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

NCT03706963 | Terminated

• 1 other identifier: 201810002
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Surgery

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Phone Call

EXPERIMENTAL

* 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

No Phone Call

NO INTERVENTION

* 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

Interventions

Phone Call OTHER

-phone call 7 days (+/- 2 days) into preoperative period

Phone Call

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Doesn't have access to smartphone

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator
• BJC Innovative Lab: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Study Officials

• Chet Hammill, M.D., MCR, FACS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: January 15, 2019
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)