Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058382) titled 'An Exploratory Study of the Personal Health Record Application for Self-Management of Hypertension Detected at Health Screening' on July 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Mie University
Condition:
Condition - Hypertension
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to introduce a lifestyle-related disease (hypertension) management application to subjects who have been found to have hypertension during health screenings, and to examine the effects of the application on the subjects' daily vital signs such as blood pressure, pulse rate, and weight, responses to a lifestyle-related self-check, and daily symptoms.The purpose of this study is to test whether a system that promotes awareness and behavioral change through the use of patient-reported outcome (PRO) and learning content is useful in the management of hypertension by comparing the traditional paper-based hypertension diary with a randomized trial.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group: self-management through a dedicated smartphone app
Interventions/Control_2 - Control group: Self-management using conventional blood pressure diary
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Age 18 years or older
2. Blood pressure measured at physical examination or in the examination room: 140-179/90-109 mmHg
3. SBP 130 mmHg or higher as measured by ABPM
4. Ownership of a smartphone that can be connected to the Internet environment and on which this application can be installed
5. The patient's free and voluntary written consent to participate in this study has been obtained after sufficient informed consent
Key exclusion criteria - 1. Those who do not have access to an Internet environment or do not have a smartphone capable of installing this application
2. Those who are unable to use a smartphone due to cognitive or physical decline or disability
3. Those who have withdrawn their consent to the installation of this application, the terms of use, and the consent form.
4. Those whose inclusion in the study is deemed inappropriate by the principal investigator or co-investigator
5. Those who are participating in other clinical studies that may affect the treatment of hypertension, or who are scheduled to participate in this study while participating in this study.
6. Patients with marked hypertension (equivalent to degree III hypertension) or those in need of emergency antihypertensive treatment.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066748
Disclaimer: Curated by HT Syndication.
