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Completed

NCT Number: NCT06189378

Adherence to Blood Pressure Diaries With Personalized Visuals

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.

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Key information

Conditions

Neurovascular Disorder Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Inclusion of patient-provided pictures into blood pressure diaries

Other

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

Conventional blood pressure diary

Other

Conventional blood pressure diary

Primary outcomes

  1. Adherence

    Time frame: 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 outcomes

  1. Blood pressure

    Time frame: 28 days

    Mean raw values of systolic and diastolic blood pressure

  2. Precision of documentation of blood pressure

    Time frame: 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)

  3. Patient Global Impression of Change Scale

    Time frame: 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.

  4. 36-Item Short Form Health Survey

    Time frame: 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.

  5. Hospital Anxiety and Depression Scale

    Time frame: 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.

Other outcomes

  1. Exploratory endpoints

    Time frame: 28 days

    Exploratory endpoints evolved around patients' perspectives on blood pressure diaries as assessed by an empirical survey (13 questions in each group) conceived for this study. Possible answers were Likert-type scales, yes/no or open commentaries.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Picture This: A Randomized Controlled Pilot Study Investigating Adherence to Blood Pressure Diaries With Personalized Visuals

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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