QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- HbA1c at Month 6
研究概览
简要总结
Glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. The investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. The investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.
详细描述
The goal of this study is to assess the feasibility and efficacy of usual care with the QBSafe intervention compared to usual care alone within a cluster randomized clinical trial among patients with type 2 diabetes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management (DM2) and prescribe medications for them
- •Participants
- •diagnosed with DM2
- •able to sign informed consent
- •fluent in either English or Spanish
- •HbA1c >8%
排除标准
- •Participants for whom an HbA1c target >8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences
研究组 & 干预措施
usual care
QBSafe intervention
干预措施: QBSafe (Behavioral)
结局指标
主要结局
HbA1c at Month 6
时间窗: Month 6
HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score.
Illness Intrusiveness Measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6
时间窗: Month 6
The change in illness intrusiveness measured by the validated Illness Intrusiveness Ratings Scale (IIRS). IIRS is comprised of 13 items that ask participants to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Overall score is calculated by summing the 13 items creating a value between 13 to 91, where higher scores indicate increased illness intrusiveness. Analysis will assess the 6 months response as the outcome adjusting for arm and the initial score. Subscales are scored 1-7 with higher scores indicating more disruption or intrusiveness.
次要结局
- Diabetes Distress Will be Measured Using the Diabetes Distress Scale (DDS-17) at Month 6(Month 6)
- Treatment Burden Will be Assessed Using the Treatment Burden Questionnaire (TBQ) at Month 6(Month 6)