<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03776526</url>
  </required_header>
  <id_info>
    <org_study_id>REST-UP</org_study_id>
    <nct_id>NCT03776526</nct_id>
  </id_info>
  <brief_title>Researching the Effects of Sleep on STep Count dUring the Postoperative Period</brief_title>
  <acronym>REST-UP</acronym>
  <official_title>Researching the Effects of Sleep on Step Count During the Postoperative Period Following Surgery for Hip Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christopher Patterson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients over the age of 65 who are admitted to the Juravinski Hospital for treatment of hip&#xD;
      fractures will be invited to take part in the study. An activity monitor (a Fitbit® Alta HR)&#xD;
      will be attached to the participant post-operatively, to record quality of sleep and amount&#xD;
      of activity for the duration of hospital stay. The time spent in hospital and whether&#xD;
      complications or confusion develops will also be recorded. The aim is to determine whether&#xD;
      poor sleep affects recovery after hip fracture surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the influence of sleep duration and quality on&#xD;
      post-operative mobility in older adults admitted to hospital with a hip fracture. The&#xD;
      hypothesis is that poor sleep will independently predict low post-operative mobility&#xD;
      (measured by number of steps). Recent developments in activity monitor technology allow for&#xD;
      the collection of reliable assessments of movement and sleep rhythm during surgical recovery.&#xD;
&#xD;
      The Fitbit® Alta HR activity monitor will be used for this study. When the participant is&#xD;
      awake and alert after surgery and informed consent has been obtained, a study team member&#xD;
      will fasten the Fitbit® device on the wrist of the participants' non-dominant hand.&#xD;
      Investigators will monitor sleep quality and daily steps taken for the duration of&#xD;
      hospitalization, with the option to discontinue if clinically required or requested by the&#xD;
      patient or provider. At the time of discharge, the wearable biosensor will be reset and the&#xD;
      information will be erased from its memory. The wearable biosensors will be cleaned with&#xD;
      disinfectant used for durable medical equipment.&#xD;
&#xD;
      The study population will include patients aged 65+ admitted with hip fracture to the&#xD;
      orthopedic ward (E2) at the Juravinski Hospital. Descriptive data on patients admitted with&#xD;
      hip fracture will be collected including age, gender, Charlson comorbidity index, diagnosis&#xD;
      of dementia, pre-hospital living accommodation, mobility aids, level of pre-admission&#xD;
      mobility using the functional independence measure (FIM), and number of beds per room. Timing&#xD;
      of surgery (within 24 hours, 48 hours, or more than 48 hours) after admission, highest&#xD;
      reported daily pain score and foley catheter use will also be collected from the medical&#xD;
      record. The use of sleep medications will be tracked each night during the study period. The&#xD;
      physiotherapy notes will be screened for information on total distance ambulated in meters&#xD;
      and in-hospital mobility progression. Post-operative complications such as Stroke, Cardiac&#xD;
      event, Pneumonia, Venous thromboembolism, GI tract bleed, Urinary tract infections,&#xD;
      Postoperative anemia, Acute Kidney Injury, and Pressure sores will be tracked from the&#xD;
      medical record. Investigators will also contact participants by phone after 30 days have&#xD;
      elapsed since discharge to inquire about mortality, FIM score and location of disposition.&#xD;
&#xD;
      The primary outcome is the total number of steps taken by participants during each 24-hour&#xD;
      period after surgery for hip fracture. Mean daily steps will be calculated based on the&#xD;
      number of days the activity monitor was worn. Secondary outcomes will be delirium prevalence,&#xD;
      hospital length of stay, post-operative complications, 30-day post-discharge mortality,&#xD;
      mobility status (FIM - locomotion subscale score), and location of disposition. The primary&#xD;
      behavioural exposure is monitoring of sleep duration (measured by total sleep time in&#xD;
      minutes) and quality (number of awakenings per night). Daytime naps will also be recorded.&#xD;
&#xD;
      One of the key strengths of this study is that both the primary outcome and the key exposure&#xD;
      are measured using a single device, which improves the reliability and efficiency of data&#xD;
      collection&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of steps per 24-hour day taken by patients during hospital admission after hip fracture repair.</measure>
    <time_frame>Through study completion, on average 1 week</time_frame>
    <description>Mean daily step count as measured by Fitbit®</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delirium rate (incidence)</measure>
    <time_frame>Through study completion, on average 1 week</time_frame>
    <description>Delirium assessed by confusion assessment method (CAM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>Through study completion, on average 1 week</time_frame>
    <description>Days from admission until discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>Through study completion, on average 1 week</time_frame>
    <description>Stroke, Cardiac event, Pneumonia, Venous thromboembolism, GI tract bleed, Urinary tract infections, Postoperative anemia, Acute Kidney Injury, and Pressure sores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day post-discharge mortality</measure>
    <time_frame>30 days post discharge</time_frame>
    <description>Death within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day mobility status</measure>
    <time_frame>30 days post discharge</time_frame>
    <description>Functional Independence Measure - locomotion subscale score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Location of disposition</measure>
    <time_frame>Through study completion, on average 1 week</time_frame>
    <description>community independent, community with home care, community with family support, inpatient rehabilitation, convalescent care, long term care, acute care hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Location of disposition at 30 days</measure>
    <time_frame>30 days post discharge</time_frame>
    <description>community independent, community with home care, community with family support, inpatient rehabilitation, convalescent care, long term care, acute care hospital</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Sleep</condition>
  <condition>Postoperative Complications</condition>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Postoperative Hip fracture patients</arm_group_label>
    <description>The target population will include patients aged 65 years or older admitted with hip fracture to the orthopedic ward at the Juravinski Hospital, a site of Hamilton Health Sciences Corporation in Ontario, Canada.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fitbit® Alta HR Sleep monitoring</intervention_name>
    <description>Patients will be fitted with a Fitbit® Alta HR after surgery, which will monitor sleep quality (sleep duration and number of awakenings) for the duration of hospitalization.</description>
    <arm_group_label>Postoperative Hip fracture patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to orthopedic ward after surgery for repair of hip fracture. Hamilton&#xD;
        Health Sciences Corporation, Juravinski Hospital Site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients recovering from surgery for hip fracture&#xD;
&#xD;
          -  65 years of age or older&#xD;
&#xD;
          -  Able to provide informed consent or has a substitute decision maker able to provide&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bed or wheelchair bound prior to fracture&#xD;
&#xD;
          -  Physical barrier to placement of device (wrist restraints, cast for wrist fracture)&#xD;
&#xD;
          -  Non-operative hip fractures&#xD;
&#xD;
          -  Pathologic hip fracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hamilton Health Sciences Corporation</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8M 1W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>June 5, 2021</last_update_submitted>
  <last_update_submitted_qc>June 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Christopher Patterson</investigator_full_name>
    <investigator_title>Professor Emeritus</investigator_title>
  </responsible_party>
  <keyword>Hip fractures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03776526
org study id: REST-UP
nct id: NCT03776526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: Number of steps per 24-hour day taken by patients during hospital admission after hip fracture repair.
time frame: Through study completion, on average 1 week
description: Mean daily step count as measured by Fitbit®
measure: Delirium rate (incidence)
time frame: Through study completion, on average 1 week
description: Delirium assessed by confusion assessment method (CAM)
measure: Length of stay in hospital
time frame: Through study completion, on average 1 week
description: Days from admission until discharge from hospital
measure: Post-operative complications
time frame: Through study completion, on average 1 week
description: Stroke, Cardiac event, Pneumonia, Venous thromboembolism, GI tract bleed, Urinary tract infections, Postoperative anemia, Acute Kidney Injury, and Pressure sores
measure: 30-day post-discharge mortality
time frame: 30 days post discharge
description: Death within 30 days
measure: 30 day mobility status
time frame: 30 days post discharge
description: Functional Independence Measure - locomotion subscale score
measure: Location of disposition
time frame: Through study completion, on average 1 week
description: community independent, community with home care, community with family support, inpatient rehabilitation, convalescent care, long term care, acute care hospital
measure: Location of disposition at 30 days
time frame: 30 days post discharge
description: community independent, community with home care, community with family support, inpatient rehabilitation, convalescent care, long term care, acute care hospital
arm group label: Postoperative Hip fracture patients
description: The target population will include patients aged 65 years or older admitted with hip fracture to the orthopedic ward at the Juravinski Hospital, a site of Hamilton Health Sciences Corporation in Ontario, Canada.
intervention type: Behavioral
intervention name: Fitbit® Alta HR Sleep monitoring
description: Patients will be fitted with a Fitbit® Alta HR after surgery, which will monitor sleep quality (sleep duration and number of awakenings) for the duration of hospitalization.
arm group label: Postoperative Hip fracture patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: McMaster University
investigator full name: Christopher Patterson
investigator title: Professor Emeritus
mesh term: Postoperative Complications
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: Undecided