Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
Sant Joan Despí, Barcelona, E-08970, Spain
NCT Number: NCT07589881
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Sant Joan Despí, Barcelona, E-08970, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and 6 months after the intervention.
Standardized questionnaires related to sexual health (for example, Sexual Health Inventory for Men (SHIM)
Time frame: 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)).
Consorci Sanitari Integral
Other
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.
Acronym: HTAR-CSI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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