Newly diagnosed hypertension encoded I10 (hypertension i.e. essential or primary arterial hypertension i.e. high blood pressure) or I11.9 (hypertensive heart disease with no (congestive) heart failure). Circulatory System Essential (primary) hypertension
Conditions
Interventions
At the early stages of medication treatment of hypertension, the physician shall be provided with the information regarding individual genetic risk of complications together with the standardised feed
Sponsors
Archimedes Foundation (Estonia)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male, 18 to 65 years of age, who is subject to one of the followings: 1. Newly diagnosed hypertension* encoded** I10 [hypertension i.e. essential or primary arterial hypertension i.e. high blood pressure) or I11.9 (hypertensive heart disease with no (congestive) heart failure] or previously diagnosed hypertension encoded I10 or I11.9, with no medication treatment receive or previously diagnosed hypertension encoded I10 or I11.9 with assigned medication treatment that has been discontinued at least two months ago * mean arterial blood pressure of three measurements: systolic over 140; and/or diastolic over 90 mmHg ** here and hereinafter the diagnosis codes are presented according to the 10th revision of the International Classification of Diseases The patient shall (re)start the medication treatment of hypertension according to the physician?s assessment 2. ECG findings: sinus rhythm, without signs of having suffered from myocardial infraction and/or of acute ischemia 3. Gives an informed consent to participate in the study 4. The subject is prepared to find out his genetic risks
Exclusion criteria
Exclusion criteria: Physical or psychological comorbidities/conditions or their treatment which, according to the attending physician's assessment, may prevent or significantly affect: 1. Giving the informed consent 2. Participating in the study 3. The mean arterial blood pressure of three measurements during Visit 1: systolic over 180; and/or diastolic over 110 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaires used for hypertension treatment adherence assessment include : 1. Medication adherence (MMAS-8 and BMQ) is measured at 1.5 months, 3.5 months, 6 months and 12 months. MMAS-8 medication adherence questionnaire is comprised of 8 questions, the first seven of which can be answered with yes/no (yes=1 and no=0). The answers for the last question will give correspondingly 4, 3, 2, 1, or 0 points. The points are added and the medication adherence of the subject is evaluated according to the amount of points (8=good medication adherence, 6-7 average medication adherence, and less than 6 poor medication adherence). The score of medication adherence is calculated in the Estonian Genome Center of the University of Tartu (EGCUT). For evaluating the BMQ questionnaire, there is a special table (presented by the author Bonni Svarstad), where treatment regimen adherence, occurrence of medication-related problems, and medication adherence related to forgetting and the availability of the medication are separately evaluated. The medication adherence rates are calculated by adding together the answers (yes=1 and no=0). The score of medication adherence is calculated in the EGCUT. 2. Registering medications prescribed and purchased at 1.5 months, 3.5 months, 6 months and 12 months. Registering medications prescribed and purchased according to the data in the Digital Prescription Center's digital prescription database, the data collector shall write them down into the corresponding form in the study folder. 3. Measuring and recording subjects' blood pressure and weight at baseline, 1.5 months, 3.5 months, 6 months and 12 months. The data collector shall measure the subject's blood pressure, body length, weight, waist and hip measurements (to evaluate the effectiveness of non-medication treatment) in a conventional way with devices that are in his/her possession, it is preferable to measure the subject with t | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measuring of blood pressure at baseline, 1.5 months, 3.5 months, 6 months and 12 months. Treatment effectiveness of hypertension: drop in systolic and diastolic blood pressure. 2. Smoking history recorded at baseline, 3.5 months, 6 months. Non-medication treatment adherence of hypertension (lifestyle recommendations) in subgroups (smokers, overweight individuals). | — |
Countries
Estonia
Outcome results
None listed