Elective Abdominal SurgeryNCT05486962
Remote Monitoring of Surgical Patients Through VALIDIC
An observational study of Elective Abdominal Surgery, run by Duke University at 1 site in United States.
Trial summary
We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elective Abdominal Surgery
- What is being tested?
- Remote Patient Monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 9 Feb 2024
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients undergoing elective abdominal surgery at Duke.
Who may be able to join
- Over 75 yo
- HBP procedures, Colorectal procedures, Open VHRs
- No obvious cognitive deficits
- Should be able to walk with or without mobility aid
- Willingness to use smart phone in the study
Who cannot join
- non-ambulatory status,
- dementia, or
- a pending cardiac clearance requirement for surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. We will use the information as guidance for improving activity in surgical patients at Duke. The activity tracker will be worn for the peri-operative period which starts at the time of the surgery/clinic visit and continues during the inpatient hospital stay and for 30 days following discharge. The vivosmart®HR is a commercially available device that is made of plastic and designed to be worn around the wrist. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. No discomfort or burden is expected from wearing the monitor, and patients will have continuous feedback on their daily activity.
Read the detailed description
We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. We will use the information as guidance for improving activity in surgical patients at Duke. All ambulatory patients going through the POSH program currently receive individualized counseling on enhancing their activity levels. The data collected in this project will be used to help refine counseling and identify optimal time frames where exercise counseling is most beneficial. Our goal is to help with disease management, remote monitoring alerts, readmission prevention, care coordination and placement of required consults.
Aim1: Evaluate the feasibility of data capture, data integration into EPIC, and validate data flow Aim 2: Retrospective review of data to identify opportunities for alerts Aim 3: Improve physical function of older patients
This is a prospective remote patient monitoring study in the peri-operative and post-operative period to improve surgical outcomes. The peri-operative period starts at the time of the surgery/POSH clinic visit, continues during the inpatient hospital stay and for 30 days following discharge.
Patients undergoing elective abdominal surgery will be asked to use a wearable activity tracker, vivosmart®HR by Garmin, pre and post-operatively to help remotely monitor health metrics. Data collected through the Garmin device will be reviewed to assess compliance and improvement in activity. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. The metrics we plan to assess are the following:
Garmin data:
Steps, distance, calories, heart rate, 7 day resting average, floors climbed activity intensity, sleep cycles, inactive periods.
Surgery data:
Length of stay, Complications, Readmissions, Emergency Department visits
Patients may be called weekly to ensure compliance and ask any questions or report any issues with the activity tracker. All data will exist in MaestroCare and will be captured after the post-surgical period.
- Conditions
- Elective Abdominal Surgery
- Being tested
- Remote Patient Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient MonitoringBehavioural
Also called vivosmart®HR, VALIDIC
Patients undergoing elective abdominal surgery will be asked to use a wearable activity tracker, vivosmart®HR by Garmin, pre and post-operatively to help remotely monitor health metrics. Data collected through the Garmin device will be reviewed to assess compliance and improvement in activity. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery.
| Study group | Role | What they receive |
|---|---|---|
| Remote Patient Monitoring | Patients undergoing elective abdominal surgery will be asked to use a wearable activity tracker, vivosmart®HR by Garmin, pre and post-operatively to help remotely monitor health metrics. Data collected through the Garmin device will be reviewed to assess compliance and improvement in activity. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. Receives: Behavioral: Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
proportion of those who were approached and eligible, and who agreed to participate (i.e., recruitment rates)
Measured: Enrollment
Completion Rate
proportion of those who completed the protocol (i.e., completion rate)
Measured: 30 days post-operatively
Retention Rate
proportion who participated in all three settings (pre hospital, hospital, post hospital) (i.e., retention rate),
Measured: 30 days post-operatively
Scale-Level Completion Rate
proportion who completed use of the activity trackers, and determine the reason for any missing data including lack of understanding, ability, or simple refusal (i.e., scale-level completion rate);
Measured: 30 days post-operatively
Study Duration
documented duration of the protocol (i.e., feasibility);
Measured: 45 days after last patient enrollment
Secondary outcomes (2)
Alert Timepoints
Retrospective review of data to identify opportunities for alerts:
LOS, Complications, Readmissions, ED visits
Measured: 30 days post-operatively
Physical Function
Improve physical function of older patients by evaluating:
LOS, Complications, Readmissions, ED visits
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start2 Nov 2022
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandhya Lagoo-Deenadayalan, MD, PhD, Principal investigator, Duke Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486962
- Sponsor's protocol ID
- Pro00110616
- Status last verified
- Feb 2024
- First submitted
- 2 Aug 2022
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Surgical Patients Through VALIDIC
- ClinicalTrials.gov ID
- NCT05486962
- Acronym / sponsor ID
- Pro00110616
- Conditions
- Elective Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 4 Aug 2022 (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.
We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. We will use the information as guidance for improving activity in surgical patients at Duke. The activity tracker will be worn for the peri-operative period which starts at the time of the surgery/clinic visit and continues during the inpatient hospital stay and for 30 days following discharge. The vivosmart®HR is a commercially available device that is made of plastic and designed to be worn around the wrist. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. No discomfort or burden is expected from wearing the monitor, and patients will have continuous feedback on their daily activity.
Detailed description
We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. We will use the information as guidance for improving activity in surgical patients at Duke. All ambulatory patients going through the POSH program currently receive individualized counseling on enhancing their activity levels. The data collected in this project will be used to help refine counseling and identify optimal time frames where exercise counseling is most beneficial. Our goal is to help with disease management, remote monitoring alerts, readmission prevention, care coordination and placement of required consults.
Aim1: Evaluate the feasibility of data capture, data integration into EPIC, and validate data flow Aim 2: Retrospective review of data to identify opportunities for alerts Aim 3: Improve physical function of older patients
This is a prospective remote patient monitoring study in the peri-operative and post-operative period to improve surgical outcomes. The peri-operative period starts at the time of the surgery/POSH clinic visit, continues during the inpatient hospital stay and for 30 days following discharge.
Patients undergoing elective abdominal surgery will be asked to use a wearable activity tracker, vivosmart®HR by Garmin, pre and post-operatively to help remotely monitor health metrics. Data collected through the Garmin device will be reviewed to assess compliance and improvement in activity. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. The metrics we plan to assess are the following:
Garmin data:
Steps, distance, calories, heart rate, 7 day resting average, floors climbed activity intensity, sleep cycles, inactive periods.
Surgery data:
Length of stay, Complications, Readmissions, Emergency Department visits
Patients may be called weekly to ensure compliance and ask any questions or report any issues with the activity tracker. All data will exist in MaestroCare and will be captured after the post-surgical period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Patient Monitoring | – | Behavioral: Remote Patient MonitoringPatients undergoing elective abdominal surgery will be asked to use a wearable activity tracker, vivosmart®HR by Garmin, pre and post-operatively to help remotely monitor health metrics. Data collected through the Garmin device will be reviewed to assess compliance and improvement in activity. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients undergoing elective abdominal surgery at Duke.
Key inclusion criteria (5 listed)
- Over 75 yo
- HBP procedures, Colorectal procedures, Open VHRs
- No obvious cognitive deficits
- Should be able to walk with or without mobility aid
- Willingness to use smart phone in the study
Key exclusion criteria (3 listed)
- non-ambulatory status,
- dementia, or
- a pending cardiac clearance requirement for surgery.
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 |
|---|---|---|
| Remote Patient MonitoringAlso: vivosmart®HR, VALIDICPatients undergoing elective abdominal surgery will be asked to use a wearable activity tracker, vivosmart®HR by Garmin, pre and post-operatively to help remotely monitor health metrics. Data collected through the Garmin device will be reviewed to assess compliance and improvement in activity. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. | Behavioural | Remote Patient Monitoring |
Primary outcome
Recruitment Rate
Time frame: Enrollment
proportion of those who were approached and eligible, and who agreed to participate (i.e., recruitment rates)
Completion Rate
Time frame: 30 days post-operatively
proportion of those who completed the protocol (i.e., completion rate)
Retention Rate
Time frame: 30 days post-operatively
proportion who participated in all three settings (pre hospital, hospital, post hospital) (i.e., retention rate),
Scale-Level Completion Rate
Time frame: 30 days post-operatively
proportion who completed use of the activity trackers, and determine the reason for any missing data including lack of understanding, ability, or simple refusal (i.e., scale-level completion rate);
Study Duration
Time frame: 45 days after last patient enrollment
documented duration of the protocol (i.e., feasibility);
2 secondary outcomes
Alert Timepoints
Time frame: 30 days post-operatively
Physical Function
Time frame: 30 days post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
Sandhya Lagoo-Deenadayalan, MD, PhD principal investigator
Duke Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Abdominal Surgery, run by Duke University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment Rate (time frame: Enrollment). The study lists 5 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 28 Feb 2024.