Customized Medication Adherence Enhancement for Adults With Bipolar Disorder (UH CAE)

This study has been completed.
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00830310
First received: January 23, 2009
Last updated: November 29, 2011
Last verified: October 2011
Results First Received: October 24, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Behavioral: Psychoeducation module
Behavioral: Substance use module
Behavioral: Improved communication/rapport with provider module
Behavioral: Medication routines management module

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in January of 2009 and the last participant was enrolled in June of 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Customized Adherence Enhancement (CAE)  
STARTED     43  
COMPLETED     30  
NOT COMPLETED     13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
    Customized Adherence Enhancement (CAE)  
Number of Participants  
[units: participants]
  43  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     42  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  43.1  ± 11.3  
Gender  
[units: participants]
 
Female     28  
Male     15  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     28  
White     15  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     43  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)   [ Time Frame: From Baseline to 3 months ]

2.  Primary:   Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week)   [ Time Frame: From Baseline to 3 months ]

3.  Primary:   Change in Treatment Adherence as Measured by the Morisky Scale   [ Time Frame: From Baseline to 3 months ]

4.  Secondary:   Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)   [ Time Frame: From Baseline to 3 months ]

5.  Secondary:   Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)   [ Time Frame: From Baseline to 3 months ]

6.  Secondary:   Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)   [ Time Frame: From Baseline to 3 months ]

7.  Secondary:   Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)   [ Time Frame: From Baseline to 3 months ]

8.  Secondary:   Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)   [ Time Frame: From Baseline to 3 months ]

9.  Secondary:   Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)   [ Time Frame: From Baseline to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christopher Bialko
Organization: University Hospitals Case Medical Center
phone: 216-286-4362
e-mail: Christopher.Bialko@UHhospitals.org


No publications provided


Responsible Party: Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00830310     History of Changes
Other Study ID Numbers: AZ-IRUSQUET0455, L1195
Study First Received: January 23, 2009
Results First Received: October 24, 2011
Last Updated: November 29, 2011
Health Authority: United States: Institutional Review Board