- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06638060
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC
March 10, 2026 updated by: Medtronic - MITG
To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - 1) hospital (Acute Care for Elderly Unit) and 2) at-home .
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elise Huisman
- Phone Number: +1 236-308-4876
- Email: elise.huisman@medtronic.com
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Recruiting
- St. Paul'sHospital
-
Contact:
- Janet Kow, MD
- Email: jkow@providencehealth.bc.ca
-
Principal Investigator:
- Janet Kow, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The Acute Care for Elderly Unit at SPH for 40 inpatients over the age of 65.
Description
Inclusion Criteria:
- Inpatients on the Acute care of the Elderly ward.
Exclusion Criteria:
- Lack of capacity to consent to the study including moderate-severe dementia or delirium
- Unable to use (or does not have a caregiver who can help put on) study monitoring device at home
- Unable to complete (or does not have a caregiver who can help complete) study questionnaires by electronic (mobile, tablet, or computer), paper, nor phone
- Patient with known allergic reactions to any part material of the device
- People under 40kg
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collect patient and clinicians' feedback about the CCPC Platform
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed via an assessment of the quantitative data on how long and how often patients use this monitoring and what were the reasons that patients took the monitors on and off.
|
From enrollment to the end of follow up at 10 days
|
|
Collect patient and clinicians' feedback about the CCPC Platform
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed via an assessment of the Usability Questionnaire.
|
From enrollment to the end of follow up at 10 days
|
|
Collect patient and clinicians' feedback about the CCPC Platform
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed by an evaluation for potential harm, e.g.
anxiety questionnaire and any patient-reported adverse events.
|
From enrollment to the end of follow up at 10 days
|
|
Confirm the technical goals of the CCPC platform are met.
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed by ensuring clinician workflow is met, via feedback sessions (e.g.
conversations, questionnaires).
|
From enrollment to the end of follow up at 10 days
|
|
Confirm the technical goals of the CCPC platform are met.
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed via an assessment of the data flow: does the correct patient data reach the clinicians at the right time?
|
From enrollment to the end of follow up at 10 days
|
|
Confirm the technical goals of the CCPC platform are met.
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed by determining if the CCPC platform provided a holistic view of each patient with vitals, medication, labs and other collected data.
|
From enrollment to the end of follow up at 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
March 13, 2025
Primary Completion (Estimated)
June 21, 2026
Study Completion (Estimated)
June 21, 2026
Study Registration Dates
First Submitted
September 16, 2024
First Submitted That Met QC Criteria
October 9, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- H24-00744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.