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

Primary Hypertension Clinical Trial

Official title:

National Defense Medical Center

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03470974
• Other study ID #: 2-104-05-148
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 13, 2018
• Start date: February 3, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: March 2018
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 222
• Est. completion date: July 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Primary Hypertension

Intervention

Behavioral:
• Self-titration strategy
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.

Locations

Country	Name	City	State
Taiwan	Tri-service General Hospital	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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