Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Elective Abdominal Surgery

There is data confirming that simple tests of physical capability, such as the timed "get-up-and-go" test and the 6-minute walk test, correlate with surgical outcomes. It is reasonable to assume that preoperative telemonitoring, which allows for the tracking of more variables over a wider range of activities, could provide a significantly more accurate picture of a patient's physical fitness than a short one-time test performed in the clinic setting.

Almost half of the patients who are readmitted at Washington University are readmitted for less than 4 days. The readmitted patients usually present with sepsis, are treated with antibiotics and percutaneous drainage, and are discharged home relatively quickly. Earlier identification of these patients, prior to the development of sepsis, would reduce the risks to the patient and allow for outpatient management.

Study Overview

• Status: Terminated
• Conditions: Abdominal Surgery
• Intervention / Treatment: Other: Phone Call

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled to undergo elective abdominal surgery
• At least 18 years of age
• Able to understand and willing to sign an IRB-approved informed consent document

Exclusion Criteria:

• Doesn't have access to smartphone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phone Call; Patients will be provided with a Fitbit wristband & assistance to set up on smart phone; Preoperative baseline data (activity, sleep, heartrate) will be collected for at least 14 days until the day prior to surgery; The group will receive a phone call 7 days into their preoperative period to identify barriers, provide available resources, & encourage continuation of prehabilitation activities; The physician extender will talk with the patient to identify barriers to prehabilitation activities that the patient may have experienced during the first 7 days of activity tracking & provide recommendations & resources to overcome those barriers when possible. The physician extender will encourage the patient to continue prehabilitation activities until the day of operation to meet goals. Following surgery, we will analyze Fitbit data to determine if the intervention had an impact on the patient's prehabilitation activity with the non-intervened patient group used as a control	Other: Phone Call; -phone call 7 days (+/- 2 days) into preoperative period
No Intervention: No Phone Call; Eligible patients will be provided with a Fitbit wristband & assistance to set up on smart phone; Preoperative baseline data (activity, sleep, heartrate) will be collected for at least 14 days until the day prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the study intervention during the preoperative period to increase patients compliance with prehabilitation goals as measured by average steps per day		Baseline through 30 days after surgery discharge (approximately 45 days)
Patient compliance of telemonitoring with activity trackers as measured by percentage of time the patient is wearing the device properly	-The number of heart rate data points that are collected per day is used as a proxy for determining the amount of time the patient is wearing the device properly.	Baseline through 30 days after surgery discharge (approximately 45 days)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: The Foundation for Barnes-Jewish Hospital; BJC Innovative Lab
• Investigators: Principal Investigator: Chet Hammill, M.D., MCR, FACS, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 201810002

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