Obesity
Conditions
Brief summary
This observational study is designed to determine the feasibility of recruitment from a digital research community of people using an anti-obesity medication for weight loss to understand willingness to consent to survey research and at home self-blood testing. This study will engage an active community of people using anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of participants to engage in a digital study, provide consent, and complete various study-related tasks, including a self-collected capillary blood sample for assay testing and health related surveys.
Interventions
DEVICETAP® Micro Select Device (Touch Activated Phlebotomy)
The TAP Micro Select device will be used in an investigational capacity by participants for self-collection of whole capillary blood.
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults 18 - 80 years of age. * Living in the United States. * Consented from the Inspire online platform patient community for COSMOS-DIGITAL. * Self-Reported current use of, and intention to continue for at least 30 days, one of the following medications for the indications of weight management/obesity: * Semaglutide (wegovy) * Tirzepatide (zepbound)
Exclusion criteria
* Currently receiving treatment in another investigational device or drug study, or participation in a current clinical trial. * Self-reported sensitivity/allergy to any of the components of the self-draw collection device including stainless steel or elements commonly found in stainless steel. * Self-reported fear of blood. * Self-reported circulatory conditions causing difficulty in drawing capillary blood. * Known history of bleeding diathesis or any coagulation disorder. * History of skin disorders, abnormal skin integrity or atypical skin health within the areas to be tested in the upper arm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Self-blood Draw Received by Central Laboratory | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management | Day 1 and Day 30 | — |
| Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity | Day 1 and Day 30 | — |
| Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire | Day 1 and Day 30 | — |
| Percentage of Consented Participants with Complete Self-reported Survey for Medical History | Day 1 | — |
| Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey | Day 30 | Participants will be asked about their satisfaction with using the device for the self-blood draw. |
| Percentage of Participants with Sufficient Volume of Blood Collected for Sampling | 30 days | — |
| Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary | 30 days | The daily diary will record answers about nausea symptoms. |
Countries
United States
Outcome results
None listed