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The Effect of Self-Titration and Predictors for Blood Pressure Control in Patients With Hypertension

Primary Purpose

Primary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self-titration strategy
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Primary Hypertension

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ≥ 20 years old.
  2. diagnosed with primary hypertension.
  3. no addiction to drugs or alcohol.
  4. not using anti-depression therapy.
  5. able to read and understand Chinese or Taiwanese.
  6. willing to participate in this study.

Exclusion Criteria:

  1. stroke.
  2. arrhythmia.
  3. major psychiatric disorders
  4. thyroid disease.
  5. 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.

Sites / Locations

  • Tri-service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

The control group receives usual care and lifestyle education.

Outcomes

Primary Outcome Measures

evaluate the effects of self-titration strategy on the improvement of home blood pressure
Patients evaluated their home blood pressure by corrected sphygmomanometer.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2018
Last Updated
March 13, 2018
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03470974
Brief Title
The Effect of Self-Titration and Predictors for Blood Pressure Control in Patients With Hypertension
Official Title
National Defense Medical Center
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
July 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Background: Hypertension is the major cause of mortality for the cardiac, vascular and renal disease. The effective control of elevated blood pressure may reduce the damages of several target organs. World Health Organization points out "Innovation and Empowerment for health". The self-titration strategy may empower patients to self-control their diseases, share decision-making and increase their ability to self-management their situations and improve their home blood pressure. Methods: This experimental study included 222 hypertensive patients from outpatient services of cardiology departments of a medical center in northern Taiwan. We randomly divided the 72 patients into the experimental group (n=111) and control group (n=111). The experimental group received self-titration strategy training and lifestyle modification education; the control group received usual care and lifestyle modification education. Data were collected for self-efficacy, anxiety symptoms, depressive symptoms, lifestyle and health-related quality of life using self-report questionnaires. Heart rate variability was measured with CheckMyHeart device (DailyCare BioMedical, Chungli, Taiwan). Patients evaluated their home blood pressure by corrected sphygmomanometer. We used the generalized estimating equation to evaluate the effects of the intervention. Purpose: Primary outcome to evaluate the effects of self-titration strategy on the improvement of home blood pressure in patients with hypertension. Secondary outcomes to evaluate the effects of self-titration strategy on the improvement of self-efficacy, anxiety, depressive symptoms and lifestyle quality of life in patients with hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group receives self-titration strategy training and lifestyle education.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group receives usual care and lifestyle education.
Intervention Type
Behavioral
Intervention Name(s)
Self-titration strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
evaluate the effects of self-titration strategy on the improvement of home blood pressure
Description
Patients evaluated their home blood pressure by corrected sphygmomanometer.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Wen Kao, Ph.D.
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tri-service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
11490
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31804186
Citation
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.
Results Reference
derived

Learn more about this trial

The Effect of Self-Titration and Predictors for Blood Pressure Control in Patients With Hypertension

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