Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Glycosylated Hemoglobin (HbA1c) at 60 Weeks
研究概览
简要总结
This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. The information gained from the randomized trial will be supplemented with reports from participants about their experiences of trying to improve illness self-management. Improvements in self-management should result in a reduction of psychiatric symptoms and improvements in functioning and physical health.
详细描述
This project will test a novel intervention, Targeted Training in Illness Management (TTIM), intended to improve both serious mental illness (SMI) and diabetes mellitus (DM) self-management in 100 individuals with SMI-DM vs. 100 individuals with SMI-DM receiving treatment as usual (TAU). The intervention will be conducted in a safety-net health system primary care setting and will be conducted as a randomized controlled trial (RCT). The primary effects of TTIM will be assessed with respect to SMI symptoms, Functional Status/Role Impairment, General Health Status, and DM outcomes. Secondary outcomes include adherence to psychotropic and DM medication, and engagement in healthy behaviors.
This assessment will include quantitative assessment of facilitators/barriers targeted by the proposed intervention as well as a supplemental qualitative assessment. The qualitative assessments will include input from patients and interventionists. Specific aims for the qualitative analysis are to validate findings from the RCT, expand understanding of "key active ingredients" of TTIM, and provide information to inform future studies on individuals with SMI and related medical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression
- •Have DM based upon either previous diagnosis or laboratory values
- •Be ≥ 18 years of age
- •Be able to communicate in English
- •Be able to provide written, informed consent to participation.
排除标准
- •Actively suicidal/homicidal
- •Unable to be rated on study rating scales
- •Unable to provide informed consent.
研究组 & 干预措施
Targeted Training in Illness Management (TTIM)
Participants in this arm will receive the TTIM intervention as well as receiving regular treatment for their DM and SMI from their normal medical and mental health care providers.
干预措施: Targeted Training in Illness Management (TTIM) (Behavioral)
Treatment As Usual (TAU)
Participants in this arm will continue to receive Treatment as Usual from their usual medical and mental health care providers. They will not receive any intervention.
结局指标
主要结局
Glycosylated Hemoglobin (HbA1c) at 60 Weeks
时间窗: 60 weeks
Clinical Global Impression (CGI) at 60 Weeks
时间窗: 60 weeks
The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.
Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks
时间窗: 60 weeks
The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.
Brief Psychiatric Rating Scale (BPRS) at 60 Weeks
时间窗: 60 weeks
The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.
Global Assessment of Functioning (GAF) at 60 Weeks
时间窗: 60 weeks
The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.
Sheehan Disability Scale (SDS) at 60 Weeks
时间窗: 60 weeks
The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.
Systolic Blood Pressure at 60 Weeks
时间窗: 60 weeks
SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component
时间窗: 60 weeks
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
Body Mass Index (BMI) at 60 Weeks
时间窗: 60 weeks
SF-36 Health Survey at 60 Weeks; Physical Health Component
时间窗: 60 weeks
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
次要结局
- Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks(60 weeks)
- Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks(60 weeks)
- Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks(60 weeks)
- Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks(60 weeks)
- Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks(60 weeks)
- Tablets Routine Questionnaire (TRQ) at 60 Weeks(60 weeks)
- Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks(60 weeks)
- Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks(60 weeks)
研究者
Martha Sajatovic, MD
Professor of Psychiatry
Case Western Reserve University