A Randomized Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change in HbA1c from baseline to 52 weeks follow-up
研究概览
简要总结
Type 1 diabetes is associated with a significant increase in mortality, cardiovascular disease, injuries on eyes and kidneys. These risks are largely dependent on glycemic control. Multiple strategies of achieving good glycemic control exist. Despite this, only about 20 % of patients in Sweden reach the target HbA1c of ≤ 52 mmol/mol.
It is well-known that when the motivation is high, a large proportion of patients reach good glycaemic control with current treatments, e.g. most pregnant women reach a much better glycaemic control. The patient is then motivated to a greater extent in managing the disease, e.g. by carefully dosing insulin and more closely monitoring blood glucose levels.
Moreover, besides lack of motivation, specific psychiatric conditions are well-known barriers in being compliant with treatments such as depression, eating disorders and attention deficit disorders (ADHD). Further, identified specific diabetes-related psychosocial factors include severe fear of hypoglycaemia, diabetes-burnout, unrealistic treatment goals, poor relationship with physician, feelings of powerlessness and treatment skepticism. These parameters can be measured via a diabetes distress scale where a high score is correlated to higher HbA1c.
The majority of outpatient diabetes clinics in Sweden today request the resource of a diabetes-educated psychologist. However, more evidence is needed from randomized multicentre trials whether such a resource would help to improve HbA1c, reduce diabetes-related distress and improve quality of life.
The primary aim of the current study is to evaluate whether the assistance of a diabetes-educated psychologist in the diabetes care of patients with type 1 diabetes improves HbA1c. Secondary endpoints include studying its influence on diabetes-related distress and quality of life. The study is a 1 year randomized trial where the intervention group will meet with a diabetes-educated psychologist in addition to conventional care.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
- •Clinical diagnosis of Type 1 diabetes
- •Adult patients over 18 years of age
- •HbA1c > 62 mmol/mol
排除标准
- •Type 2 diabetes
- •Diabetes duration <1 year
- •Long-term Systemic glucocorticoid treatment during the last 3 months
- •Changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
- •Current or planned pregnancy or breastfeeding during the next 12 months
- •Planned move during the next 12 months making it not possible to participate in study activities
- •Other reason determined by the investigator not being appropriate for participation
结局指标
主要结局
Change in HbA1c from baseline to 52 weeks follow-up
时间窗: 52 weeks
次要结局
- Change in Diabetes distress scale score from baseline to week 52(52 weeks)
- Change in quality of life score (ADDQoL) from baseline to week 52(52 weeks)
- score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52(52 weeks)