Customized Medication Adherence Enhancement for Adults With Bipolar Disorder

NCT00830310 | Completed Results DMC

• 2 other identifiers: AZ-IRUSQUET0455L1195
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a modular intervention that is intended to improve treatment adherence among individuals with bipolar disorder on atypical antipsychotic therapy who have been identified as having treatment adherence problems.

Conditions

Bipolar Disorder

Keywords

Patient Non-Adherence; Patient Non-Compliance; Patient Nonadherence; Patient Noncompliance; Patient Refusal of Treatment; Refusal of Treatment; Treatment Refusal

Outcome Measures

Primary Outcomes (3)

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

  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.

  From Baseline to 3 months

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

  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.

  From Baseline to 3 months

• Change in Treatment Adherence as Measured by the Morisky Scale

  The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.

  From Baseline to 3 months

Secondary Outcomes (6)

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

  From Baseline to 3 months

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

  From Baseline to 3 months

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

  From Baseline to 3 months

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

  From Baseline to 3 months

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

  From Baseline to 3 months

Study Arms (1)

Customized Adherence Enhancement (CAE)

EXPERIMENTAL

Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the Attitudes toward Mood Stabilizers Questionnaire (AMSQ) and reasons for non-adherence on the Rating of Medication Influences (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.

Behavioral: Psychoeducation module; Behavioral: Substance use module; Behavioral: Improved communication/rapport with provider module; Behavioral: Medication routines management module

Interventions

Psychoeducation module BEHAVIORAL

Individuals will be assigned the psychoeducation module if they are identified as having opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes towards drugs in general, or lack of information about mood stabilizers operationalized as a score of "1" or higher on any of these AMSQ subscales. Additionally, those individuals who are non-adherent/sub-optimally adherent because of stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments will be assigned to participate in the psychoeducation module (ROMI stigma item or complementary/alternative treatment supplemental item).

Customized Adherence Enhancement (CAE)

Substance use module BEHAVIORAL

Individuals will be assigned the substance use module if they endorse the ROMI substance use item or if substance use is identified as problematic on the clinician assessment.

Customized Adherence Enhancement (CAE)

Improved communication/rapport with provider module BEHAVIORAL

Individuals will be assigned the provider communication/rapport module if they are identified as having fear of side effects operationalized as a score of "1" or higher on these AMSQ items. Additionally, those individuals who are non-adherent/suboptimally adherent because of concern regarding change in appearance "appearing medicated" or who experience side-effect-related distress as identified by the ROMI will be assigned the provider communication module.

Customized Adherence Enhancement (CAE)

Medication routines management module BEHAVIORAL

Individuals will be assigned the medication routines management module if they are identified as having difficulties with medication routines operationalized as a score of "1" or higher on this AMSQ sub-scale, or if they are identified as experiencing outside opposition to medications by the ROMI.

Customized Adherence Enhancement (CAE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Bipolar Disorder (BPD) Type I or Type II determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (Sheehan 1998);
• Demonstrated history of poor adherence as per either self-report or clinician report. In this study, self-reported treatment non-adherence will be identified with Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 20% or more of medication within either the past week or past month (those missing 20% or more within past week will be considered to be non-adherent over the past month).
• BPD for at least two years duration;
• Treatment with atypical antipsychotic medication to stabilize mood for at least six months;
• The ability to participate in psychiatric interviews and to give written, informed consent for study participation; and
• Age 18 or older.

You may not qualify if:

• Unable/unwilling to participate in psychiatric interviews based on the clinical opinion of the investigator or the treating clinician. Individuals who are grossly psychotic may be excluded at this point if the treating clinician feels that the prospective participant is unable to participate in the interviews or study procedures;
• Unable/unwilling to give written, informed consent to study participation;
• High risk for suicide (e.g., active suicidal ideation and recent suicide attempt; active suicidal ideation and current intent or plan). In the interest of patient safety, individuals who are acutely suicidal will be excluded from study participation; or
• Individuals who are non-English speaking will be excluded as study assessment tools are not available in other languages and would be impractical to develop in this small, exploratory study.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Patient Compliance; Treatment Refusal

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Christopher Bialko
• Organization: University Hospitals Case Medical Center

Christopher.Bialko@UHhospitals.org

216-286-4362

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University and University Hospitals Case Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 27, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 30, 2014
• Results First Posted: November 24, 2011

Record last verified: 2014-12

Locations

US (1)