Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms

Yonsei University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Hypotension

Interventions

digital therapeuticsDEVICE

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.

digital therapeuticsDEVICE

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 99 Years

Medical Language ↔ Plain English

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).

Locations (1)

Yonsei university college of medicine

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: within the first 6weeks after intervention

Secondary Outcomes

Number of symptoms related to hypotension

Comparison of the frequency of symptoms suspected to be caused by hypotension before and after the intervention

Time frame: over 15weeks

Number of falling accident

To investigate whether regularly measuring blood pressure can help prevent falls.

Time frame: over 15weeks

Details for disease diagnosis and concomitant medications

To idenfity the correlation between hypotension and other causes and symptoms

Time frame: 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.

Time frame: at 15weeks

Data from ClinicalTrials.gov

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