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Needs of Persons With Spinal Cord Injury (SCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422769
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Kerri Morgan, Washington University School of Medicine

Brief Summary:
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.

Condition or disease
Spinal Cord Injuries

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tracking Needs of Persons With a Spinal Cord Injury (SCI) During the COVID-19 Pandemic
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. NIH Toolbox Instrumental Support Survey - change in instrumental support [ Time Frame: Baseline, 3 month and 6 month ]
    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.


Secondary Outcome Measures :
  1. UCLA (University of California - Los Angeles) 3-item Loneliness Scale - change in social isolation [ Time Frame: Baseline, 3 month and 6 month ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A sample of two hundred and fifty (n=250) persons with SCI will be recruited from the St. Louis, MO community. Many of these persons will be those who have participated in some of the investigators other research projects in the past. We also have collaborations with the Washington University Seating and Mobility Clinic and Paraquad, the local center for independent living.
Criteria

Inclusion Criteria:

  • diagnosis of an SCI; are 18 years or older; live in the community in the Greater St. Louis area, and have the ability to understand English.

Exclusion Criteria:

  • cognitive impairment that does not allow them to provide consent and/or ability to understand the questions posed in the survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422769


Contacts
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Contact: Kimberly A Walker, OTD 314-273-7010 walker.k@wustl.edu
Contact: Kerri A Morgan, PhD 314-286-1659 morgank@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Kimberly A Walker, OTD    314-273-7010    walker.k@wustl.edu   
Contact: Kerri A Morgan, PhD    314-286-1659    morgank@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Kerri A Morgan, PhD Washington University School of Medicine
Publications:
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Responsible Party: Kerri Morgan, Assistant Professor of Occupational Therapy and Neurology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04422769    
Other Study ID Numbers: 202005026
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System