Clinical trial NCT05388578: The Stroke Box: a Patient-centered eHealth Approach for Improving Post-stroke Care.
Official title: The Stroke Box: a Patient-centered eHealth Approach for Improving Post-stroke Care.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke
eHealth
The Box
Atrial Fibrillation
Hypertension
Lifestyle
Primary Care
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Blood pressure progression
timeFrame: 6 months
Secondary outcomes:
measure: Heart rhythm progression
timeFrame: 6 months
measure: User evaluation of the self-measurements
timeFrame: 6 months
measure: Patient adherence
timeFrame: 6 months
measure: Technical implementation
timeFrame: 6 months
measure: User evaluation of the implementaion
timeFrame: 6 months
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Marieke JH Wermer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: