Women in Control: A Virtual World Study of Diabetes Self-Management. Translational Research to Improve Diabetes and Obesity Outcomes (R01)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Change in physical activity level
研究概览
简要总结
This study evaluates the comparative effectiveness of a diabetes self management (DSM) group medical visit in the virtual world (Second life) verses a face-to-face format, aimed to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled diabetes mellitus.
详细描述
The prevalence of diabetes mellitus (DM) in the US is disproportionately high among minority women. In order to participate as partners in healthcare, DM patients need self-management education and support. Diabetes self-management (DSM) support is effective in helping DM patients make good choices and achieve clinical goals but is difficult to deliver in medical practice settings. Virtual reality technology can assist DM patients and their clinical teams with DSM support by providing effective educational tools in an engaging, learner-centered context that fosters self-efficacy and skill proficiency. Our prior work demonstrated that virtual worlds, like Second Life (SL), are suitable for supporting DSM education for patients. SL, an Internet-based virtual world, is an example of an immersive, three-dimensional environment which supports social networking and interaction with information.
The investigators now aim to enhance the existing diabetes curriculum using a medical group visit design to study whether the Women in Control virtual world group medical visit leads to similarly effective health and educational outcomes compared to face-to-face group medical visits. The investigators aims are to conduct a randomized, controlled trial of the comparative effectiveness of a virtual world DSM group medical visit format vs. a face-to-face DSM group visit format to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled DM at six month follow up, and to conduct a qualitative, ethnographic study of participant engagement with the virtual world platform during the virtual world group sessions, between group sessions, and following completion of the eight-week curriculum to characterize learners' self-directed interactions with the technology platform and assess the correlation of these interactions with DSM behaviors and diabetes control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus (documented in the medical chart)
- •Last recorded HbA1c >8.0
- •Currently treated with diet, oral hypoglycemic agents or insulin
- •Black/African American or Hispanic/Latina origin
- •Has telephone access
- •Able to understand and participate in study protocol
- •Functionally capable of meeting the activity goals
- •Understand and give informed consent
- •Physician approval to participate in study
- •Can communicate in English or Spanish
排除标准
- •History of diabetic ketoacidosis
- •Currently or planning pregnancy
- •Unable or unwilling to provide informed consent
- •Plans to leave area within 6 month study period that would interfere with ability to attend 8 weekly sessions and/or 6 month follow up
- •Required intermittent glucocorticoid therapy within past 3 months.
- •Experienced acute coronary event (myocardial infarction or unsable angina) within previous 6 months
- •Medical condition that precludes adherence to study dietary recommendations (i.e. Crohn's, ulcerative colitis, etc)
- •Medical or serious psychiatric illness (dementia, suicidal within last 5 months, psychiatric hospitalization). Those with diagnosis of depression or who take antidepressents are eligible.
结局指标
主要结局
Change in physical activity level
时间窗: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Participants will wear an activity monitor for a week at each collection point. Results measured in METs/hr.
Change in disease control (HbA1c)
时间窗: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Change in HbA1c from BMC laboratory blood testing results
次要结局
- Health-Related Quality of Life(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Functional Status(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Improvement in cholesterol, hypertension and body weight(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Patient Activation(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Social Support(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Health Service Utilization(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Medication Adherence(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Depression(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Dietary Habits(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)
- Stress(Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up)