Neurovascular Disorder
Conditions
Keywords
adherence, blood pressure diary, stroke, TIA
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.
Interventions
OTHERInclusion of patient-provided pictures into blood pressure diaries
Patient-provided pictures with positive meaning were included into blood pressure diaries
OTHERConventional blood pressure diary
Conventional blood pressure diary
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 28 days | Mean raw values of systolic and diastolic blood pressure |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory endpoints | 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. |
Countries
Austria
Outcome results
None listed