The Stroke Box: a Patient-centered eHealth Approach for Improving Post-stroke Care.

NCT05388578 | Unknown DMC

• 1 other identifier: P21.113
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Stroke

Keywords

stroke; eHealth; The Box; Atrial Fibrillation; Hypertension; Lifestyle; Primary Care

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Heart rhythm progression

  6 months

• User evaluation of the self-measurements

  6 months

• Patient adherence

  6 months

• Technical implementation

  6 months

• User evaluation of the implementaion

  6 months

Study Arms (2)

Primary cohort

All participants will receive the Stroke Box containing a wearable bloodpressure monitor, activity tracker and weighting scale, and associated apps.

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.

Device: Blood pressure monitor; Device: Weighting scale; Device: Activity tracker; Device: ECG device

Interventions

Blood pressure monitor DEVICE

Participants will receive the Withings BPM connect monitor and do weekly self-measurements of blood pressure.

Patients with indication for AF; Primary cohort

Weighting scale DEVICE

Participants will receive the Withings Body scale and do weekly self-measurements of their body weight and BMI.

Patients with indication for AF; Primary cohort

Activity tracker DEVICE

Participants will receive the Withings Move to automatically keep track of their number of steps and activity type.

Patients with indication for AF; Primary cohort

ECG device DEVICE

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.

Patients with indication for AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit patients visiting for a TIA or admitted for an ischemic or haemorrhagic stroke in the LUMC.

You may qualify if:

• 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

You may not qualify if:

• The patient does not have internet access at home
• Patient is unwilling to sign the informed consent form
• Patient is considered an incapacitated adult

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2300RC, Netherlands

RECRUITING

MeSH Terms

Conditions

Stroke; Atrial Fibrillation; Hypertension

Interventions

Blood Pressure Monitors; Fitness Trackers

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Marieke JH Wermer, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermes AJ Spaink, MSc

CONTACT

+31 71 5262 547; h.a.j.spaink@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Marieke J.H. Wermer

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: July 7, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)