Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03776526
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2018-07-26
Brief Title:
Researching the Effects of Sleep on STep Count dUring the Postoperative Period
Sponsor:
Christopher Patterson
Organization:
McMaster University
Study Overview
Official Title:
Researching the Effects of Sleep on Step Count During the Postoperative Period Following Surgery for Hip Fracture
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REST-UP
Brief Summary:
Patients over the age of 65 who are admitted to the Juravinski Hospital for treatment of hip fractures will be invited to take part in the study An activity monitor a Fitbit Alta HR will be attached to the participant post-operatively to record quality of sleep and amount of activity for the duration of hospital stay The time spent in hospital and whether complications or confusion develops will also be recorded The aim is to determine whether poor sleep affects recovery after hip fracture surgery
Detailed Description:
The purpose of this study is to examine the influence of sleep duration and quality on post-operative mobility in older adults admitted to hospital with a hip fracture The hypothesis is that poor sleep will independently predict low post-operative mobility measured by number of steps Recent developments in activity monitor technology allow for the collection of reliable assessments of movement and sleep rhythm during surgical recovery
The Fitbit Alta HR activity monitor will be used for this study When the participant is awake and alert after surgery and informed consent has been obtained a study team member will fasten the Fitbit device on the wrist of the participants non-dominant hand Investigators will monitor sleep quality and daily steps taken for the duration of hospitalization with the option to discontinue if clinically required or requested by the patient or provider At the time of discharge the wearable biosensor will be reset and the information will be erased from its memory The wearable biosensors will be cleaned with disinfectant used for durable medical equipment
The study population will include patients aged 65 admitted with hip fracture to the orthopedic ward E2 at the Juravinski Hospital Descriptive data on patients admitted with hip fracture will be collected including age gender Charlson comorbidity index diagnosis of dementia pre-hospital living accommodation mobility aids level of pre-admission mobility using the functional independence measure FIM and number of beds per room Timing of surgery within 24 hours 48 hours or more than 48 hours after admission highest reported daily pain score and foley catheter use will also be collected from the medical record The use of sleep medications will be tracked each night during the study period The physiotherapy notes will be screened for information on total distance ambulated in meters and in-hospital mobility progression Post-operative complications such as Stroke Cardiac event Pneumonia Venous thromboembolism GI tract bleed Urinary tract infections Postoperative anemia Acute Kidney Injury and Pressure sores will be tracked from the medical record Investigators will also contact participants by phone after 30 days have elapsed since discharge to inquire about mortality FIM score and location of disposition
The primary outcome is the total number of steps taken by participants during each 24-hour period after surgery for hip fracture Mean daily steps will be calculated based on the number of days the activity monitor was worn Secondary outcomes will be delirium prevalence hospital length of stay post-operative complications 30-day post-discharge mortality mobility status FIM - locomotion subscale score and location of disposition The primary behavioural exposure is monitoring of sleep duration measured by total sleep time in minutes and quality number of awakenings per night Daytime naps will also be recorded
One of the key strengths of this study is that both the primary outcome and the key exposure are measured using a single device which improves the reliability and efficiency of data collection
The Fitbit Alta HR activity monitor will be used for this study When the participant is awake and alert after surgery and informed consent has been obtained a study team member will fasten the Fitbit device on the wrist of the participants non-dominant hand Investigators will monitor sleep quality and daily steps taken for the duration of hospitalization with the option to discontinue if clinically required or requested by the patient or provider At the time of discharge the wearable biosensor will be reset and the information will be erased from its memory The wearable biosensors will be cleaned with disinfectant used for durable medical equipment
The study population will include patients aged 65 admitted with hip fracture to the orthopedic ward E2 at the Juravinski Hospital Descriptive data on patients admitted with hip fracture will be collected including age gender Charlson comorbidity index diagnosis of dementia pre-hospital living accommodation mobility aids level of pre-admission mobility using the functional independence measure FIM and number of beds per room Timing of surgery within 24 hours 48 hours or more than 48 hours after admission highest reported daily pain score and foley catheter use will also be collected from the medical record The use of sleep medications will be tracked each night during the study period The physiotherapy notes will be screened for information on total distance ambulated in meters and in-hospital mobility progression Post-operative complications such as Stroke Cardiac event Pneumonia Venous thromboembolism GI tract bleed Urinary tract infections Postoperative anemia Acute Kidney Injury and Pressure sores will be tracked from the medical record Investigators will also contact participants by phone after 30 days have elapsed since discharge to inquire about mortality FIM score and location of disposition
The primary outcome is the total number of steps taken by participants during each 24-hour period after surgery for hip fracture Mean daily steps will be calculated based on the number of days the activity monitor was worn Secondary outcomes will be delirium prevalence hospital length of stay post-operative complications 30-day post-discharge mortality mobility status FIM - locomotion subscale score and location of disposition The primary behavioural exposure is monitoring of sleep duration measured by total sleep time in minutes and quality number of awakenings per night Daytime naps will also be recorded
One of the key strengths of this study is that both the primary outcome and the key exposure are measured using a single device which improves the reliability and efficiency of data collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None