Trial Outcomes & Findings for Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder (NCT NCT00763919)
NCT ID: NCT00763919
Last Updated: 2014-10-20
Results Overview
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
COMPLETED
NA
43 participants
baseline and 6 months
2014-10-20
Participant Flow
Participant milestones
| Measure |
Customized Adherence Enhancement (CAE)
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Customized Adherence Enhancement (CAE)
n=43 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=28 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire
|
-27.8 units on a scale
Standard Error 6.5
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=28 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire
|
-20.6 units on a scale
Standard Error 8.2
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=28 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Treatment Adherence as Measured by the Morisky Scale
|
-1.7 units on a scale
Standard Error .29
|
PRIMARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=33 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire
|
-28.9 units on a scale
Standard Error 6.0
|
PRIMARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=33 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire
|
-21.8 units on a scale
Standard Error 6.8
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=31 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)
|
-4.1 units on a scale
Standard Error 3.2
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=30 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Attitude as Measured by the Rating of Medication Influences (ROMI)
|
-1.8 units on a scale
Standard Error .86
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=30 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)
|
-2.5 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=30 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
|
-4.9 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=30 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
|
-8.0 units on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=30 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)
|
-.90 units on a scale
Standard Error .25
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=30 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale
|
6.7 units on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=27 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)
|
.48 units on a scale
Standard Error 2.2
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants for analysis was based on all available data at the six month time point.
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=27 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)
|
6.9 units on a scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=32 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)
|
-1.4 units on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=32 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
|
-2.8 units on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=32 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
|
-6.6 units on a scale
Standard Error 2.4
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=32 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)
|
-.47 units on a scale
Standard Error .27
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=32 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale
|
3.5 units on a scale
Standard Error .39
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=33 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)
|
-3.2 units on a scale
Standard Error .62
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=33 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Attitude as Measured by the Rating of Medication Influences (ROMI)
|
-1.6 units on a scale
Standard Error .88
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=32 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)
|
1.1 units on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Number of participants for analysis was based on all available data at the three month time point.
The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.
Outcome measures
| Measure |
Customized Adherence Enhancement (CAE)
n=32 Participants
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)
|
3.8 units on a scale
Standard Error 2.4
|
Adverse Events
Customized Adherence Enhancement (CAE)
Serious adverse events
| Measure |
Customized Adherence Enhancement (CAE)
n=43 participants at risk
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Psychiatric disorders
worsening mania
|
4.7%
2/43 • Number of events 2 • 2 years and 3 months
|
|
Social circumstances
death
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
|
Psychiatric disorders
worsening anxiety/panic attack
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
|
Psychiatric disorders
suicidal thoughts
|
4.7%
2/43 • Number of events 2 • 2 years and 3 months
|
|
Social circumstances
incarcerated
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
|
Skin and subcutaneous tissue disorders
boils beneath arms (hydronitis)
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
Other adverse events
| Measure |
Customized Adherence Enhancement (CAE)
n=43 participants at risk
Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
|
|---|---|
|
Psychiatric disorders
Suicidal thoughts without plan
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
|
Psychiatric disorders
mental instability
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
|
Psychiatric disorders
Worsening depression
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
|
Psychiatric disorders
Worsening mania
|
2.3%
1/43 • Number of events 1 • 2 years and 3 months
|
Additional Information
Christopher Bialko
University Hospitals Case Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place