NCT03470974

Brief Summary

This study aims to investigate the relationship among self-efficacy, anxiety, depressive symptoms, quality of life, lifestyle, heart rate variability and blood pressure control; and to examine the effects of self-titration strategy on self-efficacy, anxiety, depressive symptoms,heart rate variability, sodium excretion, lifestyle modification,quality of life, and blood pressure control in patients with hypertension.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 3, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

March 13, 2018

Last Update Submit

March 13, 2018

Conditions

Primary Hypertension

Outcome Measures

Primary Outcomes (1)

  • evaluate the effects of self-titration strategy on the improvement of home blood pressure

    Patients evaluated their home blood pressure by corrected sphygmomanometer.

    up to 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group receives self-titration strategy training and lifestyle education.

Behavioral: Self-titration strategy

Control Group

NO INTERVENTION

The control group receives usual care and lifestyle education.

Interventions

Self-titration strategyBEHAVIORAL

The self-titration strategy allows patients or medical professionals to adjust their medicine (additional, maintain, or decrease dose) depending on a bespoke plan. The bespoke plan for hypertensive patients involves setting target blood pressure, self-monitoring blood pressure, recording blood pressure readings and constructing a medication titration schedule. Each medication titration step is conducted based on the average home BP measurement readings.

Intervention Group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 20 years old.
  • diagnosed with primary hypertension.
  • no addiction to drugs or alcohol.
  • not using anti-depression therapy.
  • able to read and understand Chinese or Taiwanese.
  • willing to participate in this study.

You may not qualify if:

  • stroke.
  • arrhythmia.
  • major psychiatric disorders
  • thyroid disease.
  • had received a heart transplant, a permanent pacemaker or an implantable cardioverter defibrillator, diagnosed with (6) cancer, (7) heart failure, or (8) acute myocardial infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-service General Hospital

Taipei, Neihu District, 11490, Taiwan

Location

Related Publications (1)

  • Kao CW, Chen TY, Cheng SM, Lin WS, Chang YC. A Web-Based Self-Titration Program to Control Blood Pressure in Patients With Primary Hypertension: Randomized Controlled Trial. J Med Internet Res. 2019 Dec 5;21(12):e15836. doi: 10.2196/15836.

    PMID: 31804186DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Chi-Wen Kao, Ph.D.

    Tri-Service General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 20, 2018

Study Start

February 3, 2017

Primary Completion

April 30, 2018

Study Completion

July 31, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)