NCT04883879

Brief Summary

The purpose of this study is to develop a novel deep-learning-based survival prediction model employing patient activity data recorded by a wearable device.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

April 28, 2021

Last Update Submit

May 6, 2021

Conditions

Keywords

Wearable DeviceActigraphy DeviceSurvival PredictionDeep LearningArtificial IntelligenceHospice CarePalliative Care

Outcome Measures

Primary Outcomes (1)

  • Specificity and Sensitivity of using Artificial Intelligence based models for prediction of Clinical Outcomes of End-stage Cancer Patients using actigraphy data

    The primary outcome of the study will be to evaluate whether the analysis of the movement data captured using actigraphy device can help to predict clinical outcomes either deceased or discharged alive from hospital, with a high specificity and sensitivity, using Artificial Intelligence based prediction modelling.

    From date of admission to hospice ward until the date of first documented discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 20 years or older who were admitted to the hospice care unit at Taipei Medical University Hospital with at least one diagnosis of end-stage solid tumor diseases.

You may qualify if:

  • Participants aged 20 years or older admitted to the hospice care unit at Taipei Medical University Hospital
  • Participants diagnosed with at least one end-stage solid tumor diseases
  • Participants consented to receive hospice care

You may not qualify if:

  • Participants aged below 20 years of age
  • Participants diagnosed with leukemia or carcinoma of unknown primary
  • Participants with evident signs of approaching death upon admission
  • Participants with no vital signs upon admission
  • Participants who continued to receive aggressive treatment despite admission to the hospice care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, TW - Taiwan, 110, Taiwan

RECRUITING

Related Publications (1)

  • Yang TY, Kuo PY, Huang Y, Lin HW, Malwade S, Lu LS, Tsai LW, Syed-Abdul S, Sun CW, Chiou JF. Deep-Learning Approach to Predict Survival Outcomes Using Wearable Actigraphy Device Among End-Stage Cancer Patients. Front Public Health. 2021 Dec 9;9:730150. doi: 10.3389/fpubh.2021.730150. eCollection 2021.

Study Officials

  • Shabbir Syed-Abdul, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shabbir Syed-Abdul, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 12, 2021

Study Start

December 11, 2019

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Locations