Adherence to Blood Pressure Diaries With Personalized Visuals

Neurovascular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06189378
• Other study ID #: 1249/2023
• Status: Completed
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: October 29, 2023

Study information

• Verified date: January 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 29, 2023
• Est. primary completion date: October 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurovascular Disorder

Intervention

Other:
• Inclusion of patient-provided pictures into blood pressure diaries
Patient-provided pictures with positive meaning were included into blood pressure diaries
• Conventional blood pressure diary
Conventional blood pressure diary

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Blood pressure	Mean raw values of systolic and diastolic blood pressure	28 days
Secondary	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)	28 days
Secondary	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
Secondary	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
Secondary	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