Arterial hypertension MedDRA version: 19.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: DOXAZOSIN
Other descriptive name: DOXAZOSIN
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 2-
Pharmaceuti
Sponsors
Instituto de Investigación Sanitaria INCLIVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 40 years or older - have a diagnosis of hypertension of any origin - have a TAS> 145 or TAD> 90 mm Hg on the baseline examination - voluntarily agree to participate in the study and sign the corresponding informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 158 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: - inability to self-care of their blood pressure, understanding, performing and / or self-adjusting of medication by the patient, including dementia or significant cognitive impairment at the discretion of the investigator performing the recruitment - history of orthostatic hypotension (fall> 20 mm Hg in systolic arterial tension after the orthostatic position) - have a blood pressure> 200 or diastolic blood pressure> 100 mm Hg at baseline - being on treatment with more than 4 antihypertensive drugs - be included in another high blood pressure study or in a clinical trial - presence of tremor or neurological disease that makes it difficult to perform AMPA - presence of arrhythmia - presence of terminal illness - chronic incapacitation to leave your home - have had an acute cardiovascular event in the last 3 months - arterial hypertension managed directly by specialist physicians outside the Primary Care setting - spouse selected for the study - non-resident or transient patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of an intervention based on self-monitoring and self-adjustment of medication in poorly controlled hypertensive patients.;Secondary Objective: - Evaluate its impact on adherence to treatments, lifestyles, quality of life, occurrence of adverse events, use of health services, and costs of care. - Estimate its efficiency (cost-effectiveness). - Evaluate the visions and experiences of patients, caregivers and health professionals about self-management, self-monitoring and self-adjustment of antihypertensive medication;Primary end point(s): Difference in mean systolic blood pressure, in mmHg, at 12 months follow-up between the intervention and control groups, determined in consultation with a validated automatic electronic sphygmomanometer;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean systolic blood pressure, in mmHg, at 6 and 24 months of follow-up. - Mean diastolic blood pressure, in mmHg, at 6, 12, and 24 months of follow-up. It will be done in the same way and at the same time as the systolic blood pressure - Percentage of patients with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg at 6, 12 and 24 months of follow-up. - Scoring in the EuroQoL-5D at 6, 12 and 24 months of follow-up. - Proportion of days covered by PDC, calculated by dividing the number of days of medication dispensed by the number of days of the observed follow-up period. Patients with PDC equal to or greater than 80% will be considered adherent. In the case of polymerization, patients with PDC=80% in all drugs will be considered adherent. - Persistence, defined as time of continuous use of the corresponding drug from the beginning of the follow-up until its discontinuation (when the patient does not pick up the medication after a 60-day grace period, after the period with medication available from the Dispensation). - Therapeutic inertia (IT) defined as the quotient between the number of patients who had not been modified by the pharmacological treatment divided by the number of patients with the SST and / or blood pressure measurements Sistólicatomadas in consultation at 6, 12, and 24 months of follow-up higher than the target values ??according to the recommendations of the European Society of Hypertension and European Society of Cardiology.;Timepoint(s) of evaluation of this end point: 6, 12 y 24 months | — |
Countries
Spain
Contacts
Public ContactScientific Subdirector
Instituto de Investigación Sanitaria INCLIVA
Outcome results
None listed