Using Wearable Device to Improve Quality of Palliative Care
NCT ID: NCT05054907
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2021-09-23
2023-04-30
Brief Summary
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Detailed Description
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This is a single-arm observational study using wearable devices and smartphones in terminal cancer patients. Investigators planned to enroll 75 patients who receive palliative care. After obtaining consent from the patients or their legally authorized surrogate decision-makers, a baseline assessment will be conducted, with a guide to use wearable devices and phone apps.
Investigators will keep regular follow-up for 52 weeks or until the participants' death. Assessment will be conducted every week, face-to-face or by telephone contact. A routine assessment includes symptoms and functionality in the past week, and vital signs and facial photograph will be recorded if possible. Physical data measured from wearable devices would be recorded continuously. The emergent medical needs of patient, including emergency department visit, unplanned admission and death of participants will be recorded if happen.
The primary outcome is the predictive performance (sensitivity and specificity) of the machine-learning model using wearable device data and symptoms assessment. The secondary outcomes are symptoms, including pain, dyspnea, diarrhea, constipation, nausea, vomiting, insomnia, depression, anxiety and fatigue. Users' opinion and comment to using experience will also be recorded.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Wearable devices + Smartphone
The only arm in the study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis: cancer in terminal stage.
Exclusion Criteria
20 Years
105 Years
ALL
No
Sponsors
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National Taiwan University
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jaw-Shiun Tsai, MDPHD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
National Taiwan University, Cancer Center
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Pavic M, Klaas V, Theile G, Kraft J, Troster G, Blum D, Guckenberger M. Mobile Health Technologies for Continuous Monitoring of Cancer Patients in Palliative Care Aiming to Predict Health Status Deterioration: A Feasibility Study. J Palliat Med. 2020 May;23(5):678-685. doi: 10.1089/jpm.2019.0342. Epub 2019 Dec 23.
Liu JH, Shih CY, Huang HL, Peng JK, Cheng SY, Tsai JS, Lai F. Evaluating the Potential of Machine Learning and Wearable Devices in End-of-Life Care in Predicting 7-Day Death Events Among Patients With Terminal Cancer: Cohort Study. J Med Internet Res. 2023 Aug 18;25:e47366. doi: 10.2196/47366.
Other Identifiers
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202105097RIND
Identifier Type: -
Identifier Source: org_study_id
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