An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI) (HTAR-CSI)
11 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
46
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Barcelona
-
Sant Joan Despí, Barcelona, Espagne, E-08970
- Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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:
|
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:
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 avril 2021
Achèvement primaire (Réel)
15 avril 2025
Achèvement de l'étude (Réel)
31 décembre 2025
Dates d'inscription aux études
Première soumission
11 mai 2026
Première soumission répondant aux critères de contrôle qualité
11 mai 2026
Première publication (Réel)
15 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Troubles urinaires
- Symptômes des voies urinaires inférieures
- Manifestations urologiques
- Conditions pathologiques, signes et symptômes
- Comportement
- Signes et symptômes
- Adhésion et conformité au traitement
- Comportement de santé
- L'observance du patient
- Acceptation des soins de santé par le patient
- Incontinence urinaire
- Dysfonction sexuelle, physiologique
- Adhésion aux médicaments
Autres numéros d'identification d'étude
- 21/14
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Results will be published, but individual participant data will not be shared.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .