Glioblastoma Remote Monitoring and Care - Research Protocol
The purpose of this research is to learn more about how what the Apple watch measures, in terms of walking data, heart rate, breathing rate, and sleep habits, relates to how participants feel. During the course of the treatment, the symptoms participants experience change, and whether the Apple watch can detect these changes. Ultimately, this knowledge is being used to design proactive tools and signatures that can predict complications or symptom changes before they happen.
Conditions:
🦠 Glioblastoma 🦠 Venous Thromboembolism 🦠 Seizures
🗓️ Study Start (Actual) 30 April 2024
🗓️ Primary Completion (Estimated) 1 January 2025
✅ Study Completion (Estimated) 1 January 2027
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * newly-diagnosed or recurrent glioblastoma undergoing treatment or active surveillance
    • * at least 18 years of age at the time of study enrolment
    • * Karnofsky Performance Status (KPS) ≥ 70% at time of study enrolment
    • * able to comprehend informed consent form and provide informed consent
    • * access to patient or caregiver's own Apple iPhone to interface with watch application for documentation of symptoms

    Exclusion Criteria:

    • * under 18 years of age at the time of study enrolment
    • * inability to give informed consent due to aphasia or other language barrier
    • * tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed or other skin conditions preventing adequate sensor function
    • * inability to tolerate Apple Watch for at least 12 hours per day on at least 50% of days in a four-week period
    • * no access to patient or caregiver Apple iPhone to document symptoms
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 November 2023
  • First Submitted that Met QC Criteria 8 November 2023
  • First Posted 13 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 May 2024
  • Last Update Posted 10 May 2024
  • Last Verified May 2024