Hypotension
Conditions
Brief summary
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.
Interventions
DEVICEdigital therapeutics
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
Participant and Sub-investigator
Eligibility
Sex/Gender
ALL
Age
19 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 19 and older with symptoms suspected to be related to dizziness due to hypotension within the past year. 2. Individuals who are able to walk and can participate in the study using a smartphone, or for whom cooperation from a guardian is available.
Exclusion criteria
1. Individuals diagnosed with causes of dizziness other than hypotension, such as benign paroxysmal positional vertigo or stroke, within the past year. 2. Severe anemia (history of Hb \< 8.0 g/dL within the last 3 months). 3. Individuals unable to use a smartphone (Android phone) or smartwatch. 4. Individuals with a life expectancy of less than 1 year due to diseases such as malignant tumors. 5. Individuals diagnosed with severe heart valve disease or severe heart failure with LVEF \< 35% (based on the most recent examination). 6. Recent rapid and unintended weight loss (5% or more, or 5 kg or more, within the last 6 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of hypotension symptom events | within the first 6weeks after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of symptoms related to hypotension | over 15weeks | Comparison of the frequency of symptoms suspected to be caused by hypotension before and after the intervention |
| Number of falling accident | over 15weeks | To investigate whether regularly measuring blood pressure can help prevent falls. |
| Details for disease diagnosis and concomitant medications | over 15weeks | To idenfity the correlation between hypotension and other causes and symptoms |
| The frequency of use of digital therapeutics | at 15weeks | 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. |
Countries
South Korea
Outcome results
None listed