What is the mechanism of action of this treatment?

The most common treatments for Deep Vein Thrombosis (DVT) are anticoagulants, which include medications like low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs) such as rivaroxaban and apixaban, and warfarin. These drugs work by inhibiting various factors in the blood coagulation pathway, thereby preventing the formation of new clots and the growth of existing ones. This is crucial for DVT patients as it reduces the risk of complications such as pulmonary embolism and post-thrombotic syndrome. Monitoring tools, like the Apple Watch, can play a significant role in early detection and management by tracking physiological changes that may indicate clot formation, thus allowing for timely medical intervention.

What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include direct oral anticoagulants (DOACs) like rivaroxaban and apixaban, low-molecular-weight heparin (LMWH), and warfarin. The primary side effect of these anticoagulants is an increased risk of bleeding, which can range from minor bruising to severe, life-threatening hemorrhages. DOACs are generally associated with fewer dietary restrictions and less frequent monitoring compared to warfarin, but they still carry a significant bleeding risk. LMWH can cause injection site reactions and, rarely, heparin-induced thrombocytopenia (HIT). Warfarin requires regular blood monitoring and can interact with various foods and medications, complicating its management.

What prior FDA approvals exist?

FDA-approved treatments for Deep Vein Thrombosis (DVT) include anticoagulants such as warfarin, low-molecular-weight heparins (e.g., enoxaparin), and direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, apixaban, and edoxaban. These medications help prevent clot formation and reduce the risk of complications. The Apple Watch Monitoring trial, which collects data on walking, heart rate, breathing, and sleep, could potentially enhance the management of DVT by predicting complications and optimizing anticoagulant therapy.

What other types of research exist?

Promising alternatives to Apple Watch for monitoring DVT patients in 2024 include: 1) Fitbit Sense 2, which offers advanced heart rate monitoring, ECG, and stress management features; 2) Garmin Venu 2 Plus, known for its comprehensive health tracking, including respiration and pulse oximetry; 3) Withings ScanWatch, which combines medical-grade ECG and SpO2 sensors with sleep apnea detection; and 4) BioIntelliSense BioSticker, a medical-grade wearable that continuously monitors vital signs and provides predictive analytics for early detection of health issues.

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Apple Watch Monitoring for Glioblastoma

N/A

Recruiting

Led By Andrew Dhawan, MD, DPhil

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

at least 18 years of age at the time of study enrolment

Karnofsky Performance Status (KPS) ≥ 70% at time of study enrolment

Must not have

under 18 years of age at the time of study enrolment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses the Apple Watch and an iPhone app to monitor glioblastoma patients' health data continuously. The goal is to detect early signs of complications by analyzing patterns in heart rate, breathing, movement, and sleep. This could help predict problems before they happen. The Apple Watch has been increasingly integrated into health care for monitoring heart rate and other health metrics, with studies suggesting its potential usefulness in detecting conditions like atrial fibrillation and monitoring cardiac health.

Who is the study for?

This trial is for adults over 18 with glioblastoma, either newly-diagnosed or recurrent, who are undergoing treatment or surveillance. Participants need to understand the consent form, have an iPhone to use with the Apple Watch app, and be physically active enough (KPS ≥ 70%). It's not for those under 18, unable to consent due to language barriers, without an iPhone, having wrist tattoos/skin conditions affecting the watch sensor or unable to wear the watch consistently.

What is being tested?

The study tests if measurements from an Apple Watch—like walking data, heart rate, breathing rate and sleep patterns—can relate to how patients feel during treatment changes. The goal is using this data to predict complications or symptom changes in advance.

What are the potential side effects?

There are no direct medical side effects from participating as it involves monitoring through an Apple Watch. However, participants may experience discomfort wearing the device consistently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am mostly able to care for myself and carry out daily activities.

Select...

I have a new or returning glioblastoma and am under treatment or watchful waiting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Success rate of 16-hour wear-time

Symptom collection success rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Wearing the Apple watch and the associated logging of health dataExperimental Treatment1 Intervention

As part of the monitoring needed for this study, participants will be enrolled for at least 6 months, as this will give enough data to understand how the participant's health changes associate with what is measured by the Apple watch. After this 6 month period, participants may choose to end their participation on the study, or continue if they wish.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apple Watch

2022

N/A

~600

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Deep Vein Thrombosis (DVT) are anticoagulants, which include medications like low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs) such as rivaroxaban and apixaban, and warfarin. These drugs work by inhibiting various factors in the blood coagulation pathway, thereby preventing the formation of new clots and the growth of existing ones. This is crucial for DVT patients as it reduces the risk of complications such as pulmonary embolism and post-thrombotic syndrome. Monitoring tools, like the Apple Watch, can play a significant role in early detection and management by tracking physiological changes that may indicate clot formation, thus allowing for timely medical intervention.

[News in Angiology and Hemostasis].A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective anticoagulation length with low molecular weight heparin in the treatment of cancer associated thrombosis (ALICAT): study protocol for a mixed-methods study.