Using Pedometers for the Assessment and Enhancement of Mobility in Gynaecological and Oncological Patients Following Surgery.
1 other identifier
interventional
150
1 country
1
Brief Summary
This is a prospective cohort study, planned to study the effects of pedometers (digital step counters) on patient mobility following gynecology and gynecology oncology surgeries. The investigators plan to study the effect of personalized repeated feedback approach based on pedometer results in patients following gynecology and gynecology oncology surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable surgery
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJanuary 15, 2021
May 1, 2020
2 years
January 9, 2021
January 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of steps per day during the hospitalization period
umber of steps taken by patient as recirded by pedometer
Up to 1 week
Secondary Outcomes (4)
Number of participants with complication following surgery
Up to 1 week
Number of analgesic doses
Up to 1 week
Length of hospitalization
Up to 4 week
Number of thromboembolic events
Up to 4 week
Study Arms (2)
Experimental: Feedback
EXPERIMENTALPatients in this arm will wear a pedometer following gynecology and gynecology oncology surgeries until discharge. During this period, they will recieve feedback regrding the number of steps taken by them at the end of each day
No Intervention: Control
NO INTERVENTIONPatients in this arm will wear a pedometer following gynecology and gynecology oncology surgeries until discharge. During this period, they will recieve no feedback regrding the number of steps taken by them.
Interventions
Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
Eligibility Criteria
You may qualify if:
- Patients following gynecology and gynecology oncology surgery Consent to participation No medical recommendation for bed rest and limited mobility
You may not qualify if:
- Refusal to participate Medical recommendation to limit mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Medical Center
Tel Aviv, 64239, Israel
Related Publications (1)
Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.
PMID: 32459426BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2021
First Posted
January 15, 2021
Study Start
May 1, 2020
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
January 15, 2021
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share