<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/NCT04493606</url>
  </required_header>
  <id_info>
    <org_study_id>ProACTIVE Implementation</org_study_id>
    <nct_id>NCT04493606</nct_id>
  </id_info>
  <brief_title>Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting</brief_title>
  <official_title>Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting to Improve Physical Activity Among People With Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rick Hansen Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</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>
      There is a significant drop in physical activity among people with spinal cord injury in the&#xD;
      months following discharge from rehabilitation. The ProACTIVE toolkit is a guide to promote&#xD;
      physical activity to clients with spinal cord injury that has demonstrated potential to help&#xD;
      address this sensitive time frame for physical inactivity. The toolkit was co- developed with&#xD;
      300 physiotherapists, community members with spinal cord injury, and university researchers&#xD;
      and has been shown to improve physical activity and fitness in this population.&#xD;
      Physiotherapists will refer clients to peer coaches with spinal cord injury who will&#xD;
      implement the toolkit. The investigators will assess how well the toolkit is used and its&#xD;
      effectiveness to improve physical activity levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose 1 (arms 1 and 2): To evaluate the effect of referral to peer-led coaching, guided by&#xD;
      the ProACTIVE SCI intervention, on physical activity behaviour, health, and quality of life&#xD;
      outcomes among people with SCI.&#xD;
&#xD;
      Procedure overview: Participants will complete survey measures (~45 minutes) at&#xD;
      baseline/discharge, 2 months, 6 months post discharge, and 1-year follow-up. Participants&#xD;
      will also complete a semi-structured interview to assess satisfaction with the intervention&#xD;
      at 6 months. Participants in the intervention group will receive an initial assessment (~1&#xD;
      hour) and 10 physical activity coaching sessions (~15 minutes each). A total time commitment&#xD;
      of ~6.5 hours is expected over one year.&#xD;
&#xD;
      Design: For pragmatic and ethical reasons, single-group, repeated measures design will be&#xD;
      used where interested participants will receive the intervention.&#xD;
&#xD;
      Procedure: Patients who are interested in participating will be enrolled in the intervention&#xD;
      and will receive the ProACTIVE SCI intervention coaching. Patients who are not interested in&#xD;
      participating will be re-contacted before discharge and/or at 3 months post-discharge to&#xD;
      gauge interest. For those who consent during their hospital stay, a two-page quick-sheet will&#xD;
      be filled out at discharge to record any physical activity coaching information collected&#xD;
      during their hospital stay as part of usual care. (Please see Section 9 for the &quot;GF Strong&#xD;
      inpatient/ form&quot; and &quot;GF Strong outpatient form&quot; that is currently used in practice). The&#xD;
      quick-sheet and any exercise prescriptions developed will be transferred to the SCI BC peers.&#xD;
      If possible, SCI BC peers will contact the client in-person or over video-conference before&#xD;
      discharge to begin coaching, otherwise SCI BC peers will contact the patient to begin&#xD;
      coaching sessions in the community post-discharge. SCI BC peers will carry out the physical&#xD;
      activity coaching sessions guided by the ProACTIVE SCI intervention with the exception that&#xD;
      exercise prescriptions cannot be made by the peers. If exercise prescriptions are needed,&#xD;
      referral to an adapted personal trainer in the community will be made. Coaching sessions will&#xD;
      be provided either in-person, using video teleconferencing technology or telephone if needed.&#xD;
      Ten 15-minute sessions will be scheduled in accordance with patient needs and readiness,&#xD;
      however, as a general structure, one coaching session will be provided each month for months&#xD;
      1-3, two coaching sessions per month in months 4-6, with a follow-up before one year. The&#xD;
      peer coaches will make up to 5 attempts to reschedule a missed coaching session.&#xD;
&#xD;
      Sample size estimate: Based on feasibility estimates calculated using number of patients&#xD;
      admitted yearly to GF Strong (n=100), an estimated 70% discharged to home (n=70; remaining&#xD;
      30% discharged to long-term care or other), approximately 55% of patients willing to consent&#xD;
      over the 3 month follow-up period, and a 20% dropout estimate (based on previous experience&#xD;
      in conducting studies in this population) an estimated n=30 individuals will be recruited to&#xD;
      the intervention group (see Figure 2).&#xD;
&#xD;
      To ensure the sample size based on feasibility is adequately powered to detect an effect on&#xD;
      physical activity, the investigators conducted a power calculation based on a previous&#xD;
      randomized controlled trial in the in-patient setting with individuals with spinal cord&#xD;
      injury. Physiotherapists delivered a bi-weekly behavioural coaching intervention to 39&#xD;
      individuals with SCI and physical activity was assessed at baseline, discharge, 6-months, and&#xD;
      one-year post-discharge. A large-sized effect was observed at 6 months (d=0.89) for&#xD;
      self-reported physical activity. Given the quasi-experimental design, the investigators are&#xD;
      powering for a more modest between groups difference (d = .75). Eight participants/condition&#xD;
      (N = 16) are needed to yield a significant effect of this magnitude in a repeated measures&#xD;
      ANOVA, with β = .80 and α = .05. Thus, the feasibility-based projected sample size is&#xD;
      adequate to detect a significant effect of the intervention on physical activity in this&#xD;
      context.&#xD;
&#xD;
      Statistical Analysis: One-way repeated measures ANOVA&#xD;
&#xD;
      Purpose 2 (arm 3): Evaluate, understand, and document the implementation process of&#xD;
      physiotherapists and peers with SCI delivering the ProACTIVE SCI intervention&#xD;
&#xD;
      Procedure overview: Clinicians and SCI BC Peers will receive a two-day training (2 hours each&#xD;
      day) on how to deliver the ProACTIVE intervention. Clinicians and SCI BC Peers will be&#xD;
      supported with monitoring and feedback for the first two months of delivering the&#xD;
      intervention to clients and community of practice meetings as needed. 20-minute surveys will&#xD;
      be administered before and immediately after training, as well as at 2 months and 6 months&#xD;
      after starting implementation. One-hour semi-structured interviews will be conducted at 6&#xD;
      months. A total time commitment of ~18.5 hours is expected over one year for the clinicians.&#xD;
      SCI BC Peers will deliver 10x15 minute coaching sessions to ~ 10 participants each for a&#xD;
      total time commitment of 43.5 hours over one year.&#xD;
&#xD;
      Design: Within-subject, repeated measures.&#xD;
&#xD;
      Participants: As the aim of this project is to deliver the intervention using a pragmatic&#xD;
      approach, volunteer physiotherapists from GF Strong and SCI BC peer coordinators who are&#xD;
      interested in delivering the ProACTIVE SCI intervention will be included in this objective.&#xD;
&#xD;
      Sample size estimate: The study is powered to detect a significant within-subject effect over&#xD;
      time on the theoretical domains framework (TDF) measures. A previous evaluation of the&#xD;
      ProACTIVE implementation training amongst physiotherapists, when using within subject&#xD;
      pre-post analyses, demonstrated a very large effect size across TDF outcomes (f=.867). A&#xD;
      minimum of five participants are needed to yield a significant effect of this magnitude in a&#xD;
      within-subject, repeated measures ANOVA (4 time points), with β = .80, α = .05, and a&#xD;
      conservative 0.25 correlation among repeated measures.&#xD;
&#xD;
      Statistical Analysis: One-way repeated measure ANOVA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 19, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year</measure>
    <time_frame>Baseline, 1 month, 6 month, 1 year</time_frame>
    <description>Measures include the Leisure Time Physical Activity Questionnaire for People with SCI, which is a self-report measure that assesses minutes of mild, moderate, and vigorous intensity leisure time physical activity (i.e., activity that requires physical exertion and that one chooses to do in their free time) that is broken down into strength training and aerobic activity performed over the past seven days. Lower scores reflect less participation in leisure time physical activity. Support for the Leisure Time Physical Activity Questionnaire's criterion validity and test-retest reliability has been previously demonstrated in a sample of 103 men and women with SCI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychosocial predictors of physical activity</measure>
    <time_frame>Baseline, 1 month, 6 month, 1 year</time_frame>
    <description>Psychosocial predictors of physical activity will be assessed using a survey based on the Health Action Process Approach (HAPA) model. Measures of the HAPA constructs are drawn from existing measures and previous SCI studies where possible. All items are assessed on a 7-point Likert scale ranging from 1='strongly disagree' to 7='strongly agree'. The survey will be recorded either electronically or with pen and paper depending on the respondent's preference. Survey will take approximately 25 minutes to complete, and will assess constructs related to exercise such as perceived risks, self- efficacy, planning, and social support. The demographics questionnaire will also be administered with this measure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Determinants of implementation behaviour for interventionists</measure>
    <time_frame>Baseline, 1 month, 6 month, 1 year</time_frame>
    <description>Intervention delivers will be asked to complete an online implementation questionnaire guided by the theoretical domains framework to assess factors that affect delivery of the intervention. The questionnaire consists of 40 questions; eight questions on a 6-point Likert scale where higher scores indicated greater implementation of the toolkit, and 32 questions on an 8-point Likert scale where higher scores indicate greater agreement with factors associated with the implementation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Semi-structured interviews- interventionists</measure>
    <time_frame>6 months</time_frame>
    <description>Sixty-minute individual interviews will be conducted. Semi-structured interviews will explore interventionist experiences, needs, and factors (barriers and facilitators) that affect physical activity coaching behaviour guided by the ProACTIVE SCI intervention. Interviews will be recorded and transcribed verbatim</description>
  </other_outcome>
  <other_outcome>
    <measure>Semi-structured interviews- Patients</measure>
    <time_frame>1 year</time_frame>
    <description>Sixty-minute individual interviews will be conducted. Semi-structured interviews will be conducted over the phone or video conference. Semi-structured interviews will explore the impacts of the intervention on physical and mental health, use of healthcare services, quality of life, and function, as well as participants' satisfaction and future recommendations for the coaching intervention. Interviews will be recorded and transcribed verbatim.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Intervention Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCI patients receiving the physical activity coaching (Objective 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention- Interventionists</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventionists receiving physical activity coaching training (Objective 2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SCI ProACTIVE Coaching (objective 1)</intervention_name>
    <description>Peer coaches will conduct an assessment to understand patient's readiness, goals, barriers, preferences, and access to physical activity resources and mutually select tailored physical activity-enhancing strategies based on the assessment. These strategies include education (SCI exercise guidelines, safety, benefits, basics of physical activity, behaviour change techniques) and referral to appropriate peers, programs, and organizations. Goals will be based on the SCI Fitness Guidelines (targeting a goal of 20min of moderate to vigorous intensity aerobic exercise + 3 sets of strength training exercises for each major functioning muscle group at a moderate to vigorous intensity each 2x/week) and if ready, the Canadian SCI Physical Activity Guidelines (30 min 3x/week of moderate to vigorous intensity aerobic exercise + strength training 2x/ week). Ten 15-minute, video-conference or telephone sessions will be scheduled in accordance with patient needs and readiness with the peer coaches.</description>
    <arm_group_label>Intervention Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Implementation Intervention (objective 2)</intervention_name>
    <description>A training on how to deliver the ProACTIVE intervention will be delivered. Day 1 training will include an overview of the intervention, demonstration of the delivery of the intervention, and behavioural practice. Interventionists will practice delivering the intervention and record issues or questions to bring to the day 2 training. Day 2 training will include a refresher on intervention content, barriers identified during in-clinic/community practice will be addressed, and further behavioural practice with volunteer clients with additional feedback provided.&#xD;
The trainer (Dr. Jasmin Ma) will provide monitoring and feedback during the first two months of implementation. Community of practice meetings will be held as needed to discuss challenges and facilitators to implementation. Feedback provided during community of practice meetings will be collected and used for iterative quality improvement of the intervention approaches.</description>
    <arm_group_label>Intervention- Interventionists</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  traumatic or non-traumatic spinal cord injury&#xD;
&#xD;
          -  do not require ventilatory assistance, and&#xD;
&#xD;
          -  have no medical contraindications to exercise identified by the care team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled symptoms of cardiovascular disease or cardiopulmonary problems/disease.&#xD;
&#xD;
          -  Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory&#xD;
             Panel classification)&#xD;
&#xD;
          -  Any unstable medical/psychiatric condition or substance abuse disorder that is likely&#xD;
             to affect their ability to complete this study.- Any cognitive dysfunction or language&#xD;
             barrier that would prevent subjects from following English instructions.&#xD;
&#xD;
          -  Participants may be excluded at the discretion of the principal investigator due to&#xD;
             other, unforeseen, safety issues.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Martin Ginis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GF Strong Rehabilitation Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 2G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Bandura, A. (1997). Self-efficacy: The Exercise of Control. New York: W.H. Freeman &amp; Co.</citation>
  </reference>
  <reference>
    <citation>Brawley LR, Arbour-Nicitopoulos KP, Martin Ginis KA. Developing physical activity interventions for adults with spinal cord injury. Part 3: a pilot feasibility study of an intervention to increase self-managed physical activity. Rehabil Psychol. 2013 Aug;58(3):316-21. doi: 10.1037/a0032814.</citation>
    <PMID>23978087</PMID>
  </reference>
  <reference>
    <citation>Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.</citation>
    <PMID>3920711</PMID>
  </reference>
  <reference>
    <citation>Cowan RE, Nash MS, Anderson KD. Exercise participation barrier prevalence and association with exercise participation status in individuals with spinal cord injury. Spinal Cord. 2013 Jan;51(1):27-32. doi: 10.1038/sc.2012.53. Epub 2012 May 15.</citation>
    <PMID>22584283</PMID>
  </reference>
  <reference>
    <citation>Ma JK, Cheifetz O, Todd KR, Chebaro C, Phang SH, Shaw RB, Whaley KJ, Martin Ginis KA. Co-development of a physiotherapist-delivered physical activity intervention for adults with spinal cord injury. Spinal Cord. 2020 Jul;58(7):778-786. doi: 10.1038/s41393-020-0422-x. Epub 2020 Jan 22.</citation>
    <PMID>31969687</PMID>
  </reference>
  <reference>
    <citation>Ginis KA, Hicks AL, Latimer AE, Warburton DE, Bourne C, Ditor DS, Goodwin DL, Hayes KC, McCartney N, McIlraith A, Pomerleau P, Smith K, Stone JA, Wolfe DL. The development of evidence-informed physical activity guidelines for adults with spinal cord injury. Spinal Cord. 2011 Nov;49(11):1088-96. doi: 10.1038/sc.2011.63. Epub 2011 Jun 7.</citation>
    <PMID>21647164</PMID>
  </reference>
  <reference>
    <citation>Martin Ginis KA, Phang SH, Latimer AE, Arbour-Nicitopoulos KP. Reliability and validity tests of the leisure time physical activity questionnaire for people with spinal cord injury. Arch Phys Med Rehabil. 2012 Apr;93(4):677-82. doi: 10.1016/j.apmr.2011.11.005. Epub 2012 Feb 13.</citation>
    <PMID>22336103</PMID>
  </reference>
  <reference>
    <citation>Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.</citation>
    <PMID>3432232</PMID>
  </reference>
  <reference>
    <citation>Scholz, U., Sniehotta, F. F., &amp; Schwarzer, R. (2005). Predicting physical exercise in cardiac rehabilitation: The role of phase-specific self-efficacy beliefs. Journal of Sport and Exercise Psychology, 27(2), 135-151</citation>
  </reference>
  <reference>
    <citation>Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.</citation>
    <PMID>21767036</PMID>
  </reference>
  <reference>
    <citation>Sniehotta, F. F., Scholz, U., &amp; Schwarzer, R. (2005). Bridging the intention-behaviour gap: Planning, self-efficacy, and action control in the adoption and maintenance of physical exercise. Psychology &amp; Health, 20(2), 143-160. https://doi.org/10.1080/08870440512331317670</citation>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Kathleen Martin Ginis</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <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/NCT04493606
org study id: ProACTIVE Implementation
nct id: NCT04493606
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a significant drop in physical activity among people with spinal cord injury in the
      months following discharge from rehabilitation. The ProACTIVE toolkit is a guide to promote
      physical activity to clients with spinal cord injury that has demonstrated potential to help
      address this sensitive time frame for physical inactivity. The toolkit was co- developed with
      300 physiotherapists, community members with spinal cord injury, and university researchers
      and has been shown to improve physical activity and fitness in this population.
      Physiotherapists will refer clients to peer coaches with spinal cord injury who will
      implement the toolkit. The investigators will assess how well the toolkit is used and its
      effectiveness to improve physical activity levels.
Purpose 1 (arms 1 and 2): To evaluate the effect of referral to peer-led coaching, guided by
      the ProACTIVE SCI intervention, on physical activity behaviour, health, and quality of life
      outcomes among people with SCI.

      Procedure overview: Participants will complete survey measures (~45 minutes) at
      baseline/discharge, 2 months, 6 months post discharge, and 1-year follow-up. Participants
      will also complete a semi-structured interview to assess satisfaction with the intervention
      at 6 months. Participants in the intervention group will receive an initial assessment (~1
      hour) and 10 physical activity coaching sessions (~15 minutes each). A total time commitment
      of ~6.5 hours is expected over one year.

      Design: For pragmatic and ethical reasons, single-group, repeated measures design will be
      used where interested participants will receive the intervention.

      Procedure: Patients who are interested in participating will be enrolled in the intervention
      and will receive the ProACTIVE SCI intervention coaching. Patients who are not interested in
      participating will be re-contacted before discharge and/or at 3 months post-discharge to
      gauge interest. For those who consent during their hospital stay, a two-page quick-sheet will
      be filled out at discharge to record any physical activity coaching information collected
      during their hospital stay as part of usual care. (Please see Section 9 for the "GF Strong
      inpatient/ form" and "GF Strong outpatient form" that is currently used in practice). The
      quick-sheet and any exercise prescriptions developed will be transferred to the SCI BC peers.
      If possible, SCI BC peers will contact the client in-person or over video-conference before
      discharge to begin coaching, otherwise SCI BC peers will contact the patient to begin
      coaching sessions in the community post-discharge. SCI BC peers will carry out the physical
      activity coaching sessions guided by the ProACTIVE SCI intervention with the exception that
      exercise prescriptions cannot be made by the peers. If exercise prescriptions are needed,
      referral to an adapted personal trainer in the community will be made. Coaching sessions will
      be provided either in-person, using video teleconferencing technology or telephone if needed.
      Ten 15-minute sessions will be scheduled in accordance with patient needs and readiness,
      however, as a general structure, one coaching session will be provided each month for months
      1-3, two coaching sessions per month in months 4-6, with a follow-up before one year. The
      peer coaches will make up to 5 attempts to reschedule a missed coaching session.

      Sample size estimate: Based on feasibility estimates calculated using number of patients
      admitted yearly to GF Strong (n=100), an estimated 70% discharged to home (n=70; remaining
      30% discharged to long-term care or other), approximately 55% of patients willing to consent
      over the 3 month follow-up period, and a 20% dropout estimate (based on previous experience
      in conducting studies in this population) an estimated n=30 individuals will be recruited to
      the intervention group (see Figure 2).

      To ensure the sample size based on feasibility is adequately powered to detect an effect on
      physical activity, the investigators conducted a power calculation based on a previous
      randomized controlled trial in the in-patient setting with individuals with spinal cord
      injury. Physiotherapists delivered a bi-weekly behavioural coaching intervention to 39
      individuals with SCI and physical activity was assessed at baseline, discharge, 6-months, and
      one-year post-discharge. A large-sized effect was observed at 6 months (d=0.89) for
      self-reported physical activity. Given the quasi-experimental design, the investigators are
      powering for a more modest between groups difference (d = .75). Eight participants/condition
      (N = 16) are needed to yield a significant effect of this magnitude in a repeated measures
      ANOVA, with β = .80 and α = .05. Thus, the feasibility-based projected sample size is
      adequate to detect a significant effect of the intervention on physical activity in this
      context.

      Statistical Analysis: One-way repeated measures ANOVA

      Purpose 2 (arm 3): Evaluate, understand, and document the implementation process of
      physiotherapists and peers with SCI delivering the ProACTIVE SCI intervention

      Procedure overview: Clinicians and SCI BC Peers will receive a two-day training (2 hours each
      day) on how to deliver the ProACTIVE intervention. Clinicians and SCI BC Peers will be
      supported with monitoring and feedback for the first two months of delivering the
      intervention to clients and community of practice meetings as needed. 20-minute surveys will
      be administered before and immediately after training, as well as at 2 months and 6 months
      after starting implementation. One-hour semi-structured interviews will be conducted at 6
      months. A total time commitment of ~18.5 hours is expected over one year for the clinicians.
      SCI BC Peers will deliver 10x15 minute coaching sessions to ~ 10 participants each for a
      total time commitment of 43.5 hours over one year.

      Design: Within-subject, repeated measures.

      Participants: As the aim of this project is to deliver the intervention using a pragmatic
      approach, volunteer physiotherapists from GF Strong and SCI BC peer coordinators who are
      interested in delivering the ProACTIVE SCI intervention will be included in this objective.

      Sample size estimate: The study is powered to detect a significant within-subject effect over
      time on the theoretical domains framework (TDF) measures. A previous evaluation of the
      ProACTIVE implementation training amongst physiotherapists, when using within subject
      pre-post analyses, demonstrated a very large effect size across TDF outcomes (f=.867). A
      minimum of five participants are needed to yield a significant effect of this magnitude in a
      within-subject, repeated measures ANOVA (4 time points), with β = .80, α = .05, and a
      conservative 0.25 correlation among repeated measures.

      Statistical Analysis: One-way repeated measure ANOVA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year
time frame: Baseline, 1 month, 6 month, 1 year
description: Measures include the Leisure Time Physical Activity Questionnaire for People with SCI, which is a self-report measure that assesses minutes of mild, moderate, and vigorous intensity leisure time physical activity (i.e., activity that requires physical exertion and that one chooses to do in their free time) that is broken down into strength training and aerobic activity performed over the past seven days. Lower scores reflect less participation in leisure time physical activity. Support for the Leisure Time Physical Activity Questionnaire's criterion validity and test-retest reliability has been previously demonstrated in a sample of 103 men and women with SCI.
measure: Psychosocial predictors of physical activity
time frame: Baseline, 1 month, 6 month, 1 year
description: Psychosocial predictors of physical activity will be assessed using a survey based on the Health Action Process Approach (HAPA) model. Measures of the HAPA constructs are drawn from existing measures and previous SCI studies where possible. All items are assessed on a 7-point Likert scale ranging from 1='strongly disagree' to 7='strongly agree'. The survey will be recorded either electronically or with pen and paper depending on the respondent's preference. Survey will take approximately 25 minutes to complete, and will assess constructs related to exercise such as perceived risks, self- efficacy, planning, and social support. The demographics questionnaire will also be administered with this measure.
measure: Determinants of implementation behaviour for interventionists
time frame: Baseline, 1 month, 6 month, 1 year
description: Intervention delivers will be asked to complete an online implementation questionnaire guided by the theoretical domains framework to assess factors that affect delivery of the intervention. The questionnaire consists of 40 questions; eight questions on a 6-point Likert scale where higher scores indicated greater implementation of the toolkit, and 32 questions on an 8-point Likert scale where higher scores indicate greater agreement with factors associated with the implementation.
measure: Semi-structured interviews- interventionists
time frame: 6 months
description: Sixty-minute individual interviews will be conducted. Semi-structured interviews will explore interventionist experiences, needs, and factors (barriers and facilitators) that affect physical activity coaching behaviour guided by the ProACTIVE SCI intervention. Interviews will be recorded and transcribed verbatim
measure: Semi-structured interviews- Patients
time frame: 1 year
description: Sixty-minute individual interviews will be conducted. Semi-structured interviews will be conducted over the phone or video conference. Semi-structured interviews will explore the impacts of the intervention on physical and mental health, use of healthcare services, quality of life, and function, as well as participants' satisfaction and future recommendations for the coaching intervention. Interviews will be recorded and transcribed verbatim.
arm group label: Intervention Patients
arm group type: Experimental
description: SCI patients receiving the physical activity coaching (Objective 1)
arm group label: Intervention- Interventionists
arm group type: Experimental
description: Interventionists receiving physical activity coaching training (Objective 2)
intervention type: Other
intervention name: SCI ProACTIVE Coaching (objective 1)
description: Peer coaches will conduct an assessment to understand patient's readiness, goals, barriers, preferences, and access to physical activity resources and mutually select tailored physical activity-enhancing strategies based on the assessment. These strategies include education (SCI exercise guidelines, safety, benefits, basics of physical activity, behaviour change techniques) and referral to appropriate peers, programs, and organizations. Goals will be based on the SCI Fitness Guidelines (targeting a goal of 20min of moderate to vigorous intensity aerobic exercise + 3 sets of strength training exercises for each major functioning muscle group at a moderate to vigorous intensity each 2x/week) and if ready, the Canadian SCI Physical Activity Guidelines (30 min 3x/week of moderate to vigorous intensity aerobic exercise + strength training 2x/ week). Ten 15-minute, video-conference or telephone sessions will be scheduled in accordance with patient needs and readiness with the peer coaches.
arm group label: Intervention Patients
intervention type: Behavioral
intervention name: Implementation Intervention (objective 2)
description: A training on how to deliver the ProACTIVE intervention will be delivered. Day 1 training will include an overview of the intervention, demonstration of the delivery of the intervention, and behavioural practice. Interventionists will practice delivering the intervention and record issues or questions to bring to the day 2 training. Day 2 training will include a refresher on intervention content, barriers identified during in-clinic/community practice will be addressed, and further behavioural practice with volunteer clients with additional feedback provided.
The trainer (Dr. Jasmin Ma) will provide monitoring and feedback during the first two months of implementation. Community of practice meetings will be held as needed to discuss challenges and facilitators to implementation. Feedback provided during community of practice meetings will be collected and used for iterative quality improvement of the intervention approaches.
arm group label: Intervention- Interventionists
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Martin Ginis, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
citation: Bandura, A. (1997). Self-efficacy: The Exercise of Control. New York: W.H. Freeman & Co.
citation: Brawley LR, Arbour-Nicitopoulos KP, Martin Ginis KA. Developing physical activity interventions for adults with spinal cord injury. Part 3: a pilot feasibility study of an intervention to increase self-managed physical activity. Rehabil Psychol. 2013 Aug;58(3):316-21. doi: 10.1037/a0032814.
PMID: 23978087
citation: Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
PMID: 3920711
citation: Cowan RE, Nash MS, Anderson KD. Exercise participation barrier prevalence and association with exercise participation status in individuals with spinal cord injury. Spinal Cord. 2013 Jan;51(1):27-32. doi: 10.1038/sc.2012.53. Epub 2012 May 15.
PMID: 22584283
citation: Ma JK, Cheifetz O, Todd KR, Chebaro C, Phang SH, Shaw RB, Whaley KJ, Martin Ginis KA. Co-development of a physiotherapist-delivered physical activity intervention for adults with spinal cord injury. Spinal Cord. 2020 Jul;58(7):778-786. doi: 10.1038/s41393-020-0422-x. Epub 2020 Jan 22.
PMID: 31969687
citation: Ginis KA, Hicks AL, Latimer AE, Warburton DE, Bourne C, Ditor DS, Goodwin DL, Hayes KC, McCartney N, McIlraith A, Pomerleau P, Smith K, Stone JA, Wolfe DL. The development of evidence-informed physical activity guidelines for adults with spinal cord injury. Spinal Cord. 2011 Nov;49(11):1088-96. doi: 10.1038/sc.2011.63. Epub 2011 Jun 7.
PMID: 21647164
citation: Martin Ginis KA, Phang SH, Latimer AE, Arbour-Nicitopoulos KP. Reliability and validity tests of the leisure time physical activity questionnaire for people with spinal cord injury. Arch Phys Med Rehabil. 2012 Apr;93(4):677-82. doi: 10.1016/j.apmr.2011.11.005. Epub 2012 Feb 13.
PMID: 22336103
citation: Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
PMID: 3432232
citation: Scholz, U., Sniehotta, F. F., & Schwarzer, R. (2005). Predicting physical exercise in cardiac rehabilitation: The role of phase-specific self-efficacy beliefs. Journal of Sport and Exercise Psychology, 27(2), 135-151
citation: Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.
PMID: 21767036
citation: Sniehotta, F. F., Scholz, U., & Schwarzer, R. (2005). Bridging the intention-behaviour gap: Planning, self-efficacy, and action control in the adoption and maintenance of physical exercise. Psychology & Health, 20(2), 143-160. https://doi.org/10.1080/08870440512331317670
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Kathleen Martin Ginis
investigator title: Professor
mesh term: Spinal Cord Injuries
sharing ipd: No