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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclusion of patient-provided pictures into blood pressure diaries | Other | Patient-provided pictures with positive meaning were included into blood pressure diaries |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Mean raw values of systolic and diastolic blood pressure | 28 days |
| Precision of documentation of blood pressure | The proportion of documented values ending with "0" or "5" served to assess the extent of rounding (i.e. the precision of documentation) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory endpoints | 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. | 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Farr, MD PHD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
Data will be shared upon reasonable request and through our local ERB.
Upon request and for 1 month
reasonable request and upon approval of our local ERB
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional blood pressure diary | Other | Conventional blood pressure diary |
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| 28 days |
| Patient Global Impression of Change Scale | 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. | 28 days |
| 36-Item Short Form Health Survey | 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. | 28 days |
| Hospital Anxiety and Depression Scale | 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. | 28 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |