Group Versus Individual Care in Patients With Long Standing Type 1 and Type 2 Diabetes: Non Inferiority in a One Year Prospective Study in a Tertiary Diabetes Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- change in in Hba1c levels
研究概览
简要总结
In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.
详细描述
in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Diagnosis of type 1 or type 2 diabetes
- •Fluency in Hebrew
- •Attendance at least for the second time at the diabetes clinic
- •Follow up of at least one year by a general practitioner
- •Willingness to participate in the study and to give informed consent.
排除标准
- •Uncontrolled psychiatric diseases
- •Active cancer
- •Pregnancy
研究组 & 干预措施
group care with empowerment model
4 group visits a year according to empowerment model in a tertiary diabetes clinic
干预措施: group care with Empowerment model (Behavioral)
individual usual care
individual visits according to disponibility in the diabetes clinic and needs of the patients
干预措施: group care with Empowerment model (Behavioral)
结局指标
主要结局
change in in Hba1c levels
时间窗: one year from date of randomization
Collection of data at start and after one year
次要结局
- change in scores of diabetes specific questionnaire(one year from date of randomization)
- change in BMI in kg/m2(one year from date of randomization)
- change in non HDL Cholesterol(one year from date of randomization)