Trial Outcomes & Findings for A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs) (NCT NCT00677898)
NCT ID: NCT00677898
Last Updated: 2015-04-27
Results Overview
Guidelines recommend that body mass index be evaluated every 3 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
239 participants
Primary outcome timeframe
1 year
Results posted on
2015-04-27
Participant Flow
Participant milestones
| Measure |
Patient-centered Computerized Tool
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
120
|
|
Overall Study
COMPLETED
|
99
|
102
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs)
Baseline characteristics by cohort
| Measure |
Patient-centered Computerized Tool
n=119 Participants
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 Participants
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
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
|
111 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
120 participants
n=7 Participants
|
239 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearGuidelines recommend that body mass index be evaluated every 3 months
Outcome measures
| Measure |
Patient-centered Computerized Tool
n=119 Participants
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 Participants
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Body Mass Index
|
81.4 percentage of days in the study period
Standard Deviation 22.5
|
76.1 percentage of days in the study period
Standard Deviation 26.2
|
PRIMARY outcome
Timeframe: 1 yearGuidelines recommend that blood pressure be evaluated every 3 months
Outcome measures
| Measure |
Patient-centered Computerized Tool
n=119 Participants
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 Participants
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure
|
83.5 percentage of days in the study period
Standard Deviation 21.8
|
78.5 percentage of days in the study period
Standard Deviation 27.5
|
PRIMARY outcome
Timeframe: 1 yearGuidelines recommend that blood glucose/HbA1c be evaluated every year
Outcome measures
| Measure |
Patient-centered Computerized Tool
n=119 Participants
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 Participants
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Glucose/HbA1c
|
97.7 percentage of days in the study period
Standard Deviation 10.7
|
96.2 percentage of days in the study period
Standard Deviation 14.8
|
PRIMARY outcome
Timeframe: 1 yearGuidelines recommend that LDL cholesterol be evaluated every 2 years
Outcome measures
| Measure |
Patient-centered Computerized Tool
n=119 Participants
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 Participants
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol
|
93.7 percentage of days in study period
Standard Deviation 17.0
|
95.1 percentage of days in study period
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: 1 yearGuidelines recommend that HDL cholesterol be evaluated every 2 years
Outcome measures
| Measure |
Patient-centered Computerized Tool
n=119 Participants
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 Participants
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol
|
94.1 percentage of days in study period
Standard Deviation 16.6
|
95.2 percentage of days in study period
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: 1 yearGuidelines recommend that triglycerides be evaluated every 2 years
Outcome measures
| Measure |
Patient-centered Computerized Tool
n=119 Participants
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 Participants
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides
|
94.1 percentage of days in the study period
Standard Deviation 16.6
|
94.5 percentage of days in the study period
Standard Deviation 15.1
|
Adverse Events
Patient-centered Computerized Tool
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Written Educational Materials
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient-centered Computerized Tool
n=119 participants at risk
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
|
Written Educational Materials
n=120 participants at risk
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
|---|---|---|
|
General disorders
Death
|
1.7%
2/119 • Number of events 2
|
1.7%
2/120 • Number of events 2
|
|
Psychiatric disorders
Psychiatric hospitalization
|
0.00%
0/119
|
0.83%
1/120 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Julie Kreyenbuhl, Pharm.D., Ph.D.
VA VISN 5 Mental Illness Research, Education and Clinical Center
Phone: 410-637-1864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place