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NCT Number: NCT07589881

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    The change in diastolic blood pressure (DBP) from baseline to post-intervention will also be assessed using ambulatory blood pressure monitoring (ABPM) to evaluate the overall effect of the educational intervention on blood pressure control.

  2. Medication Adherence Rate

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

    Adherence to antihypertensive medications will be assessed using a 8-item Morisky test during the study visits. The goal is to assess whether the educational intervention improves medication adherence by addressing side effects, enhancing patient knowledge, and motivating consistent therapy adherence.

  3. sexual dysfunction

    Time frame: At baseline and 6 months after the intervention.

    Standardized questionnaires related to sexual health (for example, Sexual Health Inventory for Men (SHIM)

  4. urinary incontinence

    Time frame: At baseline and 6 months after the intervention.

    Standardized questionnaires will be applied to assess and urinary incontinence (for example, Incontinence Quality of Life (I-QOL)).

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Registry information

Official study title

Implementation of a Nurse-Led Educational Intervention on Adverse Effects of Antihypertensive Drugs in Patients With Resistant Hypertension: Focus on Sexual Dysfunction, Urinary Incontinence, and Qualitative Insights.

Acronym: HTAR-CSI

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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