A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care. A Pragmatic Cluster Randomised Controlled Trial in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour changes. In Denmark, the tendency is that nurses in general practice provide a large part of type 2 diabetes care.
Observational studies support Self-determination Theory by finding autonomous motivation and perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes. Hence, research is needed to develop and test interventions that are autonomy supportive.
Aim To develop a training course for practice-nurses in autonomy support in patients with type 2 diabetes, and to evaluate the effect on patient outcomes.
Methods The development of the intervention was based on literature research and expert meetings. The intervention is evaluated in a cluster randomised controlled trial with 40 Danish general practices,
- where nurses, before enrolment in the study, provided consultations to patients with type 2 diabetes,
- and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.
The patients will be followed 15 months from nurse-participation in the course. Data will be obtained from registers and patient-questionnaires. The hypothesis is that patients with type 2 diabetes regardless of education level, age, and gender will benefit from the intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The intervention-study comprises 40 general practices were:
- •more than 50% of the patients with type 2 diabetes, who had participated in diabetes-consultations during the last year from the invitation-date to the project, were seen by a nurse at least once, stated by the practice. The diabetes-consultation should not only include examinations (blood tests and blood pressure measurement), but should also include communication about living with type 2 diabetes ;
- •enrollment in the project before registration deadline (three weeks after invitation).
- •Patients with diabetes, alive and affiliated the practices by May 2011, were identified in a a validated diabetes database based on health registers; The national Patient Registry, The national Health Insurance Service registry, the prescription database and the laboratory database in the county.
排除标准
- 未提供
结局指标
主要结局
HbA1c
时间窗: Last measurement within 12 months before - and 15 months after nurse participation in the course
Collected from registers (historical data - not measured as a part of this study)
次要结局
- HDL-cholesterol(Last measurement within 12 months before - and 15 months after nurse participation in the course)
- LDL-cholesterol(Last measurement within 12 months before - and 15 months after nurse participation in the course)
- Perceived autonomy support (HCCQ)(15 months from nurse participation in the course)
- Type of motivation (TSRQ)(15 months from nurse participation in the course)
- Perceived competence (PCS)(15 months from nurse participation in the course)
- Total-cholesterol(Last measurement within 12 months before - and 15 months after nurse participation in the course)
- Self-rated health (SF-12)(15 months from nurse participation in the course)
- Problem Areas In Diabetes scale (PAID)(15 months from nurse participation in the course)