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Participants who meet the inclusion/exclusion criteria in the Screening visit are randomly assigned 1:1 to the treatment group or the sham control group. The two-week period after Screening is the Run-in period, and the participant performs self-measured blood pressure monitoring, records data using the One.Dr application, and records symptoms and events related to orthostatic hypotension such as dizziness in the application. Only those who have completed the Run-in period will enter the Intervention period (for 6 weeks at 3-8 weeks), and according to each allocation group, non-pharmaceutical treatment education is provided for the treatment group and general health knowledge education is provided for the sham control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One.Dr Application | Experimental |
| |
| Sham Application | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital therapeutics (One.Dr Application) | Other | An application that provides educations and non-pharmaceutical treatment (participant customized content) for orthostatic hypotension via a smart device |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period | Orthostatic BP will be recorded during the Run-in period (2 wks) and the Intervetion period (6 wks). The orthostatic BP drops are expected to decrease in the treatment group than in the sham control group. | For 8 weeks after first use of digital therapeutics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Sun Kim, MD | Contact | 02-2228-8457 | kjs1218@yuhs.ac |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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| Digital therapeutics (Sham Application) | Other | An application that provides general health knowledge via a smart device |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |