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TerminatedNCT03706963Updated Dec 12, 2022

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

An interventional study of Phone Call in Abdominal Surgery, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-12.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care

Why this study was terminated
Intervention is no longer being used
Phase
Not applicable
Study type
Interventional
Enrollment
169
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Abdominal Surgery
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In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Doesn't have access to smartphone
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
169 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherPhone Call

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

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What researchers measure

Primary outcomes

  1. Effectiveness of the study intervention during the preoperative period to increase patients compliance with prehabilitation goals as measured by average steps per day

    Time frame: Baseline through 30 days after surgery discharge (approximately 45 days)

  2. 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.

    Time frame: Baseline through 30 days after surgery discharge (approximately 45 days)

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Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03706963
Lead sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital, BJC Innovative Lab
Responsible party
Sponsor
First posted
Oct 16, 2018
Start date
Jan 15, 2019
Primary completion
Jul 10, 2022
Completion
Jul 10, 2022
Last update
Dec 12, 2022

Study contacts

Chet Hammill, M.D., MCR, FACS
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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