Image

Remote Monitoring of Surgical Patients Through VALIDIC

Remote Monitoring of Surgical Patients Through VALIDIC

Non Recruiting
75 years and older
All
Phase N/A

Powered by AI

Overview

We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. We will use the information as guidance for improving activity in surgical patients at Duke. The activity tracker will be worn for the peri-operative period which starts at the time of the surgery/clinic visit and continues during the inpatient hospital stay and for 30 days following discharge. The vivosmart®HR is a commercially available device that is made of plastic and designed to be worn around the wrist. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. No discomfort or burden is expected from wearing the monitor, and patients will have continuous feedback on their daily activity.

Description

We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. We will use the information as guidance for improving activity in surgical patients at Duke. All ambulatory patients going through the POSH program currently receive individualized counseling on enhancing their activity levels. The data collected in this project will be used to help refine counseling and identify optimal time frames where exercise counseling is most beneficial. Our goal is to help with disease management, remote monitoring alerts, readmission prevention, care coordination and placement of required consults.

Aim1: Evaluate the feasibility of data capture, data integration into EPIC, and validate data flow Aim 2: Retrospective review of data to identify opportunities for alerts Aim 3: Improve physical function of older patients

This is a prospective remote patient monitoring study in the peri-operative and post-operative period to improve surgical outcomes. The peri-operative period starts at the time of the surgery/POSH clinic visit, continues during the inpatient hospital stay and for 30 days following discharge.

Patients undergoing elective abdominal surgery will be asked to use a wearable activity tracker, vivosmart®HR by Garmin, pre and post-operatively to help remotely monitor health metrics. Data collected through the Garmin device will be reviewed to assess compliance and improvement in activity. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. The metrics we plan to assess are the following:

Garmin data:

Steps, distance, calories, heart rate, 7 day resting average, floors climbed activity intensity, sleep cycles, inactive periods.

Surgery data:

Length of stay, Complications, Readmissions, Emergency Department visits

Patients may be called weekly to ensure compliance and ask any questions or report any issues with the activity tracker. All data will exist in MaestroCare and will be captured after the post-surgical period.

Eligibility

Inclusion Criteria:

  1. Over 75 yo
  2. HBP procedures, Colorectal procedures, Open VHRs
  3. No obvious cognitive deficits
  4. Should be able to walk with or without mobility aid
  5. Willingness to use smart phone in the study

Exclusion Criteria:

  1. non-ambulatory status,
  2. dementia, or
  3. a pending cardiac clearance requirement for surgery.

Study details
    Elective Abdominal Surgery

NCT05486962

Duke University

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.