- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07589881
An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI) (HTAR-CSI)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona
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Sant Joan Despí, Barcelona, España, E-08970
- Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
Periodo de tiempo: 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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention
Periodo de tiempo: 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 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trastornos de la micción
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Incontinencia urinaria
- Disfunción Sexual Fisiológica
- Adherencia a la medicación
Otros números de identificación del estudio
- 21/14
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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