Resistant Hypertension, Sexual Disfunction, Urinary Incontinence
Conditions
Keywords
Resistant hypertension, Sexual dysfunction, Nurse-led intervention, Educational intervention, Ambulatory Blood Pressure Monitoring (ABPM), Medication Adherence, Adverse Effects of Antihypertensive Drugs, urinary health
Brief summary
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.
Interventions
BEHAVIORALEducational Intervention for Adverse Drug Effects
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.
OTHERroutine care
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.
Sponsors
Consorci Sanitari Integral
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention | 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. |
| Medication Adherence Rate | 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. |
| sexual dysfunction | At baseline and 6 months after the intervention. | Standardized questionnaires related to sexual health (for example, Sexual Health Inventory for Men (SHIM) |
| urinary incontinence | 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)). |
Countries
Spain
Outcome results
None listed