NCT05712070

Brief Summary

This study is a randomized, open-label clinical trial to validate the efficacy and safety of smartphone app-guided life style modification for the management of hypertension and hyperlipidemia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

March 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

January 26, 2023

Last Update Submit

January 26, 2023

Conditions

HypertensionHyperlipidemiasChronic DiseaseLifestyle Risk Reduction

Keywords

smart healthcare

Outcome Measures

Primary Outcomes (2)

  • Mean change in 24-hour ambulatory systolic BP from baseline to 12 weeks

    in patients with hypertension \[Category 1 \& 3\]

    at 12-week follow-up

  • Mean change in serum LDL-cholesterol level from baseline to 12 weeks

    in patients with hyperlipidemia \[Category 2 \& 3\]

    at 12-week follow-up

Secondary Outcomes (15)

  • Mean change in 24-hour ambulatory diastolic BP from baseline to 12 weeks

    at 12-week follow-up

  • Mean change in daytime systolic BP from baseline to 12 weeks

    at 12-week follow-up

  • Mean change in daytime diastolic BP from baseline to 12 weeks

    at 12-week follow-up

  • Mean change in nighttime systolic BP from baseline to 12 weeks

    at 12-week follow-up

  • Mean change in nighttime diastolic BP from baseline to 12 weeks

    at 12-week follow-up

  • +10 more secondary outcomes

Study Arms (2)

smart group

EXPERIMENTAL

Smartphone App-based healthcare

Behavioral: App-guided lifestyle modification

control group

ACTIVE COMPARATOR

a book-based self-education

Behavioral: A book-based self-education of lifestyle modification

Interventions

App-guided lifestyle modificationBEHAVIORAL

Smart watch and smartphone application-based life style modification for 12 weeks

smart group
A book-based self-education of lifestyle modificationBEHAVIORAL

A take-home book-based self-education for lifestyle modification

control group

Eligibility Criteria

Age20 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • health insurance subscribers who are aged 20-54 years
  • hour ambulatory systolic BP 130-159 mmHg or serum LDL ≥130 mg/dl
  • Android smartphone users who can use ICT-based helathcare application
  • no use of anti-hypertensive or lipid-lowering drugs for ≥3 months prior to screening
  • subjects who are considered appropriate to be managed with lifestyle modification for 12 weeks
  • Subject who understands the purpose of the study and signs with informed consent form

You may not qualify if:

  • hour ambulatory systolic or diastolic BP \>160 mmHg or \> 110 mmHg
  • underlying cardiovascular disease (ischemic heart disease, heart failure, aortic disease, valvular heart disease, arrhythmia, cardiomyopathy, etc.)
  • underlying cerebrovascular disease (stroke, cerebral infarction or hemorrhage, cerebral aneurysm, etc.)
  • chronic renal disease
  • peripheral vascular disease
  • pregnancy
  • secondary hypertension
  • atrial fibrillation or flutter
  • severe bradyarrhythmia
  • difficulty in BP measurement by smart watch
  • difference in systolic BP measurements from both arms \> 10mmHg
  • life expectancy \< 2 years
  • medical conditions that would limit adherence to participation (as confirmed by physicians)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionHyperlipidemiasChronic DiseaseRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Soo-Jin Kang, M.D.

CONTACT

+82230103157sjkang3157@gmail.com

Tae-Oh Kim, M.D.

CONTACT

+82230103150allldie@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., PhD.

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 3, 2023

Study Start

March 2, 2023

Primary Completion

December 30, 2023

Study Completion

February 28, 2024

Last Updated

February 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share