Bipolar DisorderUH CAENCT00830310
Customized Medication Adherence Enhancement for Adults With Bipolar Disorder
A study testing Psychoeducation module, Substance use module and Improved communication/rapport with provider module in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Psychoeducation module, Substance use module and Improved communication/rapport with provider module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Customized Adherence Enhancement (CAE) Among Individuals With Bipolar Disorder
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Psychoeducation module, Substance use module, Improved communication/rapport with provider module, Medication routines management module
- Keywords
- Patient Non-Adherence, Patient Non-Compliance, Patient Nonadherence, Patient Noncompliance, Patient Refusal of Treatment, Refusal of Treatment, Treatment Refusal
- Medical subject headings
- Bipolar Disorder, Patient Compliance, Treatment Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation moduleBehavioural
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).
Substance use moduleBehavioural
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.
Improved communication/rapport with provider moduleBehavioural
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.
Medication routines management moduleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychoeducation module; Behavioral: Substance use module; Behavioral: Improved communication/rapport with provider module; Behavioral: Medication routines management module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Baseline to 3 months
Secondary outcomes (6)
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Measured: From Baseline to 3 months
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Measured: From Baseline to 3 months
Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)
The minimum score is 0 and the maximum score is 10. A higher score implies a better attitude.
Measured: From Baseline to 3 months
Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)
The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.
Measured: From Baseline to 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)
The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.
Measured: From Baseline to 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.
Measured: From Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Martha Sajatovic, University Hospitals Cleveland Medical Center
- Investigators
- Martha Sajatovic, MD, Principal investigator, Case Western Reserve University and University Hospitals Case Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830310
- Sponsor's protocol ID
- AZ-IRUSQUET0455
- Other IDs
- L1195
- Acronym
- UH CAE
- Status last verified
- Dec 2014
- First submitted
- 23 Jan 2009
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Adherence Enhancement (CAE) Among Individuals With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00830310
- Acronym / sponsor ID
- UH CAE / AZ-IRUSQUET0455
- Conditions
- Bipolar Disorder
- Keywords
- Patient Non-Adherence, Patient Non-Compliance, Patient Nonadherence, Patient Noncompliance, Patient Refusal of Treatment, Refusal of Treatment, Treatment Refusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 24 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Customized Adherence Enhancement (CAE) | Experimental | Behavioral: Psychoeducation module, Behavioral: Substance use module, Behavioral: Improved communication/rapport with provider module, Behavioral: Medication routines management moduleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation moduleIndividuals 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). | Behavioural | Customized Adherence Enhancement (CAE) |
| Substance use moduleIndividuals 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. | Behavioural | Customized Adherence Enhancement (CAE) |
| Improved communication/rapport with provider moduleIndividuals 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. | Behavioural | Customized Adherence Enhancement (CAE) |
| Medication routines management moduleIndividuals 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. | Behavioural | Customized Adherence Enhancement (CAE) |
Primary outcome
Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)
Time frame: From Baseline to 3 months
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
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
The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.
6 secondary outcomes
Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)
Time frame: From Baseline to 3 months
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)
Time frame: From Baseline to 3 months
Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)
Time frame: From Baseline to 3 months
Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)
Time frame: From Baseline to 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)
Time frame: From Baseline to 3 months
Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)
Time frame: From Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Sajatovic, MD principal investigator
Case Western Reserve University and University Hospitals Case Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation module, Substance use module and Improved communication/rapport with provider module in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month) (time frame: From Baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.