Reducing the Burden of Chronic Psychotic Disorders in Tanzania
Overview
- Phase
- Phase 3
- Intervention
- Customized Adherence Enhancement
- Conditions
- Schizophrenia
- Sponsor
- Case Western Reserve University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.
Detailed Description
In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa. The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.
Investigators
Martha Sajatovic, MD
Professor of Psychiatry and of Neurology
Case Western Reserve University
Eligibility Criteria
Inclusion Criteria
- •Age 18 and older
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Known to have medication treatment adherence problems as identified by the TRQ (20% or more missed medications in past week or past month)
- •Ability to be rated on psychiatric rating scales
- •Willingness to take long-acting injectable medication
- •Able to provide written, informed consent to study participation
Exclusion Criteria
- •History of allergy or intolerance to haloperidol or haloperidol decanoate
- •Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment
- •Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
- •Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
- •Immediate risk of harm to self or others
- •Female who is currently pregnant or breastfeeding
Arms & Interventions
CAE + LAI
Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)
Intervention: Customized Adherence Enhancement
CAE + LAI
Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)
Intervention: Haloperidol Decanoate
Outcomes
Primary Outcomes
Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:
Time Frame: Baseline to 6 month visit
LAI injection adherence will be determined as a count of participants who received LAI injections at the appropriate time (within 7 days of scheduled time).
Tablets Routine Questionnaire (TRQ)
Time Frame: Change from Baseline to 6 month visit
The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 20-30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).
Secondary Outcomes
- Clinical Global Impressions (CGI)(Baseline to 6 month visit)
- Brief Psychiatric Rating Scale (BPRS)(Baseline to 6 month visit)
- Social and Occupational Functioning Scale (SOFAS)(Baseline to 6 month visit)
- Body Mass Index(Baseline to Month 6(week 25))
- ESRS-A Dyskinesia(Baseline to 6 months(25 weeks))
- Drug Attitude Inventory (DAI)(Baseline to 6 month visit)
- ESRS-A Parkinsonism(Baseline to 6 months(25 weeks))
- ESRS-A Dystonia(Baseline to 6 months(25 weeks))
- ESRS-A Akathisia(Baseline to 6 months(25 weeks))