Clinical trial NCT00830310: Customized Medication Adherence Enhancement for Adults With Bipolar Disorder
Official title: Customized Adherence Enhancement (CAE) Among Individuals With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Patient Non-Adherence
Patient Non-Compliance
Patient Nonadherence
Patient Noncompliance
Patient Refusal of Treatment
Refusal of Treatment
Treatment Refusal
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2009-01-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study is a pilot, prospective project of the effects of customized adherence enhancement (CAE) when added to the medical management (usual care) of outpatients with bipolar disorder (BPD) who are patients at University Hospitals of Cleveland Case Medical Center, and who are known to be at risk for treatment non-adherence. In the proposed trial, CAE is supported by manuals delivered as a series of four modules whose use will be determined based upon an individual's identified treatment adherence vulnerabilities. The modules are components of a single, customized intervention. Although some participants may receive a different combination or number of modules, the participants are neither analyzed separately as a subpopulation nor compared as subpopulations. Therefore participants are all part of a solitary study arm. The effectiveness of the entire customized intervention system is of interest.

All individuals will continue to receive treatment as usual with their regular provider. Those who are enrolled in the study intervention will participate in a series of 4 in-person meetings with the study interventionist over a 4-week time period and 1-2 telephone follow-ups. These meetings with the interventionist will consist of whatever modules were assigned at baseline that are customized to that particular participant's treatment adherence vulnerabilities. A total of 3 to 4 assessment meetings with the research assistant will occur over a three-month time period.

Primary objective The aim of this project is to test the use of a modular-based intervention in a pilot feasibility, acceptability and preliminary efficacy study of customized adherence enhancement (CAE) in a vulnerable population with BPD. We hypothesize that CAE will be: 1) feasible to administer within a academic medical center; 2) acceptable to participants with BPD; and 3) associated with improvements in treatment adherence.

Secondary objectives Individuals who receive CAE will have improvements in BPD symptoms, global psychopathology, overall treatment attitudes and in functional status.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)
timeFrame: From Baseline to 3 months
measure: Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week)
timeFrame: From Baseline to 3 months
measure: Change in Treatment Adherence as Measured by the Morisky Scale
timeFrame: From Baseline to 3 months
Secondary outcomes:
measure: Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
timeFrame: From Baseline to 3 months
measure: Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)
timeFrame: From Baseline to 3 months
measure: Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)
timeFrame: From Baseline to 3 months
measure: Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)
timeFrame: From Baseline to 3 months
measure: Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)
timeFrame: From Baseline to 3 months
measure: Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
timeFrame: From Baseline to 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University and University Hospitals Case Medical Center
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References: