Tokyo, March 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060827) titled 'Effectiveness of a digital peer supported app based program to prevent worsening of hypertension: a prospective observational study' on March 5.
Study Type:
Observational
Primary Sponsor:
Institute - Kitasato University
Condition:
Condition - Hypertension
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effectiveness of a digital peer supported app based program in preventing the progression of hypertension severity by facilitating online reciprocal engagement and encouragement.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - - Age 20 to 74 years.
- Having undergone a specific health checkup or comprehensive medical checkup, or having visited a medical institution within the past year, with available clinical laboratory results.
- Routine use of a smartphone.
Key exclusion criteria - -Diastolic blood pressure >= 100 mmHg or systolic blood pressure >= 160 mmHg (grade 2 hypertension or higher).
-Suspected or diagnosed secondary hypertension due to renovascular disease or endocrine/hormonal disorders.
-Diabetes mellitus.
-Deemed ineligible to participate by a physician.
-History of or current cardiovascular disease (e.g., angina, myocardial infarction, heart failure) or stroke (intracerebral hemorrhage or cerebral infarction).
-Chronic kidney disease or renal failure, or undergoing dialysis.
-Prohibited from exercise or restricted from participating in lifestyle modification programs by a physician.
-History of severe hypoglycemia that cannot be adequately self-managed.
-Pregnancy.
-Dyslipidemia (LDL-C >= 180 mg/dL or triglycerides >= 500 mg/dL). Note: Exclusion based on lipid criteria applies only to individuals who have not visited a medical institution.
Target Size - 350
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 11 Month 15 Day
Date of IRB - 2026 Year 01 Month 19 Day
Anticipated trial start date - 2026 Year 01 Month 20 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069603
Disclaimer: Curated by HT Syndication.