xml: <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/NCT06042491</url>
    </required_header>
    <id_info>
      <org_study_id>CTO - TBD</org_study_id>
      <nct_id>NCT06042491</nct_id>
    </id_info>
    <brief_title>The STRIVE Before Surgery Pilot Trial</brief_title>
    <official_title>The STRIVE Before Surgery Pilot Trial: a Vanguard Pragmatic Multicenter Randomized Trial of Structured TRaining to Improve Fitness in a Virtual Environment (STRIVE) Before Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ottawa Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ottawa Hospital Research Institute</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>
        The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence,&#xD;
        and follow-up) associated with participating in a home-based multimodal prehabilitation&#xD;
        program supported through an online platform. Half of the participants will be randomized&#xD;
        into the prehabilitation group, while the other half will be randomized into the control&#xD;
        group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The number of people presenting for surgery, and their risk profile, are&#xD;
        increasing. People presenting for surgery face substantial risk of postoperative adverse&#xD;
        events. Fifteen to 30% of patients suffer a serious medical or surgical complication after&#xD;
        surgery, and 1 in 5 develop a new patient-reported disability that reflects a loss of&#xD;
        independence in day-to-day life. More than 1.4 million inpatient surgical procedures are&#xD;
        performed in Canada each year. Globally, &gt;300 million surgical procedures occur annually. As&#xD;
        an increasing number of people present for surgery, the average risk profile of this&#xD;
        population is rising. Surgical patients are typically older and live with comorbidity. This&#xD;
        means that strategies to improve patient outcomes and reduce resource utilization are&#xD;
        urgently needed. Patients, the public, clinicians, and policy makers participating in 2&#xD;
        separate James Lind Alliance Priority Setting Partnerships (Canada &amp; UK) identified&#xD;
        prehabilitation as a Top 10 priority for perioperative research. Furthermore, prehabilitation&#xD;
        is currently discussed in the popular media as a strategy to improve outcomes for the growing&#xD;
        number of high-risk patients presenting for surgery.&#xD;
  &#xD;
        Overarching Aim: The STRIVE Before Surgery Trial will evaluate three pragmatic elements&#xD;
        (recruitment, adherence, and follow-up) that our experience in prehabilitation research&#xD;
        demonstrate are necessary to support successful, large-scale evaluation. The investigators&#xD;
        will concurrently use implementation science methodology to further refine processes for the&#xD;
        larger trial. As this is a vanguard pilot trial, data from this trial will be combined with&#xD;
        the future, large-scale trial.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        Design, setting and participants: The STRIVE Before Surgery Trial is an assessor blinded&#xD;
        multicenter individual patient parallel-arm vanguard pragmatic randomized controlled trial.&#xD;
  &#xD;
        People =&gt; 18 years old having inpatient abdominal, thoracic, pelvic, head-and-neck or&#xD;
        vascular surgery with expected length of stay of =&gt; 2 days will be included.&#xD;
  &#xD;
        Intervention: The intervention includes 3 aspects (exercise, nutrition and breathing). Our&#xD;
        intervention is a home-based multimodal prehabilitation program supported through an online&#xD;
        platform.&#xD;
  &#xD;
        Outcomes and sample size: Primary outcomes are monthly recruitment, intervention adherence,&#xD;
        retention, and elicitation of patient, clinician and researcher-identified barriers.&#xD;
        Secondary outcomes are days at home in the 30 days after surgery, survival, length of stay,&#xD;
        patient safety indicators, intensive care unit admission, non-home discharge, readmission,&#xD;
        emergency department visits, and health system costs. Our vanguard trial sample size estimate&#xD;
        is informed by a power calculation for the future large-scale trial. For the vanguard trial,&#xD;
        a sample size of 144 directly links to our 3 feasibility outcomes: 1) recruitment of 144&#xD;
        participants over 6 months at our 4 sites will demonstrate our ability to average 6&#xD;
        participants per site per month.&#xD;
  &#xD;
        Expertise: Our team features multidisciplinary clinical and methodological experts,&#xD;
        nationally representative knowledge users and patient representatives.&#xD;
  &#xD;
        Expected outcomes: Knowledge gained from our vanguard trial will directly inform the larger&#xD;
        pragmatic trial, which will be powered to detect a minimally important difference in a&#xD;
        patient-reported outcome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">November 2024</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>Single (Outcomes Assessor)</masking>
      <masking_description>Group allocation will not be indicated in data analyzed by the outcome assessors.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Monthly recruitment</measure>
      <time_frame>1 year</time_frame>
      <description>Recruited patients per center per month will be analyzed descriptively to generate a mean and standard deviation. Recruitment feasibility will be judged based on criteria pre-established that consider the number of available, committed sites in Ontario (&gt;6 defines definitely feasible, 4-5 possibly and &lt;4 infeasible)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention adherence</measure>
      <time_frame>pre-surgery</time_frame>
      <description>The proportion of prescribed prehabilitation tasks adhered to</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention</measure>
      <time_frame>1 month, year 1</time_frame>
      <description>The proportion of participants retained at 30-day patient-reported follow up will be calculated with a 95% confidence interval based on Wilson's method.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Elicitation of patient, clinician and researcher-identified barriers</measure>
      <time_frame>1 year</time_frame>
      <description>For each target group, the frequency of domains identified as barriers will be calculated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Days at home</measure>
      <time_frame>1 month, year 1</time_frame>
      <description>A count of days at home in the 30-days after surgery is a validated patient-centered outcome that can be ascertained from routinely collected data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival</measure>
      <time_frame>1 year</time_frame>
      <description>All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of Stay</measure>
      <time_frame>1 year</time_frame>
      <description>Days from surgical admission to discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Safety Events</measure>
      <time_frame>1 year</time_frame>
      <description>A validated set of in-hospital patient safety indicators will be captured from the index hospitalization record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intensive care unit admission</measure>
      <time_frame>1 year</time_frame>
      <description>Intensive care unit admission captured by administrative data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-home discharge</measure>
      <time_frame>1 year</time_frame>
      <description>Discharge from the index hospitalization via transfer to a non-home location or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-admission</measure>
      <time_frame>1 month, year 1</time_frame>
      <description>Number of re-admissions to hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency department visits</measure>
      <time_frame>1 month, year 1</time_frame>
      <description>Number of emergency department visits</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health system costs</measure>
      <time_frame>1 year</time_frame>
      <description>A validated patient-level costing algorithm will be used to capture all health system costs accrued within 30-days and 1-year after surgery</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Surgery-Complications</condition>
    <condition>Disability Physical</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and &gt;65) and healthy eating recommendations (Canada's Food Guide) documents will be provided to control participants (without active or online support).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prehabilitation intervention</intervention_name>
      <description>The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) aerobic exercise and 3) flexibility using individual, self-directed sessions and instructor-led group sessions. 1-hour individual, self-directed sessions are offered &gt;3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is concurrently accessible as a smart phone app. The nutrition component includes: 1) protein supplementation; 2) nutritional advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years&#xD;
  &#xD;
            2. Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck&#xD;
               or vascular surgery&#xD;
  &#xD;
            3. Expected surgery date between 3 and 12 weeks from enrollment&#xD;
  &#xD;
            4. Valid provincial health insurance number&#xD;
  &#xD;
            5. Access to internet-enabled device&#xD;
  &#xD;
            6. Email address&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Inability to read and communicate in English&#xD;
  &#xD;
            2. Cognitive impairment preventing ability to provide informed consent independently&#xD;
  &#xD;
            3. No telephone/cell phone&#xD;
  &#xD;
            4. Cardiac, neurological or orthopedic procedure&#xD;
  &#xD;
            5. Surgery with no curative intent (palliative surgery)&#xD;
  &#xD;
            6. Patient not interested in participating in the context of their Telephone Assessment&#xD;
               of Physical Activity (TAPA) score&#xD;
  &#xD;
            7. Any of the following cardiovascular conditions:&#xD;
  &#xD;
                 1. Severe valvular heart disease that limits a patient's ability to ambulate on&#xD;
                    level ground, or is associated with syncope or dyspnea&#xD;
  &#xD;
                 2. Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level&#xD;
                    ground, or is associated with syncope or dyspnea&#xD;
  &#xD;
                 3. Recent myocardial infarction (within 6 weeks prior to enrollment - based on the&#xD;
                    Heart and Stroke Foundation's Heart Walk program)&#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>Daniel McIsaac, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Ottawa Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emily Hladkowicz, PhD (c)</last_name>
      <phone>613-798-5555</phone>
      <phone_ext>18629</phone_ext>
      <email>emhladkowicz@toh.ca</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.</ipd_description>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.</ipd_time_frame>
      <ipd_access_criteria>Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042491
  org study id: CTO - TBD
  nct id: NCT06042491
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence,
        and follow-up) associated with participating in a home-based multimodal prehabilitation
        program supported through an online platform. Half of the participants will be randomized
        into the prehabilitation group, while the other half will be randomized into the control
        group.
  Background: The number of people presenting for surgery, and their risk profile, are
        increasing. People presenting for surgery face substantial risk of postoperative adverse
        events. Fifteen to 30% of patients suffer a serious medical or surgical complication after
        surgery, and 1 in 5 develop a new patient-reported disability that reflects a loss of
        independence in day-to-day life. More than 1.4 million inpatient surgical procedures are
        performed in Canada each year. Globally, >300 million surgical procedures occur annually. As
        an increasing number of people present for surgery, the average risk profile of this
        population is rising. Surgical patients are typically older and live with comorbidity. This
        means that strategies to improve patient outcomes and reduce resource utilization are
        urgently needed. Patients, the public, clinicians, and policy makers participating in 2
        separate James Lind Alliance Priority Setting Partnerships (Canada & UK) identified
        prehabilitation as a Top 10 priority for perioperative research. Furthermore, prehabilitation
        is currently discussed in the popular media as a strategy to improve outcomes for the growing
        number of high-risk patients presenting for surgery.
  
        Overarching Aim: The STRIVE Before Surgery Trial will evaluate three pragmatic elements
        (recruitment, adherence, and follow-up) that our experience in prehabilitation research
        demonstrate are necessary to support successful, large-scale evaluation. The investigators
        will concurrently use implementation science methodology to further refine processes for the
        larger trial. As this is a vanguard pilot trial, data from this trial will be combined with
        the future, large-scale trial.
  
        Methods:
  
        Design, setting and participants: The STRIVE Before Surgery Trial is an assessor blinded
        multicenter individual patient parallel-arm vanguard pragmatic randomized controlled trial.
  
        People => 18 years old having inpatient abdominal, thoracic, pelvic, head-and-neck or
        vascular surgery with expected length of stay of => 2 days will be included.
  
        Intervention: The intervention includes 3 aspects (exercise, nutrition and breathing). Our
        intervention is a home-based multimodal prehabilitation program supported through an online
        platform.
  
        Outcomes and sample size: Primary outcomes are monthly recruitment, intervention adherence,
        retention, and elicitation of patient, clinician and researcher-identified barriers.
        Secondary outcomes are days at home in the 30 days after surgery, survival, length of stay,
        patient safety indicators, intensive care unit admission, non-home discharge, readmission,
        emergency department visits, and health system costs. Our vanguard trial sample size estimate
        is informed by a power calculation for the future large-scale trial. For the vanguard trial,
        a sample size of 144 directly links to our 3 feasibility outcomes: 1) recruitment of 144
        participants over 6 months at our 4 sites will demonstrate our ability to average 6
        participants per site per month.
  
        Expertise: Our team features multidisciplinary clinical and methodological experts,
        nationally representative knowledge users and patient representatives.
  
        Expected outcomes: Knowledge gained from our vanguard trial will directly inform the larger
        pragmatic trial, which will be powered to detect a minimally important difference in a
        patient-reported outcome.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Group allocation will not be indicated in data analyzed by the outcome assessors.
  measure: Monthly recruitment
  time frame: 1 year
  description: Recruited patients per center per month will be analyzed descriptively to generate a mean and standard deviation. Recruitment feasibility will be judged based on criteria pre-established that consider the number of available, committed sites in Ontario (>6 defines definitely feasible, 4-5 possibly and <4 infeasible)
  measure: Intervention adherence
  time frame: pre-surgery
  description: The proportion of prescribed prehabilitation tasks adhered to
  measure: Retention
  time frame: 1 month, year 1
  description: The proportion of participants retained at 30-day patient-reported follow up will be calculated with a 95% confidence interval based on Wilson's method.
  measure: Elicitation of patient, clinician and researcher-identified barriers
  time frame: 1 year
  description: For each target group, the frequency of domains identified as barriers will be calculated.
  measure: Days at home
  time frame: 1 month, year 1
  description: A count of days at home in the 30-days after surgery is a validated patient-centered outcome that can be ascertained from routinely collected data
  measure: Survival
  time frame: 1 year
  description: All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics
  measure: Length of Stay
  time frame: 1 year
  description: Days from surgical admission to discharge
  measure: Patient Safety Events
  time frame: 1 year
  description: A validated set of in-hospital patient safety indicators will be captured from the index hospitalization record
  measure: Intensive care unit admission
  time frame: 1 year
  description: Intensive care unit admission captured by administrative data
  measure: Non-home discharge
  time frame: 1 year
  description: Discharge from the index hospitalization via transfer to a non-home location or death
  measure: Re-admission
  time frame: 1 month, year 1
  description: Number of re-admissions to hospital
  measure: Emergency department visits
  time frame: 1 month, year 1
  description: Number of emergency department visits
  measure: Health system costs
  time frame: 1 year
  description: A validated patient-level costing algorithm will be used to capture all health system costs accrued within 30-days and 1-year after surgery
  arm group label: Intervention
  arm group type: Experimental
  description: The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.
  arm group label: Control
  arm group type: No Intervention
  description: To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and >65) and healthy eating recommendations (Canada's Food Guide) documents will be provided to control participants (without active or online support).
  intervention type: Behavioral
  intervention name: Prehabilitation intervention
  description: The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) aerobic exercise and 3) flexibility using individual, self-directed sessions and instructor-led group sessions. 1-hour individual, self-directed sessions are offered >3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is concurrently accessible as a smart phone app. The nutrition component includes: 1) protein supplementation; 2) nutritional advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel McIsaac, MD
  role: Principal Investigator
  affiliation: The Ottawa Hospital
  last name: Emily Hladkowicz, PhD (c)
  phone: 613-798-5555
  phone ext: 18629
  email: emhladkowicz@toh.ca
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.
  ipd access criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.