Adherence to Blood Pressure Diaries With Personalized Visuals

Not Applicable

Completed

• Conditions: Neurovascular Disorder
• Interventions: Other: Conventional blood pressure diary; Other: Inclusion of patient-provided pictures into blood pressure diaries

• Registration Number: NCT06189378
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

In this prospective trial, the investigators randomized persons with diagnoses of stroke or transitoric ischemic attack into two groups: (i) 10 patients received a personalized blood pressure diary with pictures of their choosing. (ii) 10 patients received a blood pressure diary without photographs. The investigators instructed participants in either group to document their blood pressure at home twice daily over twenty-eight days.

Study Timeline

• Study Start: 2023-07-07
• Primary Completion: 2023-10-29
• Study Completion: 2023-10-29
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-18
• Status Verified: 2024-01
• Study First Posted: 2024-01-03
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• Modified Rankin Scale score of ≥4 at inclusion
• Inability to provide informed consent
• Pre-existing legal guardianship.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional blood pressure diary	Conventional blood pressure diary	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.
Blood pressure diary including patient-provided pictures	Inclusion of patient-provided pictures into blood pressure diaries	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.

Primary Outcome Measures

Name	Time	Method
Adherence	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	28 days	Mean raw values of systolic and diastolic blood pressure
Patient Global Impression of Change Scale	28 days	The Patient Global Impression of Change Scale is a self-report rating scale of 1 item on a Likert scale (maximum 7, higher score is better) and 1 item on a scale from 0-10 (higher score is worse). It was applied to assess patient satisfaction.
Hospital Anxiety and Depression Scale	28 days	The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a Likert scale. It is designed to measure anxiety and depression (7 items for each subscale). The maximum amount of points in each subscale is 21. More points are worse.
Precision of documentation of blood pressure	28 days	The proportion of documented values ending with "0" or "5" served to assess the extent of rounding (i.e. the precision of documentation)
36-Item Short Form Health Survey	28 days	The 36-Item Short Form Health Survey is a self-report survey of items on a Likert Scale in 8 domains. It is designed to assess quality of life. The maximum amount of points is 100. More points are better.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria