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

Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03706963
• Other study ID #: 201810002
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: July 10, 2022

Study information

• Verified date: December 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 169
• Est. completion date: July 10, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery

Intervention

Other:
• Phone Call
-phone call 7 days (+/- 2 days) into preoperative period

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	BJC Innovative Lab, The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)

External Links

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