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

NCT07589881 | Completed

• 1 other identifier: 21/14
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Resistant Hypertension; Urinary Incontinence; Sexual Disfunction

Keywords

Resistant hypertension; Sexual dysfunction; Nurse-led intervention; Educational intervention; Ambulatory Blood Pressure Monitoring (ABPM); Medication Adherence; Adverse Effects of Antihypertensive Drugs; urinary health

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention

  The primary outcome of this study is the change in systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) before (baseline) and after the educational intervention (post-intervention). A reduction of at least 10 mmHg in systolic blood pressure is considered a significant clinical improvement. This outcome will be measured during both routine clinical visits and study-specific visits to assess the effectiveness of the nurse-led educational intervention in improving blood pressure control.

  Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program.

Secondary Outcomes (4)

• Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention

  Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program

• Medication Adherence Rate

  Adherence will be measured at baseline and post-intervention (at 6 months).

• sexual dysfunction

  At baseline and 6 months after the intervention.

• urinary incontinence

  At baseline and 6 months after the intervention.

Study Arms (2)

Educational intervention on the adverse effects of antihypertensive medication

EXPERIMENTAL

Patients in this group will receive a nurse-led educational program focused on the adverse effects of antihypertensive medications, particularly sexual dysfunction and urinary incontinence. The intervention aims to provide patients with tools and strategies to manage these side effects, improve their understanding of antihypertensive drugs, and enhance their adherence to prescribed treatments. 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.

Behavioral: Educational Intervention for Adverse Drug Effects

Standard Care

ACTIVE COMPARATOR

Patients in this group will receive standard care as prescribed by their nurse, without the added educational component focused on the adverse effects of antihypertensives. 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.

Other: routine care

Interventions

Educational Intervention for Adverse Drug Effects BEHAVIORAL

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.

Educational intervention on the adverse effects of antihypertensive medication

routine care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years.
• Diagnosis of resistant hypertension, defined as blood pressure not controlled despite the use of three or more antihypertensive medications.
• Uncontrolled blood pressure as measured by ambulatory blood pressure monitoring (ABPM).
• Resistant hypertension not secondary to other medical conditions (i.e., primary or essential hypertension).
• No use of antihypertensive medications other than the prescribed ones, and no intake of licorice (which can interfere with blood pressure).

You may not qualify if:

• Secondary causes of hypertension (e.g., endocrine disorders like hyperaldosteronism, pheochromocytoma, etc.).
• Severe cognitive impairment that would prevent the patient from understanding the intervention or providing informed consent.
• Uncontrolled psychiatric conditions that would interfere with participation (e.g., severe depression or psychosis).
• Hospitalization during the study period.
• Change of treatment regimen antihypertensive by a physician outside the study team (e.g., switching antihypertensive drugs or adding new medications without prior consultation with the study team).
• Participation in another clinical trial that might interfere with the study outcomes.
• Any other condition deemed inappropriate for study participation by the investigator.

Sponsors & Collaborators

• Consorci Sanitari Integral: lead

Study Sites (1)

Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral

Sant Joan Despí, Barcelona, E-08970, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence; Sexual Dysfunction, Physiological; Medication Adherence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: April 15, 2021
• Primary Completion: April 15, 2025
• Study Completion: December 31, 2025
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)