Trial Outcomes & Findings for Customized Medication Adherence Enhancement for Adults With Bipolar Disorder (NCT NCT00830310)

NCT ID: NCT00830310

Last Updated: 2014-12-30

Results Overview

Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment. The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: From Baseline to 3 months
• Results posted on: 2014-12-30

Participant Flow

Recruitment began in January of 2009 and the last participant was enrolled in June of 2010.

Participant milestones

Measure	Customized Adherence Enhancement (CAE) Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.
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 Adults With Bipolar Disorder

Baseline characteristics by cohort

Measure	Customized Adherence Enhancement (CAE) n=43 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	43.1 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 3 months

Population: Number of participants for analysis was based on all available data at the three month time point.

Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment.

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=30 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)

-23.6 percentage of medication not taken Standard Error 4.5

PRIMARY outcome

Timeframe: From Baseline to 3 months

Population: Number of participants for analysis was based on all available data at the three month time point.

Treatment nonadherence is measured as a percentage of medications not taken within the past week at time of assessment.

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=30 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week)

-17.8 percentage of medications not taken Standard Error 5.7

PRIMARY outcome

Timeframe: From Baseline to 3 months

Population: 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 4. A higher score implies poorer treatment adherence.

Outcome measures

Measure

Customized Adherence Enhancement (CAE) n=30 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Treatment Adherence as Measured by the Morisky Scale

-1.4 units on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: From Baseline to 3 months

Population: Number of participants for analysis was based on all available data at the three month time point.

The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

Outcome measures

Measure

Customized Adherence Enhancement (CAE) n=29 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)

-3.7 units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: From Baseline to 3 months

Population: Number of participants for analysis was based on all available data at the three month time point.

The minimum possible 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 will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)

-0.67 units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: From Baseline to 3 months

Population: 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 better attitude.

Outcome measures

Measure

Customized Adherence Enhancement (CAE) n=30 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)

1.7 units on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: From Baseline to 3 months

Population: 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=29 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)

8.2 units on a scale Standard Error 2.2

SECONDARY outcome

Timeframe: From Baseline to 3 months

Population: 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=29 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)

-2.4 units on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: From Baseline to 3 months

Population: 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=29 Participants Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)

-3.4 units on a scale Standard Error 1.5

Adverse Events

Customized Adherence Enhancement (CAE)

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Customized Adherence Enhancement (CAE) n=43 participants at risk Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.
Musculoskeletal and connective tissue disorders broken vertebrae	2.3% 1/43 • Number of events 1
Psychiatric disorders worsening depression	2.3% 1/43 • Number of events 1
Cardiac disorders congestive heart failure	2.3% 1/43 • Number of events 1
Psychiatric disorders worsening mania	2.3% 1/43 • Number of events 2

Other adverse events

Measure

Customized Adherence Enhancement (CAE) n=43 participants at risk Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI. Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant. An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules.

Psychiatric disorders substance abuse

2.3% 1/43 • Number of events 1

Additional Information

Christopher Bialko

University Hospitals Case Medical Center

Phone: 216-286-4362

Email: Christopher.Bialko@UHhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60