- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513430
Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control
August 23, 2022 updated by: Asst. Prof. Zeynep Gunes Ozunal, M.D., Maltepe University
Study is an observational study among hypertensive patients
Study Overview
Status
Completed
Conditions
Detailed Description
Objective: To investigate drug adherence and lifestyle behaviors affecting the blood pressure (BP) control among hypertensive patients that have uncontrolled and controlled BP.
Study Type
Observational
Enrollment (Actual)
176
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 74 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
hypertensive patients
Description
Patient inclusion criteria were as follows:
- aged between 38 and 74 years,
- hypertension diagnosis history of at least 6 months
- use of at least one antihypertensive medication.
Exclusion Criteria:
-not willing to join the clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
controlled hypertension
Controlled hypertension was defined as systolic blood pressure (SBP) ≤139 mmHg and/or diastolic blood pressure (DBP)≤89 mmHg for non-diabetic patients, and as SBP ≤139 mmHg and/or DBP ≤84 mmHg for diabetic patients, based on the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) guidelines.
observational study
|
uncontrolled hypertensive patients.
Individuals who had blood pressure levels above these values were defined as uncontrolled hypertensive patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
health related quality of life.
Time Frame: at the time of the beginning of the study
|
EQ-5D-3L turkish validation test
|
at the time of the beginning of the study
|
Age
Time Frame: at the time of the beginning of the study
|
years
|
at the time of the beginning of the study
|
Gender
Time Frame: at the time of the beginning of the study
|
Female/Male
|
at the time of the beginning of the study
|
BMI
Time Frame: at the time of the beginning of the study
|
(kg/m2)
|
at the time of the beginning of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complementary and alternative medicine use
Time Frame: at the time of the beginning of the study
|
subjective reports from patients (yes/no)
|
at the time of the beginning of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
- Özünal, Z. G., Tahirbegolli, I. A., Baykal, M., Belen, A. T. E. Ş., Tahirbegolli, B., KILIÇ, Y., ... & Üresin, A. Y. (2019). The drug adherence and lifestyle factors that contribute to blood pressure control among hypertensive patients.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2014
Primary Completion (Actual)
November 30, 2014
Study Completion (Actual)
November 30, 2014
Study Registration Dates
First Submitted
August 24, 2017
First Submitted That Met QC Criteria
August 23, 2022
First Posted (Actual)
August 24, 2022
Study Record Updates
Last Update Posted (Actual)
August 24, 2022
Last Update Submitted That Met QC Criteria
August 23, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000001 (Kaiser Permanente Southern California IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension,Essential
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Addpharma Inc.Completed
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
BayerCompletedHypertension, EssentialGermany
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Addpharma Inc.Not yet recruitingHypertension,Essential
-
Instituto de Cardiologia do Rio Grande do SulRecruitingHypertension | Hypertension,EssentialBrazil
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLCNot yet recruitingHypertension | Hypertension,Essential