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
  Purpose

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.


Condition Intervention
Bipolar Disorder
Behavioral: Psychoeducation module
Behavioral: Substance use module
Behavioral: Improved communication/rapport with provider module
Behavioral: Medication routines management module

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Customized Adherence Enhancement (CAE) Among Individuals With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]

    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.


  • Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]

    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.


  • Change in Treatment Adherence as Measured by the Morisky Scale [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.


Secondary Outcome Measures:
  • Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
    The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

  • Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
    The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.

  • Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 10. A higher score implies a better attitude.

  • Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
    The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.

  • Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
    The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.

  • Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]
    The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.


Enrollment: 43
Study Start Date: January 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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
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).
Behavioral: Substance use module
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.
Behavioral: Improved communication/rapport with provider module
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.
Behavioral: Medication routines management module
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830310

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Case Western Reserve University
Investigators
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University and University Hospitals Case Medical Center
  More Information

No publications provided

Responsible Party: Martha Sajatovic, Professor of Psychiatry, 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

Keywords provided by University Hospitals of Cleveland:
Patient Non-Adherence
Patient Non-Compliance
Patient Nonadherence
Patient Noncompliance
Patient Refusal of Treatment
Refusal of Treatment
Treatment Refusal

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014