Adherence to Blood Pressure Diaries With Personalized Visuals

NCT06189378 | Completed

• 1 other identifier: 1249/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial randomizes patients with a neurovascular diagnosis to a type of blood pressure diary for secondary stroke prevention (conventional blood pressure diary or blood pressure diary including patient-provided images). Outcomes include adherence and patient-reported outcomes.

Conditions

Neurovascular Disorder

Keywords

adherence; blood pressure diary; stroke; TIA

Outcome Measures

Primary Outcomes (1)

• Adherence

  The primary endpoint was adherence to blood pressure diaries defined as the number of complete blood pressure measurements (maximum of two per day) divided by the maximum number of measures over the study period (28 days, resulting in a maximum total of 56 measurements). Complete entries were defined as diary entries stating date, time and systolic as well as diastolic blood pressure.

  28 days

Secondary Outcomes (5)

• Blood pressure

  28 days

• Precision of documentation of blood pressure

  28 days

• Patient Global Impression of Change Scale

  28 days

• 36-Item Short Form Health Survey

  28 days

• Hospital Anxiety and Depression Scale

  28 days

Other Outcomes (1)

• Exploratory endpoints

  28 days

Study Arms (2)

Conventional blood pressure diary

ACTIVE COMPARATOR

Blood pressure diaries consisted of tables including columns for date, time as well as systolic and diastolic blood pressure respectively (1 page for 1 week) printed on the right-hand pages of an A5 (ISO 216 format) booklet.

Other: Conventional blood pressure diary

Blood pressure diary including patient-provided pictures

EXPERIMENTAL

In the interventional arm pictures chosen by patients were provided over a secure online connection by patients in this group and inserted into the left-hand-pages of the blood pressure diaries.

Other: Inclusion of patient-provided pictures into blood pressure diaries

Interventions

Inclusion of patient-provided pictures into blood pressure diaries OTHER

Patient-provided pictures with positive meaning were included into blood pressure diaries

Blood pressure diary including patient-provided pictures

Conventional blood pressure diary OTHER

Conventional blood pressure diary

Conventional blood pressure diary

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of TIA or stroke (ischemic or hemorrhagic) upon admission.

You may not qualify if:

• Inability to provide informed consent
• Pre-existing legal guardianship.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clemens Farr, MD PHD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 3, 2024
• Study Start: July 7, 2023
• Primary Completion: October 29, 2023
• Study Completion: October 29, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon request and for 1 month
• Access Criteria: reasonable request and upon approval of our local ERB

Locations

AU (1)