RCT on Care Manager Organization for Management of Mild-moderate Depression in the Primary Care Setting, Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II)
研究概览
简要总结
The aim of the project is to explore if a complementary addition of a care manager for depression treatment in the primary care setting has positive effects concerning reduction of the patients' depressive symptoms as well as improvement of daily function and quality of life in a short- and long-term perspective compared with the traditional Swedish primary care organization. The aim is also to evaluate the care manager function in a health economic perspective.
The specific aims are to develop and evaluate an evidence-based care manager program for patients with mild to moderate depression and to compare the evidence-based care manager program to treatment as usual (TAU) in terms of their short- and long-term effects on symptom remission, treatment adherence, care satisfaction, and self-efficacy as well as to perform a cost - effectiveness analysis of the care manager program, i.e. to evaluate the effects of the program on patients' health in relation to the running costs of the program.
详细描述
Methods The research questions will be tested in a randomised controlled trial with follow ups 3 and 6 months in the primary care setting in cooperation between universities of Gothenburg, Karolinska Institute and primary care centres (PCC) of regions/county councils of Västra Götaland, and Dalarna.
Design A cluster randomized controlled trial of two groups (intervention and control). Randomization will be at the level of the primary care centers (PCCs).
Population of study Patients aged 18 and up that visit one of 20 different urban and rural PCCs.
Randomization All PCCs in the participating regions without employed onsite mental health professionals are invited to participate in the study. Around twenty practices will be matched into 10 blocks by depression treatment practices, thereafter 1 practice from each block will be randomly assigned to receive the care manager intervention program.
Intervention At the intervention practices, a district nurse will apply around 15-25% of working time as care coordinator for management of care for the patients with depression. Before patient recruitment begins, physicians and the nurse/district nurse (care manager) will participate in sessions for training in providing clinical services (patient information and education on patient's preferred treatment, assessment of patient's depressive symptoms and regular telephone contacts, follow up visits etc).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed mild-moderate depression,
- •18 - 80 years,
- •attending primary care center
排除标准
- •schizophrenia,
- •abuse/addiction,
- •psychosis,
- •bipolar syndrome,
- •suicidal ideation or earlier suicide attempt,
- •ongoing deep depression,
- •generalized anxiety syndrome,
- •not communicable in Swedish
结局指标
主要结局
Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II)
时间窗: 0- 6 months
Self-reported level of depressive symptoms measured by Beck Depression Inventory II
次要结局
- Change of level of Work Ability (Self-reported level of perceived work ability measured by Work Ability Index)(0 - 6 months)
- Sick-listing (Amount of sick-listing days during 0-6 months observation period)(6 months)
- Change of level of job strain (Perception of job strain measured by Karasek Job Strain Model)(0-6 months)
- Change of level of Quality of Life (Self-reported level of perceived Quality of Life measured by EQ-5D)(0- 6 months)