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

NCT ID: NCT03706963

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2022-07-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Phone Call

Intervention Type: OTHER

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phone Call

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Foundation for Barnes-Jewish Hospital

OTHER

Sponsor Role: collaborator

BJC Innovative Lab

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chet Hammill, M.D., MCR, FACS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201810002

Identifier Type: -

Identifier Source: org_study_id