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- Ensaio 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Barcelona
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Sant Joan Despí, Barcelona, Espanha, E-08970
- Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Distúrbios da micção
- Sintomas do Trato Urinário Inferior
- Manifestações Urológicas
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Adesão e Cumprimento do Tratamento
- Comportamento de saúde
- Conformidade do paciente
- Aceitação dos Cuidados de Saúde pelo Paciente
- Incontinencia urinaria
- Disfunção Sexual Fisiológica
- Adesão à Medicação
Outros números de identificação do estudo
- 21/14
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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