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Patient Decision Aids for Hypertension: A Pilot Study

NCT07017153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-12

No results posted yet for this study

Summary

Background: Arterial hypertension is a major global health problem with a leading cause of premature death and a major risk factor for cardiovascular disease. Despite its prevalence, blood pressure control remains suboptimal, requiring effective treatment and patient engagement strategies. With the increasing emphasis on person-centered care, healthcare professionals and patients are moving toward shared decision-making (SDM), which is defined as an approach to collaboratively making health decisions in line with recent evidence and patient preferences and values. Patient decision aids (PDAs) are tools designed to involve patients in treatment decisions by providing clear information about options, benefits and risks, while helping them to clarify personal values. These tools have been shown to improve decision quality, adherence and health outcomes.

Methods: This pilot study aims to evaluate the practical utility of two PDAs with different formats for antihypertensive therapy from the patient's perspective. Adult patients (≥ 18 years) with hypertension admitted to a university hospital will be randomized to use one of the two PDAs displayed on a tablet. After viewing the PDA, participants will complete a questionnaire assessing their knowledge, risk perception, preferences, and involvement in decision-making. Descriptive statistics will be used to analyze the data.

Expected results: The study anticipates that the PDAs will increase patients knowledge of treatment options, support value clarification and improve engagement in SDM. These findings will inform the design of a larger randomized controlled trial to optimize PDA formats for hypertension management.

Conditions

  • Patient Decision Aid

Interventions

OTHER

Questionnaire B

Questionnaire regarding patient decision aid: How Do I Control My Blood Pressure? Lifestyle Options and Choices of Medicines.

OTHER

Questionnaire A

Questionnaire regarding patient decision aid: Hypertension - How to Prevent Cardiovascular Diseases

Sponsors & Collaborators

  • Medizinische Hochschule Brandenburg Theodor Fontane

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-27
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017153 on ClinicalTrials.gov