Adherence to Blood Pressure Diaries With Personalized Visuals
January 6, 2024 updated by: Clemens Farr, Medical University of Vienna
Picture This: A Randomized Controlled Pilot Study Investigating 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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vienna, Austria, 1090
- Medical University of Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
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Conventional blood pressure diary
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Experimental: Blood pressure diary including patient-provided pictures
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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Patient-provided pictures with positive meaning were included into blood pressure diaries
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: 28 days
|
Mean raw values of systolic and diastolic blood pressure
|
28 days
|
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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)
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28 days
|
|
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.
|
28 days
|
|
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.
|
28 days
|
|
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.
|
28 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clemens Farr, MD PHD, Medical University of Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2023
Primary Completion (Actual)
October 29, 2023
Study Completion (Actual)
October 29, 2023
Study Registration Dates
First Submitted
December 8, 2023
First Submitted That Met QC Criteria
December 18, 2023
First Posted (Actual)
January 3, 2024
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
January 6, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1249/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be shared upon reasonable request and through our local ERB.
IPD Sharing Time Frame
Upon request and for 1 month
IPD Sharing Access Criteria
reasonable request and upon approval of our local ERB
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.