StrokeNCT05388578
The Stroke Box: a Patient-centered eHealth Approach for Improving Post-stroke Care.
An observational study of Stroke, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Although there have been major advances in (personalized) stroke treatment in the last decade, the need for prevention of stroke remains critical. Prevention of recurrent stroke is currently primarily organized through management of cardiovascular risk factors including lifestyle, hypertension and atrial fibrillation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Blood pressure monitor, Weighting scale and Activity tracker
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jul 2022to 1 Jul 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: We will recruit patients visiting for a TIA or admitted for an ischemic or haemorrhagic stroke in the LUMC.
Who may be able to join
- The patient is admitted with a clinical diagnosis of a TIA, ischemic or haemorrhagic stroke in the LUMC
- The patient is able to communicate in Dutch (patients with severe aphasia - defined as not being able to respond to the questionnaires or perform the self-measurements - are excluded)
- The patient is at least 18 years of age
- The patient will be discharged from the hospital directly to home
- The patient has hypertension during hospital admission as defined by systolic blood pressure >140mmHg during two separate blood pressure measurements
- The patient has a suitable smartphone and is able to use it in a reasonable sense
Who cannot join
- The patient does not have internet access at home
- Patient is unwilling to sign the informed consent form
- Patient is considered an incapacitated adult
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2300RC
Hermes AJ Spaink, MSc, h.a.j.spaink@lumc.nl
Marieke JH Wermer, MD PhD
About this study
Although there have been major advances in (personalized) stroke treatment in the last decade, the need for prevention of stroke remains critical. Prevention of recurrent stroke is currently primarily organized through management of cardiovascular risk factors including lifestyle, hypertension and atrial fibrillation (AF). To improve the cardiovascular risk management of stroke patients, more frequent measurements of blood pressure and heart rhythm are essential. In addition, actively engaging the patient with their own recovery could lead to an improved lifestyle. Recent studies have shown telemonitoring of patients can improve care, help with prevention of disease, and reduce healthcare costs, whilst keeping the patient more engaged with their disease.
The LUMC "Box" has shown to effectively monitor blood pressure of patients after myocardial infarction with equal results and patient satisfaction rates compared to standard care with less physical contact moments. We plan to use this framework for improving post-stroke care by introducing more frequent blood pressure and heart rhythm measurements. Additionally, we will provide more information around lifestyle improvement and have the patient actively engage with their weight and physical activity.
In this study we will be evaluating the technical feasibility and clinical implementation of the home-based self-measurements using the Box in a post-stroke pilot setting: the Stroke Box. The results will be used as a basis for the power calculation for a future randomized clinical trial on the effect of the BOX on hypertension treatment and AF detection.
Read the detailed description
Objective: The overall aim of this pilot is to evaluate the technical feasibility and clinical implementation of the Stroke Box by evaluating user experience and hypertension management. The primary objective is gathering data on blood pressure management for power calculation for a future randomized clinical trial where the effect of the Stroke Box on hypertension management and AF detection will be studied. The secondary objectives will be gathering and evaluating data on heart rhythm, weight and activity of patients using the Stroke Box, evaluating the technical- and workflow implementation for healthcare professionals, evaluating the self-management and user-experience of patients, assessing the patient adherence to the self-measurements and pharmacotherapeutic prophylactic therapy, and evaluating the correct functioning of the IT infrastructure, hardware and LUMC Care app, and to assess the correct use of all stakeholders involved in the eHealth support and telemonitoring with the Stroke Box.
Study design: This study is a prospective cohort study to evaluate the implementation of the Stroke Box and gather data. For the first 5 patients we will mainly evaluate the technical procedures of the study in addition to the other objectives. For the remainder, we will be gathering data on blood pressure management, patient engagement and have a user-based evaluation of the eHealth infrastructure during a six-month follow-up period. We will do evaluations of the collected data based on a before-after comparison of blood pressure and questionnaire results.
Study population: Patients admitted for a TIA, ischemic or haemorrhagic stroke in the LUMC. We will include 55 patients in total of which in the first 5 patients we specifically focus on testing and evaluating the technical feasibility.
Intervention (if applicable): The Stroke Box will contain a blood pressure monitor, weighting scale, single-lead ECG wristwatch with activity tracking and associated apps. Patients are asked to measure the associated factors on a daily basis. In addition, all patients will be asked to fill in a questionnaire at the start and the end of the study. Patients will participate for 6 months in the pilot.
Main study parameters/endpoints: The primary objective of this study is the gathering of data on blood pressure management as a basis for power analysis in future trials. The secondary objectives will be gathering and evaluating data on heart rhythm, weight and activity of patients, evaluating the technical- and workflow implementation for healthcare professionals, evaluating the self-management and user-experience of patients, assessing the patient adherence to the self-measurements and pharmacotherapeutic prophylactic therapy, and finally evaluating the technical feasibility for all stakeholders.
- Conditions
- Stroke
- Being tested
- Blood pressure monitor, Weighting scale, Activity tracker, ECG device
- Keywords
- stroke, eHealth, The Box, Atrial Fibrillation, Hypertension, Lifestyle, Primary Care
- Medical subject headings
- Stroke, Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure monitorDevice
Participants will receive the Withings BPM connect monitor and do weekly self-measurements of blood pressure.
Weighting scaleDevice
Participants will receive the Withings Body scale and do weekly self-measurements of their body weight and BMI.
Activity trackerDevice
Participants will receive the Withings Move to automatically keep track of their number of steps and activity type.
ECG deviceDevice
Participants will receive the Withings Move ECG to make daily measurements of heart rhythm, an algorithm will detect abnormalities in heart rhythm such as atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | All participants will receive the Stroke Box containing a wearable bloodpressure monitor, activity tracker and weighting scale, and associated apps. Receives: Device: Blood pressure monitor; Device: Weighting scale; Device: Activity tracker | |
| Patients with indication for AF | All participants will receive the Stroke Box containing a wearable bloodpressure monitor, activity tracker and weighting scale, and associated apps. Patients with an indication for atrial fibrillation (AF) will additionally receive a wrist-worn single-lead ECG device. Receives: Device: Blood pressure monitor; Device: Weighting scale; Device: Activity tracker; Device: ECG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure progression
Gathering data on self-measured blood pressure and AF detection of patients using the Stroke Box as a basis for power analysis of a future randomized controlled clinical trial and performing a quality assessment of the collected data.
Measured: 6 months
Secondary outcomes (5)
Heart rhythm progression
Gathering data on self-measured heart rhythm, weight and activity of patients using the Stroke Box, and performing a quality assessment of the collected data.
Measured: 6 months
User evaluation of the self-measurements
Evaluation of the potential change in self-management, patient engagement and user experience of the patients using the Stroke Box, using questionnaires. Measured using the mHealth App Usability Questionnaire (MAUQ) with scales between 1 - 7, where lower scores indicate a better user experience.
Measured: 6 months
Patient adherence
Assessment of patient adherence to the self-measurements and pharmacotherapeutic prophylactic therapy, using questionnaires. Measured using the Partners In Healthcare (PIH) questionnaire with scales between 0 - 8, where a higher score indicates more knowledge of or involvement with of the patient's disorder and recovery.
Measured: 6 months
Technical implementation
To evaluate the correct functioning of the IT infrastructure, hardware and LUMC Care app, and to assess the correct use of all stakeholders involved in the eHealth support and telemonitoring with the Stroke Box.
Measured: 6 months
User evaluation of the implementaion
User based evaluation of the technical - and workflow implementation for healthcare professionals using the Stroke Box, using questionnaires. Evaluated with the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) questionnaires for healthcare professionals with scales between 1 - 7, where lower scores indicate a better experience.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start7 Jul 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marieke JH Wermer, MD, Leiden University Medical Center
- Investigators
- Marieke JH Wermer, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388578
- Sponsor's protocol ID
- P21.113
- Status last verified
- Aug 2022
- First submitted
- 19 May 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stroke Box: a Patient-centered eHealth Approach for Improving Post-stroke Care.
- ClinicalTrials.gov ID
- NCT05388578
- Acronym / sponsor ID
- P21.113
- Conditions
- Stroke
- Keywords
- stroke, eHealth, The Box, Atrial Fibrillation, Hypertension, Lifestyle, Primary Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 24 May 2022 (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.
Although there have been major advances in (personalized) stroke treatment in the last decade, the need for prevention of stroke remains critical. Prevention of recurrent stroke is currently primarily organized through management of cardiovascular risk factors including lifestyle, hypertension and atrial fibrillation (AF). To improve the cardiovascular risk management of stroke patients, more frequent measurements of blood pressure and heart rhythm are essential. In addition, actively engaging the patient with their own recovery could lead to an improved lifestyle. Recent studies have shown telemonitoring of patients can improve care, help with prevention of disease, and reduce healthcare costs, whilst keeping the patient more engaged with their disease.
The LUMC "Box" has shown to effectively monitor blood pressure of patients after myocardial infarction with equal results and patient satisfaction rates compared to standard care with less physical contact moments. We plan to use this framework for improving post-stroke care by introducing more frequent blood pressure and heart rhythm measurements. Additionally, we will provide more information around lifestyle improvement and have the patient actively engage with their weight and physical activity.
In this study we will be evaluating the technical feasibility and clinical implementation of the home-based self-measurements using the Box in a post-stroke pilot setting: the Stroke Box. The results will be used as a basis for the power calculation for a future randomized clinical trial on the effect of the BOX on hypertension treatment and AF detection.
Detailed description
Objective: The overall aim of this pilot is to evaluate the technical feasibility and clinical implementation of the Stroke Box by evaluating user experience and hypertension management. The primary objective is gathering data on blood pressure management for power calculation for a future randomized clinical trial where the effect of the Stroke Box on hypertension management and AF detection will be studied. The secondary objectives will be gathering and evaluating data on heart rhythm, weight and activity of patients using the Stroke Box, evaluating the technical- and workflow implementation for healthcare professionals, evaluating the self-management and user-experience of patients, assessing the patient adherence to the self-measurements and pharmacotherapeutic prophylactic therapy, and evaluating the correct functioning of the IT infrastructure, hardware and LUMC Care app, and to assess the correct use of all stakeholders involved in the eHealth support and telemonitoring with the Stroke Box.
Study design: This study is a prospective cohort study to evaluate the implementation of the Stroke Box and gather data. For the first 5 patients we will mainly evaluate the technical procedures of the study in addition to the other objectives. For the remainder, we will be gathering data on blood pressure management, patient engagement and have a user-based evaluation of the eHealth infrastructure during a six-month follow-up period. We will do evaluations of the collected data based on a before-after comparison of blood pressure and questionnaire results.
Study population: Patients admitted for a TIA, ischemic or haemorrhagic stroke in the LUMC. We will include 55 patients in total of which in the first 5 patients we specifically focus on testing and evaluating the technical feasibility.
Intervention (if applicable): The Stroke Box will contain a blood pressure monitor, weighting scale, single-lead ECG wristwatch with activity tracking and associated apps. Patients are asked to measure the associated factors on a daily basis. In addition, all patients will be asked to fill in a questionnaire at the start and the end of the study. Patients will participate for 6 months in the pilot.
Main study parameters/endpoints: The primary objective of this study is the gathering of data on blood pressure management as a basis for power analysis in future trials. The secondary objectives will be gathering and evaluating data on heart rhythm, weight and activity of patients, evaluating the technical- and workflow implementation for healthcare professionals, evaluating the self-management and user-experience of patients, assessing the patient adherence to the self-measurements and pharmacotherapeutic prophylactic therapy, and finally evaluating the technical feasibility for all stakeholders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | Device: Blood pressure monitor, Device: Weighting scale, Device: Activity trackerAll participants will receive the Stroke Box containing a wearable bloodpressure monitor, activity tracker and weighting scale, and associated apps. |
| Patients with indication for AF | – | Device: Blood pressure monitor, Device: Weighting scale, Device: Activity tracker, Device: ECG deviceAll participants will receive the Stroke Box containing a wearable bloodpressure monitor, activity tracker and weighting scale, and associated apps. Patients with an indication for atrial fibrillation (AF) will additionally receive a wrist-worn single-lead ECG device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We will recruit patients visiting for a TIA or admitted for an ischemic or haemorrhagic stroke in the LUMC.
Key inclusion criteria (6 listed)
- The patient is admitted with a clinical diagnosis of a TIA, ischemic or haemorrhagic stroke in the LUMC
- The patient is able to communicate in Dutch (patients with severe aphasia - defined as not being able to respond to the questionnaires or perform the self-measurements - are excluded)
- The patient is at least 18 years of age
- The patient will be discharged from the hospital directly to home
- The patient has hypertension during hospital admission as defined by systolic blood pressure >140mmHg during two separate blood pressure measurements
Key exclusion criteria (3 listed)
- The patient does not have internet access at home
- Patient is unwilling to sign the informed consent form
- Patient is considered an incapacitated adult
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 |
|---|---|---|
| Blood pressure monitorParticipants will receive the Withings BPM connect monitor and do weekly self-measurements of blood pressure. | Device | Patients with indication for AF, Primary cohort |
| Weighting scaleParticipants will receive the Withings Body scale and do weekly self-measurements of their body weight and BMI. | Device | Patients with indication for AF, Primary cohort |
| Activity trackerParticipants will receive the Withings Move to automatically keep track of their number of steps and activity type. | Device | Patients with indication for AF, Primary cohort |
| ECG deviceParticipants will receive the Withings Move ECG to make daily measurements of heart rhythm, an algorithm will detect abnormalities in heart rhythm such as atrial fibrillation. | Device | Patients with indication for AF |
Primary outcome
Blood pressure progression
Time frame: 6 months
Gathering data on self-measured blood pressure and AF detection of patients using the Stroke Box as a basis for power analysis of a future randomized controlled clinical trial and performing a quality assessment of the collected data.
5 secondary outcomes
Heart rhythm progression
Time frame: 6 months
User evaluation of the self-measurements
Time frame: 6 months
Patient adherence
Time frame: 6 months
Technical implementation
Time frame: 6 months
User evaluation of the implementaion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
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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.
Marieke JH Wermer, MD PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Leiden University Medical Center at 1 site in Netherlands.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hermes AJ Spaink, MSc (+31 71 5262 547, h.a.j.spaink@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure progression (time frame: 6 months). 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 12 Aug 2022.