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

Not Applicable

• Conditions: Primary Hypertension
• Interventions: Behavioral: Self-titration strategy

• Registration Number: NCT03470974
• Lead Sponsor: Tri-Service General Hospital

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.

Study Timeline

• Study Start: 2017-02-03
• Status Verified: 2018-03
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-13
• Last Update Submitted: 2018-03-13
• Study First Posted: 2018-03-20
• Last Update Posted: 2018-03-20
• Primary Completion: 2018-04-30
• Study Completion: 2018-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Self-titration strategy	The intervention group receives self-titration strategy training and lifestyle education.

Primary Outcome Measures

Name	Time	Method
evaluate the effects of self-titration strategy on the improvement of home blood pressure	up to 3 months	Patients evaluated their home blood pressure by corrected sphygmomanometer.

Trial Locations

Locations (1)

Tri-service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan