WeDosify Real-World Evidence: Evaluating a Clinical Decision Support and Patient Engagement Tool for Personalized Semaglutide Dosing in Adults With Overweight or Obesity in the United States
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of participants who persisted on semaglutide treatment over the study period
研究概览
简要总结
This research study is studying WeDosify, an interactive web-based Clinical Decision Support tool that assists healthcare professionals in managing adults with excess weight or obesity using a Glucagon-like peptide-1 (GLP-1) drug treatment such as semaglutide.
详细描述
Researchers at Amarillo Premier Research, working with Closed Loop Medicine Ltd (CLM), want to improve how excess weight and obesity are managed. There is a need for tools that support more consistent, data-informed and personalized treatment decisions in weight management. This research focuses on subjects who have recently been prescribed semaglutide (Wegovy). Semaglutide is a widely used medicine that helps patients to lose excess weight and belongs to a group of medicines called Glucagon-like peptide 1s (GLP-1s).
Only subjects who are receiving semaglutide treatment as part of their routine weight management will be invited by the study doctor to join this research study. Once consented, the study doctor will have access to a product called WeDosify, an interactive web-based Clinical Decision Support tool that assists healthcare professionals in managing adults with excess weight or obesity using GLP-1 treatment.
Participation in this study will last approximately 3 months and will include approximately 4 consultations, either study visits to the research center or remote consultations
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants must be 18 years or older.
- •Participants must have a diagnosis of either obesity or overweight.
- •Participants must have initiated first-time semaglutide treatment within the past 4-12 weeks for the management of overweight or obesity, in line with United States Prescribing Information (USPI) and the clinical judgment of the responsible Healthcare Professional (HCP).
- •Participants must have access to and be able to use suitable weighing scales to record their weight before or during consultations.
- •Participants must provide written informed consent to participate in this study, including agreeing to adhere to the associated procedures.
排除标准
- •Participants with conditions that the Healthcare Professional (HCP) deems would prevent effective use of weighing scales and accurate self-monitoring or reporting of body weight.
- •Failure to satisfy the responsible Healthcare Professional (HCP) of fitness to participate for any other reason.
结局指标
主要结局
Percentage of participants who persisted on semaglutide treatment over the study period
时间窗: 3 months
The primary outcome is treatment persistence during the 3-month observation period, defined as the proportion of participants who remain on semaglutide treatment without discontinuation. Discontinuation will be defined as either a formal cessation of medication or the absence of a prescription renewal within the expected timeframe
次要结局
- Number and percentage of participants discontinuing semaglutide due to unwanted side effects or other clinically significant reasons(3 months)
- Weight loss from baseline to end of study(3 months)
- Patients' experience of WeDosify and perceived impact of treatment using custom Patient-Reported Experience Measure (PREM) and Patient-Reported Outcome Measure (PROM) questionnaires at end of study(3 months)
- Healthcare Professional (HCP) user experience and perceived utility assessed by custom questionnaire at end of study (to include utilization and ease of use)(3 months)