Neurovascular DisorderNCT06189378
Adherence to Blood Pressure Diaries With Personalized Visuals
A study testing Inclusion of patient-provided pictures into blood pressure diaries and Conventional blood pressure diary in people with Neurovascular Disorder, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurovascular Disorder
- What is being tested?
- Inclusion of patient-provided pictures into blood pressure diaries and Conventional blood pressure diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jul 2023to 29 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of TIA or stroke (ischemic or hemorrhagic) upon admission.
Who cannot join
- Modified Rankin Scale score of ≥4 at inclusion
- Inability to provide informed consent
- Pre-existing legal guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurovascular Disorder
- Being tested
- Inclusion of patient-provided pictures into blood pressure diaries, Conventional blood pressure diary
- Keywords
- adherence, blood pressure diary, stroke, TIA
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusion of patient-provided pictures into blood pressure diariesOther
Patient-provided pictures with positive meaning were included into blood pressure diaries
Conventional blood pressure diaryOther
Conventional blood pressure diary
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Conventional blood pressure diary |
| 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. Receives: Other: Inclusion of patient-provided pictures into blood pressure diaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (5)
Blood pressure
Mean raw values of systolic and diastolic blood pressure
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start7 Jul 2023
- Primary completion29 Oct 2023
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurovascular DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Farr, Medical University of Vienna
- Investigators
- Clemens Farr, MD PHD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189378
- Sponsor's protocol ID
- 1249/2023
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request and through our local ERB.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Picture This: A Randomized Controlled Pilot Study Investigating Adherence to Blood Pressure Diaries With Personalized Visuals
- ClinicalTrials.gov ID
- NCT06189378
- Acronym / sponsor ID
- 1249/2023
- Conditions
- Neurovascular Disorder
- Keywords
- adherence, blood pressure diary, stroke, TIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 29 Oct 2023 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional blood pressure diary | Active comparator | Other: Conventional blood pressure diaryBlood 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. |
| Blood pressure diary including patient-provided pictures | Experimental | Other: Inclusion of patient-provided pictures into blood pressure diariesIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of TIA or stroke (ischemic or hemorrhagic) upon admission.
Key exclusion criteria (3 listed)
- Modified Rankin Scale score of ≥4 at inclusion
- Inability to provide informed consent
- Pre-existing legal guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inclusion of patient-provided pictures into blood pressure diariesPatient-provided pictures with positive meaning were included into blood pressure diaries | Other | Blood pressure diary including patient-provided pictures |
| Conventional blood pressure diaryConventional blood pressure diary | Other | Conventional blood pressure diary |
Primary outcome
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.
5 secondary outcomes
Blood pressure
Time frame: 28 days
Precision of documentation of blood pressure
Time frame: 28 days
Patient Global Impression of Change Scale
Time frame: 28 days
36-Item Short Form Health Survey
Time frame: 28 days
Hospital Anxiety and Depression Scale
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request and through our local ERB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens Farr, MD PHD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclusion of patient-provided pictures into blood pressure diaries and Conventional blood pressure diary in people with Neurovascular Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.