Patient Decision Aids for Hypertension: A Pilot Study

NCT07017153 | Completed

• 1 other identifier: 260112024-ANF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

arterial hypertension; patient decision aid; shared decision making; decision aid; patient engagement; pilot study; adherence

Outcome Measures

Primary Outcomes (1)

• Patient-perceived usefulness of hypertension decision aids

  Patient-Perceived Usefulness of the Decision Aid (Measured by a Study-Specific Questionnaire adapted from the Multidimensional Measure of Informed Choice \[MMIC; DOI: 10.1016/S0738-3991(02)00089-7\], assessing relevance, clarity, and ease of use, aligning with questions addressing decision aids for arterial hypertension therapy)

  Up to 24 weeks

Secondary Outcomes (4)

• Knowledge

  Up to 24 weeks.

• Risk Perception

  Up to 24 Weeks

• Confidence in decision-making

  Up to 24 Weeks

• Preparation for decision making

  Up to 24 weeks

Study Arms (2)

Patient Decision Aid B

OTHER

Patients will receive Decision Aid B. Original: "How Do I Control My Blood Pressure? Lifestyle Options and Choices of Medicines". (NICE 2019. ISBN 978-1-4731-3543-7) German Translation for our Study: "Wie kann ich meinen Bluthochdruck behandeln? Optionen zu Lebensstiländerungen und der Medikamentenwahl"

Other: Questionnaire B

Patient Decision Aid A

OTHER

Patients will receive Decision Aid A. Original: "Bluthochdruck - Wie Herz-Kreislauf-Erkrankungen vorbeugen?". (SHARE TO CARE, 2025. https://entscheidungshilfe.share-to-care.de/bluthochdruck/ (access: 25.02.2025)) English translation: "Hypertension - How to Prevent Cardiovascular Diseases"

Other: Questionnaire A

Interventions

Questionnaire B OTHER

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

Patient Decision Aid B

Questionnaire A OTHER

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

Patient Decision Aid A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>18 years)
• Diagnosed with hypertension (all stages), regardless of primary reason for treatment.
• Receiving treatment at the Department of Internal Medicine I, University Hospital Brandenburg an der Havel

You may not qualify if:

• Patients under 18 years old
• Pregnancy-induced hypertension
• Patients unable to provide informed consent

Sponsors & Collaborators

• Medizinische Hochschule Brandenburg Theodor Fontane: lead

Study Sites (2)

Universitätsklinikum Brandenburg an der Havel, Hochstraße 29, 14770 Brandenburg an der Havel

Brandenburg, Brandenburg, 14770, Germany

Location

Institute for Health Services and Health System Research, Faculty of Health Science Brandenburg, Brandenburg Medical School (Theodor Fontane)

Rüdersdorf, Brandenburg, Germany

Location

Related Links

• Intervention Arm B: How do I control my blood pressure? Lifestyle options and choice of medicines Patient decision aid
• Intervention Arm A: Bluthochdruck - Wie Herz-Kreislauf-Erkrankungen vorbeugen? (user: Innovationsfonds\_SDM pw: Making\_SDM\_a\_Reality)
• World Health Organization: Hypertension
• International Patient Decision Aid Standards Collaboration: What are patient decision aids?
• Kim S, Shin DW, Yun JM, Hwang Y, Park SK, Ko YJ, Cho B. Medication Adherence and the Risk of Cardiovascular Mortality and Hospitalization Among Patients With Newly Prescribed Antihypertensive Medications. Hypertension. 2016 Mar;67(3):506-12. doi: 10.1161

MeSH Terms

Conditions

Hypertension; Patient Participation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student and Doctoral Candidate

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: June 12, 2025
• Study Start: February 27, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)