<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/NCT03277053</url>
  </required_header>
  <id_info>
    <org_study_id>McgillGensurgAPPRCT</org_study_id>
    <nct_id>NCT03277053</nct_id>
  </id_info>
  <brief_title>A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery</brief_title>
  <official_title>A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Liane S. Feldman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society of American Gastrointestinal and Endoscopic Surgeons</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A randomized control trial on patients undergoing laparoscopic colorectal resection in an&#xD;
      Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application&#xD;
      containing guidelines, information, and tailored feedback. The hypothesis is that the&#xD;
      application will improve adherence to the ERP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative&#xD;
      morbidity and shorten length of hospital stay with no increase in readmission rates. However,&#xD;
      poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of&#xD;
      mobile device applications has the potential to improve patient compliance with treatment&#xD;
      guidelines. We recently developed and pilot tested a mobile app to support an ERP for&#xD;
      colorectal surgery which collects patient-reported recovery information and engages patients&#xD;
      as stakeholders in their recovery process. The overall aim of this study is to estimate the&#xD;
      extent to which the use of this mobile device app impacts adherence to postoperative ERP&#xD;
      elements in comparison to standard preoperative education.&#xD;
&#xD;
      Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult&#xD;
      patients with colorectal diseases planned for surgical resection.&#xD;
&#xD;
      Participants will be randomly assigned into one of two groups:&#xD;
&#xD;
        1. usual perioperative education and audit, or&#xD;
&#xD;
        2. a mobile device application for postoperative education and self-audit.&#xD;
&#xD;
      The intervention will be delivered through a tablet present at the bedside with an&#xD;
      application which links education, recovery planning, and daily self-assessment to a plan of&#xD;
      care. It educates patients about daily recovery milestones and track their adherence. The&#xD;
      primary outcome will be patient adherence to postoperative enhanced recovery elements. Other&#xD;
      targeted outcomes include self-reported recovery, satisfaction and patient activation.&#xD;
      According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted&#xD;
      for this trial.&#xD;
&#xD;
      Significance: This study will contribute evidence regarding the use of mobile device&#xD;
      technology for education and the direct involvement of patients as stakeholders in&#xD;
      postoperative recovery.&#xD;
&#xD;
      The study findings have the potential to increase patient engagement in the care pathway,&#xD;
      which has the potential to increase compliance to pathway elements and improve postoperative&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2016</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.</measure>
    <time_frame>postoperative day 2</time_frame>
    <description>Questionnaire including 5 pathway interventions that involve patient participation during the first 48 hours after surgery (mobilization, gum chewing, consumption of oral liquids, breathing exercises, nutritional supplement).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>one month</time_frame>
    <description>Number of days spent in the hospital after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>one month</time_frame>
    <description>Comprehensive complication index (CCI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful Recovery</measure>
    <time_frame>postoperative day 4</time_frame>
    <description>Discharge by postoperative day 4 with no complications.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Colorectal Disorders</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients receive an ipad with no app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile application no stoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile application stoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who receive a stoma receive an ipad containing the app and are instructed how to use it.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile application</intervention_name>
    <description>A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback</description>
    <arm_group_label>Mobile application no stoma</arm_group_label>
    <arm_group_label>Mobile application stoma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control.</intervention_name>
    <description>Patient receive an ipad with no application.</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective laparoscopic colorectal resection.&#xD;
&#xD;
          -  Proficient in english or french&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intellectual disabilities&#xD;
&#xD;
          -  major simultaneous procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liane Feldman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal general Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>h3g1a4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>March 22, 2018</last_update_submitted>
  <last_update_submitted_qc>March 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Dr. Liane S. Feldman</investigator_full_name>
    <investigator_title>Professor, Department of Surgery, McGill University Director, General Surgery Clinical Teaching Unit, Montreal General Hospital. Director, Division of General Surgery at the MUHC and McGill University. Program Director, MIS Fellowship Program.</investigator_title>
  </responsible_party>
  <keyword>colorectal</keyword>
  <keyword>laparoscopic</keyword>
  <keyword>application</keyword>
  <keyword>ERP</keyword>
  <keyword>adherence</keyword>
  <keyword>mobile</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03277053
org study id: McgillGensurgAPPRCT
nct id: NCT03277053
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A randomized control trial on patients undergoing laparoscopic colorectal resection in an
      Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application
      containing guidelines, information, and tailored feedback. The hypothesis is that the
      application will improve adherence to the ERP.
Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative
      morbidity and shorten length of hospital stay with no increase in readmission rates. However,
      poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of
      mobile device applications has the potential to improve patient compliance with treatment
      guidelines. We recently developed and pilot tested a mobile app to support an ERP for
      colorectal surgery which collects patient-reported recovery information and engages patients
      as stakeholders in their recovery process. The overall aim of this study is to estimate the
      extent to which the use of this mobile device app impacts adherence to postoperative ERP
      elements in comparison to standard preoperative education.

      Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult
      patients with colorectal diseases planned for surgical resection.

      Participants will be randomly assigned into one of two groups:

        1. usual perioperative education and audit, or

        2. a mobile device application for postoperative education and self-audit.

      The intervention will be delivered through a tablet present at the bedside with an
      application which links education, recovery planning, and daily self-assessment to a plan of
      care. It educates patients about daily recovery milestones and track their adherence. The
      primary outcome will be patient adherence to postoperative enhanced recovery elements. Other
      targeted outcomes include self-reported recovery, satisfaction and patient activation.
      According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted
      for this trial.

      Significance: This study will contribute evidence regarding the use of mobile device
      technology for education and the direct involvement of patients as stakeholders in
      postoperative recovery.

      The study findings have the potential to increase patient engagement in the care pathway,
      which has the potential to increase compliance to pathway elements and improve postoperative
      outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
time frame: postoperative day 2
description: Questionnaire including 5 pathway interventions that involve patient participation during the first 48 hours after surgery (mobilization, gum chewing, consumption of oral liquids, breathing exercises, nutritional supplement).
measure: Length of stay
time frame: one month
description: Number of days spent in the hospital after surgery
measure: Complications
time frame: one month
description: Comprehensive complication index (CCI)
measure: Successful Recovery
time frame: postoperative day 4
description: Discharge by postoperative day 4 with no complications.
arm group label: control
arm group type: Sham Comparator
description: Patients receive an ipad with no app.
arm group label: Mobile application no stoma
arm group type: Experimental
description: Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.
arm group label: Mobile application stoma
arm group type: Experimental
description: Patients who receive a stoma receive an ipad containing the app and are instructed how to use it.
intervention type: Device
intervention name: Mobile application
description: A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback
arm group label: Mobile application no stoma
arm group label: Mobile application stoma
intervention type: Other
intervention name: Control.
description: Patient receive an ipad with no application.
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Liane Feldman, MD
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Dr. Liane S. Feldman
investigator title: Professor, Department of Surgery, McGill University Director, General Surgery Clinical Teaching Unit, Montreal General Hospital. Director, Division of General Surgery at the MUHC and McGill University. Program Director, MIS Fellowship Program.
sharing ipd: No