PREDHICT: Precision Recruitment and Engagement of Diabetics and Hypertensives in Clinical Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in clinical trials participation Change in User Adherence
研究概览
简要总结
For the sub-study, this digital navigation tool will both inform/educate, engage, support, and navigate participants and providers through the process of clinical trial participation via personalization (data profiling, adaptive and customized messaging, and tailored digital navigation) in a sample of 100 participants with diabetes and hypertension.
详细描述
To identify provider- and system-level facilitators (solutions) of clinical trial participation that can be in corporated in the digital navigation tool. We will pay special emphasis on the behavior research volunteerism and altruism and individuals who are at risk for cardio metabolic conditions. To develop solutions that will address patient-, provider and system-level barriers preventing clinical trial participation Objective 2: To test the adherence, feasibility, and efficacy of a research volunteerism and altruism component of a health and wellness web app. that provides personalized newsfeeds and curriculum about research and health-related volunteer and altruistic activities versus traditional patient navigation procedures and resources in clinical trial awareness.'awareness/knowledge, attitudes, willingness to participate in clinical trial, self-efficacy, and share knowledge about clinical trial opportunities to social network. To determine which elements of the digital tool and mobil app are associated with increased awareness/knowledge, intent to participate, and contagion
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NYU and/or Bellevue patient
- •Diagnosed with HTN and pre-diabetes/diabetes
- •Must be English speakers
- •Ownership of a smart phone and are willing to use it to download app built in TrialX which will be free for participants
- •Must be ambulatory
排除标准
- •are unable or unwilling to provide informed consent;
- •are unable to participate meaningfully in an intervention that involves self-- monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
- •are institutionalized (e.g., in a nursing home or personal care facility, or those who - are incarcerated and have limited control over self-management)
- •have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)
结局指标
主要结局
Change in clinical trials participation Change in User Adherence
时间窗: Baseline Visit, 4 week follow up visit, 6 month follow up visit
Will show that one-size-fits-all versus personalization leads to greater adherence. Adherence will be based on whether the subject met the daily and weekly behavior recommendations.
Change in glucose level Change in blood pressure
时间窗: Baseline Visit, 4 week follow up visit, 6 month follow up visit
The amount of sugar levels will be determined the Harris-Benedict Calculator, which consists of height, weight, weight age and activity levels
Change in physical activity
时间窗: Baseline Visit, 4 week follow up visit, 6 month follow up visit
FitBit tracking will measure increase in physical activity adherence.
Change in physical activity by self-report
时间窗: Baseline Visit, 4 week follow up visit, 6 month follow up visit
Increase in physical activity will be measured by self-report diaries collected by study staff through health and wellness app platforms.
Change in body mass index Change in blood pressure
时间窗: Baseline Visit, 4 week follow up visit, 6 month follow up visit
Change in body mass index will be determined by the self reported information the vb=vodt
次要结局
未报告次要终点