SurgeryNCT03711149
Activity Monitor Feedback and Interactive Tours to Improve Postoperative Ambulation
A study testing Activity monitor feedback loop in people with Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This is a randomized controlled trial that compares a system using activity monitors to provide real-time feedback on daily ambulation to patients undergoing major surgeries, paired with step-count-measured art tours of the surgical units, versus standard of care, on step count. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Activity monitor feedback loop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 30 Dec 2019
- 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
- Undergoing one of the 14 surgeries: Gynecological (Total Abdominal Hysterectomy, Gyn Ex Lap); Orthopedic (Total Hip Replacement, Total Knee Replacement); Minimally Invasive Surgery (Hiatal Hernia Repair/Fundoplication, Gastric Bypass, Gastric Sleeve); Colorectal Surgery (Lap/Robotic Colectomy, Ileocolic Resection, Open Colectomy); Thoracic (Lung Lobectomy); Urologic (Robotic Cystectomy, Radical Prostatectomy, Partial Nephrectomy).
- Able to provide informed consent
- Non-English speakers will be included with the use of short forms in the 7 available languages
- Must have access to an IOS or Android device
Who cannot join
- Unable to provide consent
- Not undergoing procedure of interest
- Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation)
- Use of walker, cane, or wheelchair at baseline
- Presence of physical limitations on walking (i.e. amputation)
- Usual place of residence is skilled nursing facility
- Cognitive inability to follow directions to maintain activity monitor in place
- Unable to place activity monitor on patient's wrist
Trial locations and contacts
1 site in 1 country.
Mayra L Lopez, MPH contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mayra L Lopez, MPH
About this study
Official title: Randomized Controlled Trial of Activity Monitor Feedback and Interactive Ambulation Tours to Improve Postoperative Ambulation and Efficiency Outcomes After Major Surgery
This is a randomized controlled trial that compares a system using activity monitors to provide real-time feedback on daily ambulation to patients undergoing major surgeries, paired with step-count-measured art tours of the surgical units, versus standard of care, on step count. The hypothesis is that the feedback system + art tours will encourage patients to ambulate more.
Read the detailed description
After major surgery, patients are encouraged to walk early and often, since early ambulation is linked with improved clinical and efficiency outcomes. This research study tests whether providing goal-directed feedback on daily ambulation to patients using activity monitors in combination with an app that provides step count-rated "art tours" of the surgical floors will increase the amount of steps taken after surgery. Upon enrollment, all patients will be assigned to either the control (no intervention) or experimental (activity monitor feedback + art tours) group, stratified by surgery type. This randomized controlled trial aims to determine if this feedback system/art tours approach improves: (1) daily step count, (2) length of stay, and (3) patient satisfaction compared with standard of care.
- Conditions
- Surgery
- Being tested
- Activity monitor feedback loop
- Keywords
- Ambulation, Length of stay, Patient Satisfaction, Activity Monitor, Digital Health
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity monitor feedback loopOther
The intervention arm will test if the feedback system (i.e., activity monitor, real-time feedback, and art tours) increases daily step count, decreases length of stay, and improves patient and provider communication, patient awareness of step count goals, and patient confidence in accomplishment of daily goals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intervention: Activity monitor feedback loop: (1) Subjects will receive activity monitor with feedback on daily step count from the in-room TV screen, and (2) access to the Art Tour application Receives: Other: Activity monitor feedback loop |
| Standard-of-care Arm | No intervention | Subjects in the control arm will receive a "blinded" activity monitor post-op (without feedback on step count) and the usual standard of care. Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods of observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Step Count
Daily step count will be captured with activity monitor
Measured: During hospitalization within approximately 1-2 weeks
Secondary outcomes (2)
Length of stay
Length of stay in intervention arm compared to control
Measured: Within approximately 1-2 weeks, Date patient was admitted through hospital discharge
Patient Satisfaction
Patient satisfaction measured using likert-scale rated items. Scale measures patient/physician communication, patient awareness of step goals, and patient confidence in accomplishment of daily goals. The following scale ranges will be used:
- Never, Once a day, Twice a day, Three times a day, More than three times a day
- Much lower, Lower, About the same, Higher, Much higher
- Not at all, Slightly, Moderately, Very, Extremely
Positive answer in likert-scales indicate higher patient/physician communication, patient awareness, and patient confidence in accomplishing daily step goals.
Measured: Within approximately 1-2 weeks, Day patient is discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start5 Dec 2018
- Primary completion22 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial will involve two arms: (1) and intervention arm consisting of activity monitor feedback loop and art tours and (2) control group consisting of standard of care.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy J. Daskivich, Cedars-Sinai Medical Center
- Investigators
- Timothy Daskivich, MD, MSHPM, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711149
- Sponsor's protocol ID
- Pro00051802
- Status last verified
- Mar 2019
- First submitted
- 11 Oct 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Activity Monitor Feedback and Interactive Ambulation Tours to Improve Postoperative Ambulation and Efficiency Outcomes After Major Surgery
- ClinicalTrials.gov ID
- NCT03711149
- Acronym / sponsor ID
- Pro00051802
- Conditions
- Surgery
- Keywords
- Ambulation, Length of stay, Patient Satisfaction, Activity Monitor, Digital Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 22 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 18 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.
This is a randomized controlled trial that compares a system using activity monitors to provide real-time feedback on daily ambulation to patients undergoing major surgeries, paired with step-count-measured art tours of the surgical units, versus standard of care, on step count. The hypothesis is that the feedback system + art tours will encourage patients to ambulate more.
Detailed description
After major surgery, patients are encouraged to walk early and often, since early ambulation is linked with improved clinical and efficiency outcomes. This research study tests whether providing goal-directed feedback on daily ambulation to patients using activity monitors in combination with an app that provides step count-rated "art tours" of the surgical floors will increase the amount of steps taken after surgery. Upon enrollment, all patients will be assigned to either the control (no intervention) or experimental (activity monitor feedback + art tours) group, stratified by surgery type. This randomized controlled trial aims to determine if this feedback system/art tours approach improves: (1) daily step count, (2) length of stay, and (3) patient satisfaction compared with standard of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled trial will involve two arms: (1) and intervention arm consisting of activity monitor feedback loop and art tours and (2) control group consisting of standard of care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Activity monitor feedback loopIntervention: Activity monitor feedback loop: (1) Subjects will receive activity monitor with feedback on daily step count from the in-room TV screen, and (2) access to the Art Tour application |
| Standard-of-care Arm | No intervention | –Subjects in the control arm will receive a "blinded" activity monitor post-op (without feedback on step count) and the usual standard of care. Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods of observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing one of the 14 surgeries: Gynecological (Total Abdominal Hysterectomy, Gyn Ex Lap); Orthopedic (Total Hip Replacement, Total Knee Replacement); Minimally Invasive Surgery (Hiatal Hernia Repair/Fundoplication, Gastric Bypass, Gastric Sleeve); Colorectal Surgery (Lap/Robotic Colectomy, Ileocolic Resection, Open Colectomy); Thoracic (Lung Lobectomy); Urologic (Robotic Cystectomy, Radical Prostatectomy, Partial Nephrectomy).
- Able to provide informed consent
- Non-English speakers will be included with the use of short forms in the 7 available languages
- Must have access to an IOS or Android device
Key exclusion criteria (8 listed)
- Unable to provide consent
- Not undergoing procedure of interest
- Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation)
- Use of walker, cane, or wheelchair at baseline
- Presence of physical limitations on walking (i.e. amputation)
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 |
|---|---|---|
| Activity monitor feedback loopThe intervention arm will test if the feedback system (i.e., activity monitor, real-time feedback, and art tours) increases daily step count, decreases length of stay, and improves patient and provider communication, patient awareness of step count goals, and patient confidence in accomplishment of daily goals. | Other | Intervention Arm |
Primary outcome
Daily Step Count
Time frame: During hospitalization within approximately 1-2 weeks
Daily step count will be captured with activity monitor
2 secondary outcomes
Length of stay
Time frame: Within approximately 1-2 weeks, Date patient was admitted through hospital discharge
Patient Satisfaction
Time frame: Within approximately 1-2 weeks, Day patient is discharged from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
Mayra L Lopez, MPH contact
Timothy Daskivich, MD, MSHPM principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity monitor feedback loop in people with Surgery, run by Cedars-Sinai Medical Center 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy Daskivich, MD, MSHPM ((310) 423-4700, timothy.daskivich@csmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Step Count (time frame: During hospitalization within approximately 1-2 weeks). 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 29 Mar 2019.