Impact of Nurse Case Management on Diabetes-related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- A1c
研究概览
简要总结
This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after 6 months of treatment.
详细描述
The study will be a randomized-control trial recruiting patients with type 2 diabetes in a specialty care setting from two sources:
- referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy
- referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during in-patient care & about to be discharged (Appendix 1).
Patients who meet the inclusion criteria will be randomly assigned into either the NCM group or SC group.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •A1c > 8.0 or
- •BP > 140/90 or
- •LDL cholesterol > 2.0 (72 mg/dl)
排除标准
- •inability to speak English or to be assisted by somebody fluent in English
结局指标
主要结局
A1c
时间窗: 6 months
changes in A1C between NCM vs. SC
diabetes distress (DDS)
时间窗: 6 months
changes in diabetes distress between NCM vs. SC. Diabetes Distress (DDS) will be assessed using the 17-item Diabetes Distress Scale (DDS) developed by Polonsky and colleagues. The DDS measures emotional distress and functioning as it relates to living with diabetes. Responses are scored on a 6-point Likert scale (1=no problem to 6=serious problem). A total score is derived by taking the mean of all items. A score of \< 2 indicate low/no distress, 2 - 2.9 indicates moderate distress, and score of ≥ 3 indicates high distress.
次要结局
- Medication adherence(6 months)
- blood pressure(6 months)
- BMI(6 months)
- Self-management behaviours(6 months)
- Patient motivation(6 months)
- Diabetes-specific Social Support(6 months)
- Depressive Symptoms Severity(6 months)
研究者
Tom Elliott
PI
BCDiabetes.Ca