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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational semaglutide treated cohort | This research focuses on adult subjects who have recently been prescribed semaglutide (Wegovy) for obesity or overweight. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who persisted on semaglutide treatment over the study period | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants discontinuing semaglutide due to unwanted side effects or other clinically significant reasons | Number and percentage of participants discontinuing semaglutide due to unwanted side effects or other clinically significant reasons measured as number and proportion of participants stopping semaglutide and the documented reason for discontinuation | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with Obesity or Overweight receiving semaglutide (Wegovy)
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| Name | Affiliation | Role |
|---|---|---|
| Susan Neese, MD | Amarillo Premier Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amarillo Premier Research (an Objective Health Partnership) | Amarillo | Texas | 37067 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Weight loss from baseline to end of study | Weight loss from baseline to end of study comprising weight loss magnitude and rate, assessed by absolute and percentage change in body weight | 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 | At the end of the study, participants will complete a brief e-questionnaire to capture their experience of the WeDosify-supported treatment journey. The questionnaire will use 5-point Likert scale and free text questions to assess:
| 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) | The Healthcare Professional (HCP) will complete a custom e-questionnaire at the end of the study to capture their overall experience of using the WeDosify tool. This e-questionnaire will use 5-point Likert scale and free text questions to assess:
| 3 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |