An interventional study of Educational Intervention for Adverse Drug Effects and routine care in Resistant Hypertension, Urinary Incontinence and Sexual Disfunction, sponsored by Consorci Sanitari Integral. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Consorci Sanitari Integral · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 46 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
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Exclusion Criteria:
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: * One-on-one sessions with trained nurse. * Education about common side effects of antihypertensives. * Techniques to reduce the impact of side effects. * Discussions around maintaining adherence to therapy. * Strategies for addressing issues related to sexual health and urinary continence.
Behavioral: Educational Intervention for Adverse Drug Effects
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.
Other: routine care
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: * One-on-one sessions with trained nurse. * Education about common side effects of antihypertensives. * Techniques to reduce the impact of side effects. * Discussions around maintaining adherence to therapy. * Strategies for addressing issues related to sexual health and urinary continence.
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.
Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
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.
Time frame: Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program.
Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention
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.
Time frame: 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
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.
Time frame: Adherence will be measured at baseline and post-intervention (at 6 months).
sexual dysfunction
Standardized questionnaires related to sexual health (for example, Sexual Health Inventory for Men (SHIM)
Time frame: At baseline and 6 months after the intervention.
urinary incontinence
Standardized questionnaires will be applied to assess and urinary incontinence (for example, Incontinence Quality of Life (I-QOL)).
Time frame: At baseline and 6 months after the intervention.
Plan to share: No — Results will be published, but individual participant data will not be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Consorci Sanitari Integral