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

NCT05388578 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2022-08-12

No results posted yet for this study

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

Interventions

DEVICE

Blood pressure monitor

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

DEVICE

Weighting scale

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

DEVICE

Activity tracker

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

DEVICE

ECG 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.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Marieke JH Wermer, MD PhD · Leiden University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388578 on ClinicalTrials.gov