RECRUITING

Pedometer Coaching to Promote Postoperative Ambulation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized controlled trial is to evaluate whether remote pedometer follow-up and virtual coaching can improve ambulation after major abdominopelvic surgery, and how this affects key postoperative outcomes. The main questions it aims to answer are: * Does pedometer-guided ambulation coaching increases ambulation after surgery? * Does pedometer-guided coaching improve satisfaction, quality of recovery, while reducing postoperative complications? Participants will be asked to install a pedometer app for the purpose of data sharing. Study personnel will compare pedometer follow-up plus text message coaching (intervention) with pedometer follow-up only (control) to investigate whether coaching improves adherence to the postoperative ambulation recommendation, and whether this leads to improvement of the secondary outcomes.

Official Title

A Randomized, Controlled Trial to Evaluate if Pedometer-Guided Coaching Can Promote Postoperative Ambulation After Abdominopelvic Surgeries

Quick Facts

Study Start:2023-01-31
Study Completion:2024-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06259591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult subjects ≥18 years at screening
  2. * Subjects undergoing major abdominopelvic surgery under general anesthesia, expected to last more than 3 hours from induction of anesthesia to anesthesia stop time.
  3. * Able to understand the study procedures and voluntarily provide study informed consent
  4. * Agree to be followed up for the duration of the study period
  5. * Has access to a smart phone with app compatibility
  6. * Planned inpatient stay for 1 night or more
  1. * Subjects undergoing liver surgery or upper gastrointestinal surgery
  2. * Refusal to install the app/ deleted app before end of the monitor period
  3. * Subjects who are unable to walk at baseline
  4. * Medical contraindications for unrestricted ambulation
  5. * Patients with spinal or lower limb pathology, chronic or poorly controlled pain potentially preventing full postoperative ambulation
  6. * Neurological impairment precluding unrestricted ambulation Cognitive impairment precluding consent or follow up study activities
  7. * BMI \>40
  8. * Patients who require any mobility aid at baseline
  9. * Subjects discharged to a rehab facility or never discharged from the hospital alive
  10. * Hospital length of stay \> 1 week
  11. * Patient not cleared by physical therapy for unrestricted ambulation on discharge

Contacts and Locations

Study Contact

Alexa Christophides, MHA
CONTACT
6314442939
alexa.christophides@stonybrookmedicine.edu
Zhaosheng Jin, MBBS
CONTACT
6318067909
zhaosheng.jin@stonybrookmedicine.edu

Principal Investigator

Sergio D Bergese, MD, FASA
PRINCIPAL_INVESTIGATOR
Stony Brook Medicine

Study Locations (Sites)

Stony Brook University Hospital
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Stony Brook University

  • Sergio D Bergese, MD, FASA, PRINCIPAL_INVESTIGATOR, Stony Brook Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-31
Study Completion Date2024-08

Study Record Updates

Study Start Date2023-01-31
Study Completion Date2024-08

Terms related to this study

Keywords Provided by Researchers

  • Wearable Electronic Devices
  • Ambulation

Additional Relevant MeSH Terms

  • Postoperative Outcomes