Arterial hypertension
Conditions
Interventions
This is a two-arm, non-blind, randomized controlled clinical trial. Experimental group: 35 patients with uncontrolled hypertension will undergo home blood pressure monitoring for 5 days in one week pe
Sponsors
Departamento de Enfermagem da Universidade Federal do Ceará
Universidade Federal do Ceará
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with hypertension associated or not with Diabetes Mellitus; Coronary Artery Disease or Chronic Renal Failure; aged over 18 years; diagnosis time greater than 6 months; blood pressure greater than or equal to 140/90 mm Hg obtained during initial clinical consultation; be following the same antihypertensive medication treatment for at least 4 weeks; present mobility conditions to attend follow-up appointments at the health unit
Exclusion criteria
Exclusion criteria: Pregnant women; women actively seeking to become pregnant; those with physical and/or cognitive disabilities; those who have undergone surgical procedures, suffered accidents and/or amputations; those undergoing oncological treatment that makes it impossible to self-monitor blood pressure; inability to maintain the monitor at home represented by the participant's refusal to receive and keep the device; acute cardiovascular event in the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that individuals in the intervention group (IG), who undergo Home Blood Pressure Monitoring (HBPM), will present a significant reduction in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) values at the end of follow-up when compared with the control group (CG), which receives usual care only. The central hypothesis predicts a minimum reduction of 10 mmHg in SBP and 5 mmHg in DBP in the IG after the intervention period (three follow-up visits), with a statistically significant difference (p < 0.05) compared with the CG. This primary outcome was defined based on the study objectives and was used to calculate the sample size (n = 70).;A reduction of 16.71 mmHg in SBP (from 154.61 to 137.90 mmHg) and 12.47 mmHg in DBP (from 87.03 to 74.57 mmHg) was observed in the intervention group (IG), verified through the measurements obtained during the three follow-up visits. In the control group (CG), the reduction was 10.87 mmHg in SBP (from 152.67 to 141.80 mmHg) and 9.73 mmHg in DBP (from 88.67 to 78.94 mmHg) between the pre- and post-intervention periods. The difference between the groups was statistically significant (p < 0.001). | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in medication adherence among participants in the Intervention Group (IG), who are submitted to Home Blood Pressure Monitoring (HBPM), verified through the medication adherence questionnaire administered during the third follow-up visit. An increase in adherence scores is expected in the post-intervention assessment compared with the pre-intervention period and with the Control Group (CG).;A significant increase in the proportion of participants with high medication adherence was observed in the Intervention Group (IG) at the end of the study (53.85%) compared with the Control Group (CG) (33.33%), as verified through the medication adherence questionnaire applied during the third follow-up visit (p < 0.05). This result demonstrates the effectiveness of HBPM as an educational and motivational strategy to improve therapeutic adherence and blood pressure control. | — |
Countries
Brazil
Contacts
Public ContactAntonia da Silva
Universidade Federal do Ceará
Outcome results
None listed