Customized Medication Adherence Enhancement for Treating Adults With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00763919
First received: September 29, 2008
Last updated: July 8, 2013
Last verified: July 2013
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 abuse 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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.
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Reporting Groups
  Description
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.

Baseline Measures
    Customized Adherence Enhancement (CAE)  
Number of Participants  
[units: participants]
  43  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     43  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.4  ± 11.2  
Gender  
[units: participants]
 
Female     30  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     43  



  Outcome Measures
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1.  Primary:   Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire   [ Time Frame: baseline and 6 months ]

2.  Primary:   Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire   [ Time Frame: baseline and 6 months ]

3.  Primary:   Change in Treatment Adherence as Measured by the Morisky Scale   [ Time Frame: baseline and 6 months ]

4.  Primary:   Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire   [ Time Frame: baseline and 3 months ]

5.  Primary:   Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire   [ Time Frame: baseline and 3 months ]

6.  Secondary:   Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)   [ Time Frame: baseline and 6 months ]

7.  Secondary:   Change in Attitude as Measured by the Rating of Medication Influences (ROMI)   [ Time Frame: baseline and 6 months ]

8.  Secondary:   Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)   [ Time Frame: baseline and 6 months ]

9.  Secondary:   Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)   [ Time Frame: baseline and 6 months ]

10.  Secondary:   Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)   [ Time Frame: baseline and 6 months ]

11.  Secondary:   Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)   [ Time Frame: baseline and 6 months ]

12.  Secondary:   Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale   [ Time Frame: baseline and 6 months ]

13.  Secondary:   Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)   [ Time Frame: baseline and 6 months ]

14.  Secondary:   Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)   [ Time Frame: baseline and 6 months ]

15.  Secondary:   Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)   [ Time Frame: baseline and 3 months ]

16.  Secondary:   Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)   [ Time Frame: baseline and 3 months ]

17.  Secondary:   Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)   [ Time Frame: baseline and 3 months ]

18.  Secondary:   Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)   [ Time Frame: baseline and 3 months ]

19.  Secondary:   Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale   [ Time Frame: baseline and 3 months ]

20.  Secondary:   Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)   [ Time Frame: baseline and 3 months ]

21.  Secondary:   Change in Attitude as Measured by the Rating of Medication Influences (ROMI)   [ Time Frame: baseline and 3 months ]

22.  Secondary:   Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)   [ Time Frame: baseline and 3 months ]

23.  Secondary:   Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)   [ Time Frame: baseline and 3 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
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.  


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, MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00763919     History of Changes
Other Study ID Numbers: R34 MH078967-02, R34MH078967
Study First Received: September 29, 2008
Results First Received: October 24, 2011
Last Updated: July 8, 2013
Health Authority: United States: Federal Government