Remote Monitoring of Surgical Patients Through VALIDIC

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.

Study Overview

• Status: Completed
• Conditions: Elective Abdominal Surgery
• Intervention / Treatment: Behavioral: Remote Patient Monitoring

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients undergoing elective abdominal surgery at Duke.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Remote Patient Monitoring; 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.

Behavioral: Remote Patient Monitoring; 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.; Other Names: vivosmart®HR; VALIDIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	proportion of those who were approached and eligible, and who agreed to participate (i.e., recruitment rates)	Enrollment
Completion Rate	proportion of those who completed the protocol (i.e., completion rate)	30 days post-operatively
Retention Rate	proportion who participated in all three settings (pre hospital, hospital, post hospital) (i.e., retention rate),	30 days post-operatively
Scale-Level Completion Rate	proportion who completed use of the activity trackers, and determine the reason for any missing data including lack of understanding, ability, or simple refusal (i.e., scale-level completion rate);	30 days post-operatively
Study Duration	documented duration of the protocol (i.e., feasibility);	45 days after last patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alert Timepoints	Retrospective review of data to identify opportunities for alerts: LOS, Complications, Readmissions, ED visits	30 days post-operatively
Physical Function	Improve physical function of older patients by evaluating: LOS, Complications, Readmissions, ED visits	30 days post-operatively

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Sandhya Lagoo-Deenadayalan, MD, PhD, Duke Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00110616

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