Primary HypertensionNCT03470974
The Effect of Self-Titration and Predictors for Blood Pressure Control in Patients With Hypertension
A study testing Self-titration strategy in people with Primary Hypertension, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Self-titration strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Feb 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Defense Medical Center
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.
Read the 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.
- Conditions
- Primary Hypertension
- Being tested
- Self-titration strategy
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-titration strategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group receives self-titration strategy training and lifestyle education. Receives: Behavioral: Self-titration strategy |
| Control Group | No intervention | The control group receives usual care and lifestyle education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the effects of self-titration strategy on the improvement of home blood pressure
Patients evaluated their home blood pressure by corrected sphygmomanometer.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start3 Feb 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fung-Wei Chang, Tri-Service General Hospital (TSGH)
- Investigators
- Chi-Wen Kao, Ph.D., Study director, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470974
- Sponsor's protocol ID
- 2-104-05-148
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31804186
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Defense Medical Center
- ClinicalTrials.gov ID
- NCT03470974
- Acronym / sponsor ID
- 2-104-05-148
- Conditions
- Primary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Self-titration strategyThe intervention group receives self-titration strategy training and lifestyle education. |
| Control Group | No intervention | –The control group receives usual care and lifestyle education. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-titration strategyThe 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. | Behavioural | Intervention Group |
Primary outcome
evaluate the effects of self-titration strategy on the improvement of home blood pressure
Time frame: up to 3 months
Patients evaluated their home blood pressure by corrected sphygmomanometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 31804186Kao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Wen Kao, Ph.D. study director
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-titration strategy in people with Primary Hypertension, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the effects of self-titration strategy on the improvement of home blood pressure (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.