Quality of Life, Treatment Satisfaction, Fear of Hypoglycemia, Eating Habits, Ang Glucose Control in Patients With Type 1 Diabetes: Effects of Structured Group Education Versus Group Care.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 主要终点
- HbA1c (between-group difference in variation from baseline)
研究概览
简要总结
Patients with type 1 diabetes aged 15-65 years without major complications will be randomized either to usual care or to a structured group education program, with 6 four-hour weekly interactive sessions devoted to diabetes management. The principal endpoint will be the variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality of life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.
详细描述
The group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. The intervention is designed for the acquisition of specific skills of self-management. This intervention is provided by a team including physicians, dietitians, and nurses.
The control group will receive individual education during routine clinic visits, following usual care, complying with the recommendations of national (Italian) guidelines.
HbA1c will be assessed every three months for all the duration of the study. The principal endpoint will be variation from baseline of HbA1c at 12 weeks from the beginning of 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes
排除标准
- •serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness)
- •Illiteracy
研究组 & 干预措施
Structured Group education
Six weekly interactive group sessions of 4 hours each, providing information and developing skills for diabetes self-management, including eating habits, food composition, calculation of bolus insulin, information on physical exercise, blood glucose self-monitoring, management of hypoglycemia.
干预措施: Structured group education (Behavioral)
Individual education
Usual care (individual consultations as routinely performed)
干预措施: Individual education (Behavioral)
结局指标
主要结局
HbA1c (between-group difference in variation from baseline)
时间窗: 12 months
次要结局
- Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire)(12 months)
- Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire)(12 months)
- Quality of life (Well-being enquiry in Diabetics [WED] questionnaire)(12 months)
- Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported)(12 months)
研究者
Edoardo Mannucci
Director, Diabetology Unit
Azienda Ospedaliero-Universitaria Careggi