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
- 1
- 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
研究组 & 干预措施
Training course for practice nurses in autonomy support
干预措施: Training course for practice nurses in autonomy support (Behavioral)
Control
Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.
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)