Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Diabetes Distress at 12 Months
研究概览
简要总结
This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.
详细描述
Diabetes Distress (DD) is the personal, often hidden side of diabetes: it reflects the unique emotional burdens and strains that individuals with diabetes may experience as they struggle to keep blood glucose levels within range. When high, DD can have a major, negative impact on disease management and glycemic control. High DD is characterized by frustration, feeling overwhelmed, and feeling hopeless and discouraged by the unceasing demands of diabetes. DD is also linked to an individual's beliefs, expectations, current life situation, and personal and social resources.
The proposed study is a three-arm, 12-month randomized comparison trial to test the added value of a DD-targeted (TunedIn) intervention vs. a unified DD and management intervention (FixIt), relative to a traditional, educational/behavioral-management intervention (StreamLine). Each of the three programs (arms) will follow a separate, standardized protocol. All participants will receive three months of intervention with nine months of 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase] antibody testing) on intensive insulin treatment;
- •Diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40;
- •Have a recent HbA1c of 7.5% or higher;
- •Not have started to use any new (to the participant) diabetes device (such as an insulin pump or continuous glucose monitor) in the past 6 months;
- •Internet access through a computer or smart phone;
- •Ability to speak/read English.
排除标准
- •No documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe functional deficits, or recent major surgery or hospitalization in the past year.
结局指标
主要结局
Diabetes Distress at 12 Months
时间窗: 12 months
Self-reported diabetes distress across several domains will be assessed using the Type 1 Diabetes Distress Scale (T1-DDS) a validated measure averaged across items (range 1.0-6.0 with higher scores indicating a higher level of diabetes-related distress).
Hemoglobin A1c (HbA1c) at 12 Months
时间窗: 12 months
Hemoglobin A1c (HbA1c) assay laboratory result
次要结局
- Hypoglycemic Episodes at 12 Months(12 months)
- Depression Symptoms at 12 Months(12 months)
- Missed Insulin Boluses at 12 Months(12 months)
- Nonreactivity to Inner Experience at 12 Months(12 months)
- Non-judging of Experience at 12 Months(12 months)
- Personal Control Over Illness at 12 Months(12 months)
- Self-compassion - Diabetes (SCS-D) at 12 Months(12 months)