Abdominal SurgeryNCT03706963
Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Elective Abdominal Surgery
A study testing Phone Call in people with Abdominal Surgery, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Phone Call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 10 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Doesn't have access to smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Phone Call
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone CallOther
-phone call 7 days (+/- 2 days) into preoperative period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the study intervention during the preoperative period to increase patients compliance with prehabilitation goals as measured by average steps per day
Measured: 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.
Measured: Baseline through 30 days after surgery discharge (approximately 45 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start15 Jan 2019
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Why it stopped: Intervention is no longer being used
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital, BJC Innovative Lab
- Responsible party
- Sponsor
- Investigators
- Chet Hammill, M.D., MCR, FACS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706963
- Sponsor's protocol ID
- 201810002
- Status last verified
- Dec 2022
- First submitted
- 11 Oct 2018
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Elective Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03706963
- Acronym / sponsor ID
- 201810002
- Conditions
- Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intervention is no longer being used
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital, BJC Innovative Lab
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone Call | Experimental | Other: 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Doesn't have access to smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone Call-phone call 7 days (+/- 2 days) into preoperative period | Other | Phone Call |
Primary outcome
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)
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.
Results and safety
The study was stopped early (reason given: Intervention is no longer being used). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chet Hammill, M.D., MCR, FACS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone Call in people with Abdominal Surgery, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Intervention is no longer being used). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.