Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Risk of psychiatric hospitalization
研究概览
简要总结
The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients).
详细描述
Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. Traditionally, psychiatry has been sparsely subspecialized in Denmark as well as internationally during the last four decades leaving patients in generalized psychiatric settings. At the same time, demands to clinical skills, research and education have increased, and IT solutions have emerged as a possible way to optimize treatment.
Effects of organizational changes and digital health interventions are rarely investigated scientifically in health care services. This is a randomized controlled trial conducted in the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region.
The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients). Findings from the study will have great impact on future organization and optimization of treatment within psychiatry in Denmark as well as internationally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •All patients with a main diagnosis of bipolar disorder in the five largest psychiatric centers in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hillerød, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup) will be asked for participation
排除标准
- 未提供
结局指标
主要结局
Risk of psychiatric hospitalization
时间窗: During the entire study period of 12 months pr participant
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register
时间窗: During the entire study period of 12 months pr participant
Data on cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
次要结局
- Quality of life according to WHO Quality of Life-BREF (WHOQoL)(Baseline, 6 months and 12 months)
- Perceived stress according to Cohen's Perceived stress scale(Baseline, 6 months and 12 months)
- Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder(Baseline, 6 months and 12 months)
- Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire(Baseline, 6 months and 12 months)
- Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine(During the entire study period of 12 months per participant)
- Clinicians' satisfaction with their work at start and end of the RCT(Baseline and 12 months)
- Patient-reported depressive symptoms according to the major depressive Inventory (MDI)(Baseline, 6 months and 12 months)
- Patient-reported manic symptoms according to the Altman Self-rating Scale for Mania (ASRM)(Baseline, 6 months and 12 months)
- Proportion of patients starting group-based psychoeducation(During the entire study period of 12 months per centre)
研究者
Lars Vedel Kessing
Prof., Principal Investigator
Mental Health Services in the Capital Region, Denmark