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Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Pancreatic Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706963
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Pancreas Disease Other: Phone Call Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Pancreatic Resection
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Phone Call
  • Patients will be provided with a Fitbit Charge HR & assistance to set up on smart phone
  • Preoperative baseline data (activity, sleep, heartrate) will be collected for 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 Charge HR & assistance to set up on smart phone
  • Preoperative baseline data (activity, sleep, heartrate) will be collected for 14 days until the day prior to surgery



Primary Outcome Measures :
  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 [ Time Frame: Baseline through 30 days after surgery discharge (approximately 45 days) ]
    -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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo pancreatic resection
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706963


Contacts
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Contact: Chet Hammill, M.D., MCR, FACS 314-273-1809 hammillc@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Chet Hammill, M.D., MCR, FACS    314-273-1809    hammillc@wustl.edu   
Principal Investigator: Chet Hammill, M.D., MCR, FACS         
Sub-Investigator: Ryan Fields, M.D., FACS         
Sub-Investigator: William Hawkins, M.D., FACS         
Sub-Investigator: Dominic Sanford, M.D., FACS         
Sub-Investigator: Steven Strasberg, M.D., FACS, MPHS         
Sub-Investigator: Esther Lu, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Chet Hammill, M.D., MCR, FACS Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03706963    
Other Study ID Numbers: 201810002
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases