|---|---|---|
| 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 |
| Measure Participants | 60 | 60 |
| Number [percentage of participants] |
85.2
142%
|
71.2
118.7%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Pharmacist Comprehensive Medication Management Service (PCS) | No Comprehensive Medication Management Services (NCS) | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Pharmacist Comprehensive Medication Management Service (PCS) | No Comprehensive Medication Management Services (NCS) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pharmacist Comprehensive Medication Management Service (PCS) | No Comprehensive Medication Management Services (NCS) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | ||
Limitations/Caveats
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.
More Information
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 |
| meschnei@d.umn.edu |
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02029989
Other Study ID Numbers:
- 090M72212
First Posted:
Jan 8, 2014
Last Update Posted:
May 31, 2018
Last Verified:
Apr 1, 2018