An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI) (HTAR-CSI)
11. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Aktiv 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. april 2021
Primær færdiggørelse (Faktiske)
15. april 2025
Studieafslutning (Faktiske)
31. december 2025
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
11. maj 2026
Først opslået (Faktiske)
15. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Vandladningsforstyrrelser
- Nedre urinvejssymptomer
- Urologiske manifestationer
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Behandlingsoverholdelse og compliance
- Sundhedsadfærd
- Patient Compliance
- Patientaccept af sundhedspleje
- Ufrivillig vandladning
- Seksuel dysfunktion, Fysiologisk
- Medicinadhærens
Andre undersøgelses-id-numre
- 21/14
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Results will be published, but individual participant data will not be shared.
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