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

11 maja 2026 zaktualizowane przez: Consorci Sanitari Integral

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.

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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

46

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Barcelona
      • Sant Joan Despí, Barcelona, Hiszpania, E-08970
        • Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Educational intervention on the adverse effects of antihypertensive medication

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.

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.
Aktywny komparator: Standard Care
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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
Ramy czasowe: 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.
Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention
Ramy czasowe: 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.
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
Ramy czasowe: 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.
Adherence will be measured at baseline and post-intervention (at 6 months).
sexual dysfunction
Ramy czasowe: At baseline and 6 months after the intervention.
Standardized questionnaires related to sexual health (for example, Sexual Health Inventory for Men (SHIM)
At baseline and 6 months after the intervention.
urinary incontinence
Ramy czasowe: 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)).
At baseline and 6 months after the intervention.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 kwietnia 2021

Zakończenie podstawowe (Rzeczywisty)

15 kwietnia 2025

Ukończenie studiów (Rzeczywisty)

31 grudnia 2025

Daty rejestracji na studia

Pierwszy przesłany

11 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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