Remote Monitoring of Surgical Patients Through VALIDIC

NCT05486962 | Completed

• 1 other identifier: Pro00110616
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elective Abdominal Surgery

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Alert Timepoints

  30 days post-operatively

• Physical Function

  30 days post-operatively

Study Arms (1)

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

Interventions

Remote Patient Monitoring BEHAVIORAL

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.

Also known as: vivosmart®HR, VALIDIC

Remote Patient Monitoring

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients undergoing elective abdominal surgery at Duke.

You may qualify if:

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

You may not qualify if:

• non-ambulatory status,
• dementia, or
• a pending cardiac clearance requirement for surgery.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Remote Patient Monitoring

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sandhya Lagoo-Deenadayalan, MD, PhD

  Duke Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: November 2, 2022
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)