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An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI)

NCT07589881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-05-15

No results posted yet for this study

Summary

This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary incontinence-in patients with resistant hypertension. The intervention aims to improve treatment adherence and blood pressure control. The primary outcome is a reduction of ≥10 mmHg in systolic blood pressure, measured by ambulatory blood pressure monitoring (ABPM) before and after the intervention during routine and study-specific visits. The study targets adult patients on three or more antihypertensive medications who experience or are at risk of drug-related side effects. This educational approach is expected to enhance patient understanding, reduce treatment discontinuation, and improve clinical outcomes.

Conditions

Interventions

BEHAVIORAL

Educational Intervention for Adverse Drug Effects

Patients will receive from 6 to 9 educational sessions, each lasting approximately 30-45 minutes. The sessions will occur over a period of 6 months, with follow-up as necessary during study visits.The intervention will include: * One-on-one sessions with trained nurse. * Education about common side effects of antihypertensives. * Techniques to reduce the impact of side effects. * Discussions around maintaining adherence to therapy. * Strategies for addressing issues related to sexual health and urinary continence.

OTHER

routine care

Patients will receive standard care as prescribed by their nurse. This group will continue their usual treatment regimen for resistant hypertension, which may include medication adjustments and general counselling by nurse as part of their routine visits.

Sponsors & Collaborators

  • Consorci Sanitari Integral

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2025-04-15
Completion
2025-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07589881 on ClinicalTrials.gov