Effects of Medisinstart for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 19
- 主要终点
- HbA1c
研究概览
简要总结
Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control.
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
- None
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
- •Extracted a new drug/active substance (A10A/A10B) for type 2 diabetes
- •Age ≥ 18 years
- •The drugs are administered by the patient/relatives
- •Good command of Norwegian, both written and spoken
排除标准
- •Inability to understand and/or complete consent forms, questionnaires and/or other patient-oriented materials
- •Not able to attend physical appointments in the pharmacy
- •Not given written consent to participate in the study
- •Diabetes medication is administered by a healthcare professional
- •Known pregnancy
- •HbA1c is unsuitable as an average measure of blood glucose at baseline
- •Received initiation of medication for type 2 diabetes within the last year
- •Ongoing participation in other studies involving similar interventions to increase adherence and ensure correct medication use
研究组 & 干预措施
Control
Medisinstart
干预措施: Medisinstart (Other)
结局指标
主要结局
HbA1c
时间窗: At baseline and 12 months after initation of the new medication for type 2 diabetes.
Change in HbA1c-level from baseline to 12 months after initiation of a new medication for type 2 diabetes.
HbA1c
时间窗: At baseline and 6 months after initation of the new medication for type 2 diabetes.
Change in HbA1c-level from baseline to 6 months after initiation of a new medication for type 2 diabetes.
次要结局
- Frequency of medication-related problems(At the first and second Medisinstart consultations and 12 months after initiation of the new medication for type 2 diabetes)
- Self-reported adherence(6 and 12 months after initiation of the new medication for type 2 diabetes)
- Patients' beliefs about their medicines(At baseline and 6 months after initation of the new medication for type 2 diabetes)
- Diabetes Treatment Satisfaction(At baseline and 6 and 12 months after initiation of the new medication for type 2 diabetes)
- Diabetes Self-Management(12 months after initiation of the new medication for type 2 diabetes)