An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI) (HTAR-CSI)
11. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
46
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Barcelona
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Sant Joan Despí, Barcelona, Spanien, E-08970
- Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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:
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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:
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Aktiver 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
Zeitfenster: Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program.
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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.
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Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention
Zeitfenster: 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.
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Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program
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Medication Adherence Rate
Zeitfenster: Adherence will be measured at baseline and post-intervention (at 6 months).
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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.
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Adherence will be measured at baseline and post-intervention (at 6 months).
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sexual dysfunction
Zeitfenster: At baseline and 6 months after the intervention.
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Standardized questionnaires related to sexual health (for example, Sexual Health Inventory for Men (SHIM)
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At baseline and 6 months after the intervention.
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urinary incontinence
Zeitfenster: At baseline and 6 months after the intervention.
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Standardized questionnaires will be applied to assess and urinary incontinence (for example, Incontinence Quality of Life (I-QOL)).
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At baseline and 6 months after the intervention.
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. April 2021
Primärer Abschluss (Tatsächlich)
15. April 2025
Studienabschluss (Tatsächlich)
31. Dezember 2025
Studienanmeldedaten
Zuerst eingereicht
11. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Mai 2026
Zuerst gepostet (Tatsächlich)
15. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Mai 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Männliche Urogenitalerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Störungen beim Wasserlassen
- Symptome der unteren Harnwege
- Urologische Manifestationen
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Anzeichen und Symptome
- Therapietreue und Compliance
- Gesundheitsverhalten
- Zuverlässigkeit des Patienten
- Patientenakzeptanz der Gesundheitsversorgung
- Harninkontinenz
- Sexuelle Dysfunktion, Physiologisch
- Medikamentenhaftung
Andere Studien-ID-Nummern
- 21/14
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Results will be published, but individual participant data will not be shared.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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