Reducing the Burden of Chronic Psychotic Disorders in Tanzania
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CAE + LAI
Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)
干预措施: Customized Adherence Enhancement (Behavioral)
CAE + LAI
Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)
干预措施: Haloperidol Decanoate (Drug)
结局指标
主要结局
Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:
时间窗: 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)
时间窗: 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).
次要结局
- 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))
研究者
Martha Sajatovic, MD
Professor of Psychiatry and of Neurology
Case Western Reserve University