Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial is an exploratory study aimed at assessing the efficacy and safety of a digital therapeutic for managing symptoms of hypotension, with the goal of providing evidence for the design of future confirmatory clinical research.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early intervention group (EIG) | Experimental | the trial group that begins treatment in the 3-week of the total 15-week study period |
|
| Late intervention group (LIG) | Experimental | the comparator group that begins treament in the 9-week of the total 15-week study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| digital therapeutics | Device | Early intervention group will undergo app usage training, disease education, blood pressure measurements, orthostatic blood pressure measurements, and postprandial blood pressure measurements up to the third week of participation. From the fourth week onward, for a duration of 12 weeks, non-pharmacological treatment education will be provided through a digital therapeutic, and blood pressure will be measured according to a specified schedule. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of hypotension symptom events | The effectiveness of symptom improvement for hypotension was evaluated in the trial and control groups based on the frequency of hypotension symptoms over a 6-week period. | within the first 6weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of symptoms related to hypotension | Comparison of the frequency of symptoms suspected to be caused by hypotension before and after the intervention | over 15weeks |
| Number of falling accident |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei university college of medicine | Seoul | 03722 | South Korea |
Not provided
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Participant and Sub-investigator
|
| digital therapeutics | Device | Late intervention group will undergo app usage training, disease education, blood pressure measurements, orthostatic blood pressure measurements, and postprandial blood pressure measurements up to the ninth week of participation. From the tenth week onward, for a duration of 6 weeks, non-pharmacological treatment education will be provided through a digital therapeutic, and blood pressure will be measured according to a specified schedule. |
|
To investigate whether regularly measuring blood pressure can help prevent falls.
| over 15weeks |
| Details for disease diagnosis and concomitant medications | To idenfity the correlation between hypotension and other causes and symptoms | over 15weeks |
| The frequency of use of digital therapeutics | To identify how many times participants use digital therapeutics to measure blood pressure. Display the frequency of data input through digital therapeutics as the mean or median. | at 15weeks |