<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/NCT04422769</url>
  </required_header>
  <id_info>
    <org_study_id>202005026</org_study_id>
    <nct_id>NCT04422769</nct_id>
  </id_info>
  <brief_title>Needs of Persons With Spinal Cord Injury (SCI)</brief_title>
  <official_title>Tracking Needs of Persons With a Spinal Cord Injury (SCI) During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
      Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and&#xD;
      poorer health outcomes than persons without spinal cord injury (SCI). They often experience a&#xD;
      great deal of health needs both on a physiological level as well as a psychosocial level.&#xD;
      PwSCI frequently require supports and services to be able to live independently within the&#xD;
      community. These services and supports are sometimes difficult to access within the community&#xD;
      when the country is operating under regular capacity, in current times with the global&#xD;
      COVID-19 pandemic, the challenges for obtaining and accessing supports and services will&#xD;
      become much greater. The proposed project aims to identify the specific needs during this&#xD;
      time of crisis and to provide referrals and resources to ameliorate those needs by surveying&#xD;
      PwSCI in the St. Louis region. The project also hopes to determine if these persons&#xD;
      experience isolation during shelter at home orders. PwSCI, who the investigators serve or&#xD;
      have served in the past, will be contacted via phone or e-mail once a month for six months&#xD;
      and asked to complete a questionnaire that will allow the investigators to track the&#xD;
      participant's needs during the COVID-19 pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acquiring a spinal cord injury (SCI) can be a traumatic event resulting in significant life&#xD;
      changes. Both the physical and psychosocial consequences of spinal cord injury may negatively&#xD;
      impact one's ability to accomplish activities of daily living, fully participate in&#xD;
      occupations, and fulfill social roles. People with SCI are at a greater risk for major health&#xD;
      conditions such as heart disease, high blood pressure, obesity, and diabetes than the&#xD;
      population without disabilities. Approximately 30% of individuals with SCI are also at risk&#xD;
      for developing negative mood states that include depression, anxiety, and anger. These&#xD;
      negative mood states can also increase the risk of poor health outcomes, including increased&#xD;
      medical complications, decreased independence in self-care, and decreased productivity.&#xD;
      People with SCI also often require a great deal of supports and services to live&#xD;
      independently within the community, such as a personal care attendant to assist with&#xD;
      activities of daily living, access to accessible transportation, access to medical care, and&#xD;
      access to repair services for their mobility device. Many of these supports and services are&#xD;
      difficult to obtain in the community, medical institutions, and businesses when everything is&#xD;
      operating in a regular capacity. With the changes in daily operations related to the COVID-19&#xD;
      pandemic there are many concerns about whether vulnerable populations like persons with SCI&#xD;
      will be able to access the supports and services they need, this project will give the&#xD;
      investigators information about what the needs are and whether they are being met.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NIH Toolbox Instrumental Support Survey - change in instrumental support</measure>
    <time_frame>Baseline, 3 month and 6 month</time_frame>
    <description>Instrumental Support refers to the perception that people in one's social network are available to provide material or functional aid in completing daily tasks (such as making meals or providing transportation) if needed. This self-report measure for adults (ages 18 and above) is an 8-item calibrated scale.This study will use the measure to determine if people's instrumental support changes during a pandemic.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>UCLA (University of California - Los Angeles) 3-item Loneliness Scale - change in social isolation</measure>
    <time_frame>Baseline, 3 month and 6 month</time_frame>
    <description>A scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each of the 3 items as hardly ever (score of &quot;1&quot;), some of the time (score of &quot;2&quot;), or often (score of &quot;3&quot;). The scores for each individual question can be added together to give you a possible range of scores from 3 to 9. The higher the score the more lonely the person will be. This study will use the measure to determine if people feel socially isolated during a pandemic.</description>
  </secondary_outcome>
  <enrollment type="Actual">53</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A sample of two hundred and fifty (n=250) persons with SCI will be recruited from the St.&#xD;
        Louis, MO community. Many of these persons will be those who have participated in some of&#xD;
        the investigators other research projects in the past. We also have collaborations with the&#xD;
        Washington University Seating and Mobility Clinic and Paraquad, the local center for&#xD;
        independent living.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of an SCI; are 18 years or older; live in the community in the Greater St.&#xD;
             Louis area, and have the ability to understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment that does not allow them to provide consent and/or ability to&#xD;
             understand the questions posed in the survey&#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>Kerri A Morgan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Adnana Y, Mckenzie A, Miyahara M. Self-efficacy for quad rugby skills and activities of daily living. Adapted Physical Activity Quarterly. 2001; 18: 90-101.</citation>
  </reference>
  <reference>
    <citation>Blauwet C, Willick SE. The Paralympic Movement: using sports to promote health, disability rights, and social integration for athletes with disabilities. PM R. 2012 Nov;4(11):851-6. doi: 10.1016/j.pmrj.2012.08.015.</citation>
    <PMID>23174549</PMID>
  </reference>
  <reference>
    <citation>Slater D, Meade MA. Participation in recreation and sports for persons with spinal cord injury: review and recommendations. NeuroRehabilitation. 2004;19(2):121-9.</citation>
    <PMID>15201471</PMID>
  </reference>
  <reference>
    <citation>U.S. Department of Health and Human Services. (2000). Healthy people 2010: Understanding and improving health. 2nd ed. Washington, DC: U.S. Government Printing Office.</citation>
  </reference>
  <reference>
    <citation>Jacobs PL, Beekhuizen KS. (2005). Appraisal of physiological fitness in persons with spinal cord injury. Topics in Spinal Cord Injury Rehabilitation, 10(4):32-50.</citation>
  </reference>
  <reference>
    <citation>Keyser RE, Rasch EK, Finley M, Rodgers MM. Improved upper-body endurance following a 12-week home exercise program for manual wheelchair users. J Rehabil Res Dev. 2003 Nov-Dec;40(6):501-10. doi: 10.1682/jrrd.2003.11.0501.</citation>
    <PMID>15077662</PMID>
  </reference>
  <reference>
    <citation>Post MW, van Leeuwen CM. Psychosocial issues in spinal cord injury: a review. Spinal Cord. 2012 May;50(5):382-9. doi: 10.1038/sc.2011.182. Epub 2012 Jan 24.</citation>
    <PMID>22270190</PMID>
  </reference>
  <reference>
    <citation>Middleton J, Tran Y, Craig A. Relationship between quality of life and self-efficacy in persons with spinal cord injuries. Arch Phys Med Rehabil. 2007 Dec;88(12):1643-8. doi: 10.1016/j.apmr.2007.09.001.</citation>
    <PMID>18047880</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 24, 2021</last_update_submitted>
  <last_update_submitted_qc>May 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Kerri Morgan</investigator_full_name>
    <investigator_title>Assistant Professor of Occupational Therapy and Neurology</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>
  <!-- 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/NCT04422769
org study id: 202005026
nct id: NCT04422769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and
      poorer health outcomes than persons without spinal cord injury (SCI). They often experience a
      great deal of health needs both on a physiological level as well as a psychosocial level.
      PwSCI frequently require supports and services to be able to live independently within the
      community. These services and supports are sometimes difficult to access within the community
      when the country is operating under regular capacity, in current times with the global
      COVID-19 pandemic, the challenges for obtaining and accessing supports and services will
      become much greater. The proposed project aims to identify the specific needs during this
      time of crisis and to provide referrals and resources to ameliorate those needs by surveying
      PwSCI in the St. Louis region. The project also hopes to determine if these persons
      experience isolation during shelter at home orders. PwSCI, who the investigators serve or
      have served in the past, will be contacted via phone or e-mail once a month for six months
      and asked to complete a questionnaire that will allow the investigators to track the
      participant's needs during the COVID-19 pandemic.
Acquiring a spinal cord injury (SCI) can be a traumatic event resulting in significant life
      changes. Both the physical and psychosocial consequences of spinal cord injury may negatively
      impact one's ability to accomplish activities of daily living, fully participate in
      occupations, and fulfill social roles. People with SCI are at a greater risk for major health
      conditions such as heart disease, high blood pressure, obesity, and diabetes than the
      population without disabilities. Approximately 30% of individuals with SCI are also at risk
      for developing negative mood states that include depression, anxiety, and anger. These
      negative mood states can also increase the risk of poor health outcomes, including increased
      medical complications, decreased independence in self-care, and decreased productivity.
      People with SCI also often require a great deal of supports and services to live
      independently within the community, such as a personal care attendant to assist with
      activities of daily living, access to accessible transportation, access to medical care, and
      access to repair services for their mobility device. Many of these supports and services are
      difficult to obtain in the community, medical institutions, and businesses when everything is
      operating in a regular capacity. With the changes in daily operations related to the COVID-19
      pandemic there are many concerns about whether vulnerable populations like persons with SCI
      will be able to access the supports and services they need, this project will give the
      investigators information about what the needs are and whether they are being met.
observational model: Cohort
time perspective: Prospective
measure: NIH Toolbox Instrumental Support Survey - change in instrumental support
time frame: Baseline, 3 month and 6 month
description: Instrumental Support refers to the perception that people in one's social network are available to provide material or functional aid in completing daily tasks (such as making meals or providing transportation) if needed. This self-report measure for adults (ages 18 and above) is an 8-item calibrated scale.This study will use the measure to determine if people's instrumental support changes during a pandemic.
measure: UCLA (University of California - Los Angeles) 3-item Loneliness Scale - change in social isolation
time frame: Baseline, 3 month and 6 month
description: A scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each of the 3 items as hardly ever (score of "1"), some of the time (score of "2"), or often (score of "3"). The scores for each individual question can be added together to give you a possible range of scores from 3 to 9. The higher the score the more lonely the person will be. This study will use the measure to determine if people feel socially isolated during a pandemic.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kerri A Morgan, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
citation: Adnana Y, Mckenzie A, Miyahara M. Self-efficacy for quad rugby skills and activities of daily living. Adapted Physical Activity Quarterly. 2001; 18: 90-101.
citation: Blauwet C, Willick SE. The Paralympic Movement: using sports to promote health, disability rights, and social integration for athletes with disabilities. PM R. 2012 Nov;4(11):851-6. doi: 10.1016/j.pmrj.2012.08.015.
PMID: 23174549
citation: Slater D, Meade MA. Participation in recreation and sports for persons with spinal cord injury: review and recommendations. NeuroRehabilitation. 2004;19(2):121-9.
PMID: 15201471
citation: U.S. Department of Health and Human Services. (2000). Healthy people 2010: Understanding and improving health. 2nd ed. Washington, DC: U.S. Government Printing Office.
citation: Jacobs PL, Beekhuizen KS. (2005). Appraisal of physiological fitness in persons with spinal cord injury. Topics in Spinal Cord Injury Rehabilitation, 10(4):32-50.
citation: Keyser RE, Rasch EK, Finley M, Rodgers MM. Improved upper-body endurance following a 12-week home exercise program for manual wheelchair users. J Rehabil Res Dev. 2003 Nov-Dec;40(6):501-10. doi: 10.1682/jrrd.2003.11.0501.
PMID: 15077662
citation: Post MW, van Leeuwen CM. Psychosocial issues in spinal cord injury: a review. Spinal Cord. 2012 May;50(5):382-9. doi: 10.1038/sc.2011.182. Epub 2012 Jan 24.
PMID: 22270190
citation: Middleton J, Tran Y, Craig A. Relationship between quality of life and self-efficacy in persons with spinal cord injuries. Arch Phys Med Rehabil. 2007 Dec;88(12):1643-8. doi: 10.1016/j.apmr.2007.09.001.
PMID: 18047880
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Kerri Morgan
investigator title: Assistant Professor of Occupational Therapy and Neurology
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries