<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/NCT04474171</url>
  </required_header>
  <id_info>
    <org_study_id>505419</org_study_id>
    <secondary_id>399095</secondary_id>
    <nct_id>NCT04474171</nct_id>
  </id_info>
  <brief_title>An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&amp;U</brief_title>
  <acronym>SCI&amp;U</acronym>
  <official_title>An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&amp;U</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</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>University of Toronto</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>
      Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury,&#xD;
      more than 50% of people discharged with a SCI may require re-hospitalization due to a&#xD;
      secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even&#xD;
      20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization&#xD;
      rates in Canada have remained high for more than 10 years, the length of stay in inpatient&#xD;
      rehabilitation has decreased dramatically, thereby limiting the time for provision of health&#xD;
      information and skill acquisition in the inpatient rehabilitation setting. There is growing&#xD;
      evidence from two recent pilot trials to suggest that self-management programs that provide&#xD;
      appropriate health information, skills and telephone-based support for community-dwelling&#xD;
      patients with SCI improves health behaviors and leads to reductions in re-hospitalization.&#xD;
&#xD;
      Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of&#xD;
      a definitive RCT to determine whether an online self-management program incorporating trained&#xD;
      peer health coaches (called &quot;SCI&amp;U&quot;) compared to usual care will result in improved&#xD;
      self-management skills (short-term outcome) and lead to reduced days of hospitalization&#xD;
      (long-term outcome) due to secondary complications.This pilot study is a two-group RCT with&#xD;
      an embedded qualitative component. The target population is adults with SCI who have been&#xD;
      discharged from inpatient rehabilitation and living in the community. Sixty subjects will be&#xD;
      recruited from across Canada with a focus on British Columbia and Ontario and randomly&#xD;
      assigned to the SCI&amp;U intervention or usual care.&#xD;
&#xD;
      Evaluations will occur at baseline, 2, 6, and 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Importance: Managing a spinal cord injury (SCI) is a life-long process. Within&#xD;
      the first year of injury, more than 50% of people discharged with a SCI may require&#xD;
      re-hospitalization due to a secondary complication, such as a urinary tract infection,&#xD;
      pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over&#xD;
      30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the&#xD;
      length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the&#xD;
      time for provision of health information and skill acquisition in the inpatient&#xD;
      rehabilitation setting. There is growing evidence from two recent pilot trials to suggest&#xD;
      that self-management programs that provide appropriate health information, skills and&#xD;
      telephone-based support for community-dwelling patients with SCI improves health behaviors&#xD;
      and leads to reductions in re-hospitalization.&#xD;
&#xD;
      Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of&#xD;
      a definitive RCT to determine whether an online self-management program incorporating trained&#xD;
      peer health coaches (called &quot;SCI&amp;U&quot;) compared to usual care will result in improved&#xD;
      self-management skills (short-term outcome) and lead to reduced days of hospitalization&#xD;
      (long-term outcome) due to secondary complications.&#xD;
&#xD;
      Secondary outcomes include self-efficacy for self-management, depression, resilience, number&#xD;
      and severity of secondary conditions, health-related quality of life, and patient-reported&#xD;
      unplanned ED visits.&#xD;
&#xD;
      Methods/Approaches/Expertise: This pilot study is a two-group RCT with an embedded&#xD;
      qualitative component. The target population is adults with SCI who have been discharged from&#xD;
      inpatient rehabilitation and living in the community. Sixty subjects will be recruited from&#xD;
      across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI&amp;U&#xD;
      intervention or usual care.&#xD;
&#xD;
      Evaluations will occur at 0, 2, 6, and 12 months. At 6 and 12 months, interviews will be&#xD;
      conducted with SCI&amp;U participants and at 12 months focus groups with health coaches, consumer&#xD;
      organizations, and rehabilitation hospital staff to explore the feasibility of the study&#xD;
      protocol, understand perceived costs and benefits of SCI&amp;U, and sustainability&#xD;
      considerations. The creation of the SCI&amp;U online self-management program is based on a number&#xD;
      of studies conducted by the research team. The investigators initially determined&#xD;
      implementation considerations in terms of need, content and mode of delivery in a mixed&#xD;
      methods study of individuals with SCI, their family members, and hospital managers. The SCI&amp;U&#xD;
      team includes rehabilitation researchers, persons with SCI, community-based organizations&#xD;
      (SCI BC, SCI Ontario and Praxis Spinal Cord Institute) and clinicians from across Canada. The&#xD;
      investigators used an integrated knowledge translation approach where users with SCI&#xD;
      co-designed and developed the prototype. The investigators have completed usability testing&#xD;
      on 20 participants and trained 5 health coaches and had an additional 11 individuals living&#xD;
      with SCI complete 6 sessions of health coaching using the SCI&amp;U prototype.&#xD;
&#xD;
      Expected Outcomes: The findings from this feasibility study are integral to the development&#xD;
      of a definitive RCT. It is anticipated that SCI&amp;U would not only reduce secondary&#xD;
      complications and subsequent inappropriate health care use, but also improve the quality of&#xD;
      life for individuals with SCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 16, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2021</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>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>It captures knowledge based skills and techniques that persons acquire to help them cope with health problems. It is a 4-point Likert scale (1-4) ranging from strongly disagree to strongly agree. Score is the sum of the 4 items. A higher score means a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Care Utilization: Cumulative days re-hospitalized 12 months after baseline</measure>
    <time_frame>12 months after baseline</time_frame>
    <description>Self-report of total days hospitalized for each participant will be obtained as the primary health care utilization outcome. This will be measured at 6 and 12 months after baseline with the qeustion &quot;how many total NIGHTS did you spend in the hospital in the past 6 months? A higher total number of days means a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Conditions Scale</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>This is a 16-item self report measure that targets secondary conditions associated with SCI that impact health. The response options are a 4-point scale (0 - not experienced in the last 3 months or is an insignificant problem, 1 mild or infrequent problem, 2 moderate or occasional problem, 3 significant or chronic problem. Score is the sum of the 16 items. A higher total score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>University of Washington Self-Efficacy Scale for People with Disabilities and Chronic Conditions: Short Form</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>6-item self-report questionnaire rating confidence in self-management skills on a 5-point Likert scale ranging from &quot;0&quot; not at all to '4&quot; completely. Score is the sum of the 6 items. A higher score means a better outcome (self-efficacy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Spinal Cord Injury Datasets Quality of Life Basic Dataset-Data Form (Version 1.0)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>3 questions from the International SCI QOL Basic dataset that rates satisfaction with general QOL, physical and psychological health on an 11-point Likert scale with &quot;0&quot; being completely dissatisfied&quot; to '10&quot; completely satisfied. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCI-QOL Resilience Short Form</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>8-item measure of adaptation or adjustment after the injury. The context for all resilience items is &quot;in the past 7 day...&quot;. The response options are a 5-point Likert scale ranging from &quot;1&quot; Never to &quot;5&quot; Always. Score is the sum of the 8 items. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal Health Questionnaire Depression Scale (PHQ-8)</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>8-item Likert scale measuring depression symptoms. Response options range from &quot;0&quot; not at all to &quot;3&quot; nearly every day. Score is the sum of the 8 items. A higher score means a worse outcome. A score of 10 or greater is considered major depression, 20 or more is severe major depression symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Emergency department visits</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>self-report number of emergency department visits in the past 6 months. The question is &quot;In the past 6 months, how many times did you go to a hospital emergency room?&quot; A higher number indicates more visits and means a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social/Role Activities Limitations</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>4-item self-report measure of limitations within the past 2 weeks. This is scored on a 5-point Likert scale with &quot;0&quot; as not at all and '4&quot; almost daily. The score of the scale is he mean of the four items. A higher scores indicates greater activities limitations.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>SCI&amp;U Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The SCI&amp;U online platform has a resource library, secure videoconferencing, and tools to support one-on-one health coaching. Health coaches are certified in motivational interviewing and have lived in the community with SCI for more than five years. In the first session, participants identify priority issues related to their health and target management of secondary conditions specific to SCI. They will work through goal setting, problem solving activities and create action plans for behaviour change, which will be securely stored. The intervention will be a maximum of 14 sessions over 6 months. Each session will cover a health-related topic (bladder, bowel, skin, pain, healthy eating, physical activity or stress, anxiety and depression) and a self-management skill topic (action planning, goal setting, problem-solving, mood management, navigating the health care system and communicating with health care providers) with an expected duration of 30 to 45 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual health care and be offered the SCI&amp;U program at the end of the 12-month follow-up period (wait-list control)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCI&amp;U online health coaching program</intervention_name>
    <description>Online secure videoconferencing health coaching platform with resource library to promote self-management. Maximum number of sessions is 14 over 6 months and covers health related topics to reduce secondary complications</description>
    <arm_group_label>SCI&amp;U Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 6 months post-injury to allow time to adjust to injury;&#xD;
&#xD;
          2. living in the community;&#xD;
&#xD;
          3. age ≥18 years;&#xD;
&#xD;
          4. ability to speak and read English and&#xD;
&#xD;
          5. have a primary care physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. currently participating in another formal self-management program and&#xD;
&#xD;
          2. self-report of physician diagnosed concurrent traumatic brain injury&#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>Susan B Jaglal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Susan B Jaglal, PhD</last_name>
    <phone>416 946-3941</phone>
    <email>susan.jaglal@utoronto.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sonya Allin, PhD</last_name>
    <email>s.allin@utoronto.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Jaglal, PhD</last_name>
      <phone>416 946-3941</phone>
      <email>susan.jaglal@utoronto.ca</email>
    </contact>
    <contact_backup>
      <last_name>Sonya Allin, PhD</last_name>
      <email>s.allin@utoronto.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://sci-and-u.ca</url>
    <description>study website</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Susan Jaglal</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>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>aggregated data from descriptive and outcomes measures will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>after publication of main study manuscript and for 5 years</ipd_time_frame>
    <ipd_access_criteria>need permission from PI</ipd_access_criteria>
  </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/NCT04474171
org study id: 505419
secondary id: 399095
nct id: NCT04474171
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury,
      more than 50% of people discharged with a SCI may require re-hospitalization due to a
      secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even
      20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization
      rates in Canada have remained high for more than 10 years, the length of stay in inpatient
      rehabilitation has decreased dramatically, thereby limiting the time for provision of health
      information and skill acquisition in the inpatient rehabilitation setting. There is growing
      evidence from two recent pilot trials to suggest that self-management programs that provide
      appropriate health information, skills and telephone-based support for community-dwelling
      patients with SCI improves health behaviors and leads to reductions in re-hospitalization.

      Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of
      a definitive RCT to determine whether an online self-management program incorporating trained
      peer health coaches (called "SCI&U") compared to usual care will result in improved
      self-management skills (short-term outcome) and lead to reduced days of hospitalization
      (long-term outcome) due to secondary complications.This pilot study is a two-group RCT with
      an embedded qualitative component. The target population is adults with SCI who have been
      discharged from inpatient rehabilitation and living in the community. Sixty subjects will be
      recruited from across Canada with a focus on British Columbia and Ontario and randomly
      assigned to the SCI&U intervention or usual care.

      Evaluations will occur at baseline, 2, 6, and 12 months.
Background and Importance: Managing a spinal cord injury (SCI) is a life-long process. Within
      the first year of injury, more than 50% of people discharged with a SCI may require
      re-hospitalization due to a secondary complication, such as a urinary tract infection,
      pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over
      30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the
      length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the
      time for provision of health information and skill acquisition in the inpatient
      rehabilitation setting. There is growing evidence from two recent pilot trials to suggest
      that self-management programs that provide appropriate health information, skills and
      telephone-based support for community-dwelling patients with SCI improves health behaviors
      and leads to reductions in re-hospitalization.

      Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of
      a definitive RCT to determine whether an online self-management program incorporating trained
      peer health coaches (called "SCI&U") compared to usual care will result in improved
      self-management skills (short-term outcome) and lead to reduced days of hospitalization
      (long-term outcome) due to secondary complications.

      Secondary outcomes include self-efficacy for self-management, depression, resilience, number
      and severity of secondary conditions, health-related quality of life, and patient-reported
      unplanned ED visits.

      Methods/Approaches/Expertise: This pilot study is a two-group RCT with an embedded
      qualitative component. The target population is adults with SCI who have been discharged from
      inpatient rehabilitation and living in the community. Sixty subjects will be recruited from
      across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI&U
      intervention or usual care.

      Evaluations will occur at 0, 2, 6, and 12 months. At 6 and 12 months, interviews will be
      conducted with SCI&U participants and at 12 months focus groups with health coaches, consumer
      organizations, and rehabilitation hospital staff to explore the feasibility of the study
      protocol, understand perceived costs and benefits of SCI&U, and sustainability
      considerations. The creation of the SCI&U online self-management program is based on a number
      of studies conducted by the research team. The investigators initially determined
      implementation considerations in terms of need, content and mode of delivery in a mixed
      methods study of individuals with SCI, their family members, and hospital managers. The SCI&U
      team includes rehabilitation researchers, persons with SCI, community-based organizations
      (SCI BC, SCI Ontario and Praxis Spinal Cord Institute) and clinicians from across Canada. The
      investigators used an integrated knowledge translation approach where users with SCI
      co-designed and developed the prototype. The investigators have completed usability testing
      on 20 participants and trained 5 health coaches and had an additional 11 individuals living
      with SCI complete 6 sessions of health coaching using the SCI&U prototype.

      Expected Outcomes: The findings from this feasibility study are integral to the development
      of a definitive RCT. It is anticipated that SCI&U would not only reduce secondary
      complications and subsequent inappropriate health care use, but also improve the quality of
      life for individuals with SCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire
time frame: 6 months after baseline
description: It captures knowledge based skills and techniques that persons acquire to help them cope with health problems. It is a 4-point Likert scale (1-4) ranging from strongly disagree to strongly agree. Score is the sum of the 4 items. A higher score means a better outcome.
measure: Health Care Utilization: Cumulative days re-hospitalized 12 months after baseline
time frame: 12 months after baseline
description: Self-report of total days hospitalized for each participant will be obtained as the primary health care utilization outcome. This will be measured at 6 and 12 months after baseline with the qeustion "how many total NIGHTS did you spend in the hospital in the past 6 months? A higher total number of days means a worse outcome.
measure: Secondary Conditions Scale
time frame: 6 months after baseline
description: This is a 16-item self report measure that targets secondary conditions associated with SCI that impact health. The response options are a 4-point scale (0 - not experienced in the last 3 months or is an insignificant problem, 1 mild or infrequent problem, 2 moderate or occasional problem, 3 significant or chronic problem. Score is the sum of the 16 items. A higher total score means a worse outcome.
measure: University of Washington Self-Efficacy Scale for People with Disabilities and Chronic Conditions: Short Form
time frame: 6 months after baseline
description: 6-item self-report questionnaire rating confidence in self-management skills on a 5-point Likert scale ranging from "0" not at all to '4" completely. Score is the sum of the 6 items. A higher score means a better outcome (self-efficacy).
measure: International Spinal Cord Injury Datasets Quality of Life Basic Dataset-Data Form (Version 1.0)
time frame: 6 months after baseline
description: 3 questions from the International SCI QOL Basic dataset that rates satisfaction with general QOL, physical and psychological health on an 11-point Likert scale with "0" being completely dissatisfied" to '10" completely satisfied. A higher score means a better outcome.
measure: SCI-QOL Resilience Short Form
time frame: 6 months after baseline
description: 8-item measure of adaptation or adjustment after the injury. The context for all resilience items is "in the past 7 day...". The response options are a 5-point Likert scale ranging from "1" Never to "5" Always. Score is the sum of the 8 items. A higher score means a better outcome.
measure: Personal Health Questionnaire Depression Scale (PHQ-8)
time frame: 6 months after baseline
description: 8-item Likert scale measuring depression symptoms. Response options range from "0" not at all to "3" nearly every day. Score is the sum of the 8 items. A higher score means a worse outcome. A score of 10 or greater is considered major depression, 20 or more is severe major depression symptoms.
measure: Self-reported Emergency department visits
time frame: 6 and 12 months
description: self-report number of emergency department visits in the past 6 months. The question is "In the past 6 months, how many times did you go to a hospital emergency room?" A higher number indicates more visits and means a worse outcome
measure: Social/Role Activities Limitations
time frame: 6 months after baseline
description: 4-item self-report measure of limitations within the past 2 weeks. This is scored on a 5-point Likert scale with "0" as not at all and '4" almost daily. The score of the scale is he mean of the four items. A higher scores indicates greater activities limitations.
arm group label: SCI&U Intervention
arm group type: Experimental
description: The SCI&U online platform has a resource library, secure videoconferencing, and tools to support one-on-one health coaching. Health coaches are certified in motivational interviewing and have lived in the community with SCI for more than five years. In the first session, participants identify priority issues related to their health and target management of secondary conditions specific to SCI. They will work through goal setting, problem solving activities and create action plans for behaviour change, which will be securely stored. The intervention will be a maximum of 14 sessions over 6 months. Each session will cover a health-related topic (bladder, bowel, skin, pain, healthy eating, physical activity or stress, anxiety and depression) and a self-management skill topic (action planning, goal setting, problem-solving, mood management, navigating the health care system and communicating with health care providers) with an expected duration of 30 to 45 minutes.
arm group label: Waitlist Control
arm group type: No Intervention
description: Usual health care and be offered the SCI&U program at the end of the 12-month follow-up period (wait-list control)
intervention type: Behavioral
intervention name: SCI&U online health coaching program
description: Online secure videoconferencing health coaching platform with resource library to promote self-management. Maximum number of sessions is 14 over 6 months and covers health related topics to reduce secondary complications
arm group label: SCI&U Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan B Jaglal, PhD
role: Principal Investigator
affiliation: Professor
last name: Susan B Jaglal, PhD
phone: 416 946-3941
email: susan.jaglal@utoronto.ca
last name: Sonya Allin, PhD
email: s.allin@utoronto.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
url: http://sci-and-u.ca
description: study website
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Susan Jaglal
investigator title: Professor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: aggregated data from descriptive and outcomes measures will be shared
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: after publication of main study manuscript and for 5 years
ipd access criteria: need permission from PI