A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Sports" in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 8
- 主要终点
- Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up
研究概览
简要总结
This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic "diabetes and sports". Primary outcome variable is diabetes-specific empowerment regarding diabetes and sports. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.
详细描述
The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intensive insulin treatment
- •specific interest in "Diabetes and Sports"
- •wish to participate in group education
- •informed consent
- •fluent in reading and speaking German language
排除标准
- •diabetes duration < 4 week
- •severe organic disease (e.g. terminal renal disease, cancer with poor prognosis)
- •current treatment of a mental disease
- •cognitive impairment
- •pregnancy
结局指标
主要结局
Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up
时间窗: Baseline, 2-week follow-up , 6-month follow-up
The Diabetes Empowerment Scale was specifically adjusted to cover the topic "sports". Psychometric criteria for these adjusted scale were evaluated in an independent study.
次要结局
- Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in physical activity on the International Physical Activity Questionnaire (IPAQ) at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in self-care behaviors at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
- Change from baseline in hypoglycemia awareness at the 2-week and 6-month follow-up(baseline, 2-week follow-up, 6-month follow-up)
研究者
Norbert Hermanns
Head of the Research Institut Diabetes Academy Mergentheim
Forschungsinstitut der Diabetes Akademie Mergentheim