Strengthening Health Systems for Persons With Traumatic Spinal Cord Injury in South Africa and Sweden

NCT03437850 | Unknown

• 1 other identifier: BM/16/3/24
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A traumatic spinal cord injury (TSCI) often causes an unprecedented change in functioning by altering bodily structure and function. More specifically, the direct consequences of TSCI to the motor, sensory and autonomic nervous system not only challenge an individual's independency but also the ability to make a positive adjustment to life after injury. In line with this, TSCI survivors often experience threats to their livelihood and becoming integrated members of society. Health systems therefore need to be ready to respond to the myriad of challenges following a TSCI by providing access to specialized and comprehensive services. The provision of specialized care in a time-sensitive manner has shown to be crucial for survival and recovery of functioning after a traumatic spinal cord injury (TSCI). However, little is known about the provision of TSCI care in different international contexts; information which is required for strengthening policy and practice.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (6)

• Mortality

  To determine the mortality rate at the end of acute care

  at the end of acute hospital care (approximately six weeks from admission)

• One-year mortality

  To determine the mortality rate after traumatic spinal cord injury one-year after injury onset

  one year after injury

• Prevalence of pressure ulcers

  To determine the prevalence and grade of pressure ulcers during acute care

  acute care prevalence (within a six-week period approximately)

• Prevalence of pressure ulcers

  To determine the prevalence of pressure ulcers one-year after injury

  One year after injury onset

• Change in neurological classification from baseline to the end of acute care according to the American Spinal Injury Association Impairment Scale

  Neurological status using the ASIA scale (A-E)

  End of acute care (within a six-week period approximately)

• Change in neurological classification from the end of acute care to one-year after injury according to the American Spinal Injury Association Impairment Scale

  Neurological status using the ASIA scale (A-E)

  One year after injury onset

Secondary Outcomes (4)

• Change in activity limitations from acute care admission to end of acute admission according to the Spinal Cord Independence Measure III

  After acute care (approximately 6 weeks post injury)

• Change in activity limitations from the end of acute care to one-year after injury according to the Spinal Cord Independence Measure III

  One-year after injury onset

• Change in health-related quality of life from acute care admission to end of acute care hospitalisation using the EQ-5D measure

  At the end of acute care (approximately six weeks)

• Change in health-related quality of life between the end of acute care hospitalisation and one-year after injury onset using the EQ-5D measure

  one-year after injury onset

Study Arms (2)

South African cohort

Other: Usual care

Swedish Cohort

Other: Usual care

Interventions

Usual care OTHER

Care as usual, in terms of processes and outcomes, will be collected for all participants in both cohorts

South African cohort; Swedish Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All newly-injured individuals with traumatic spinal cord injury for at least a one-year period within a defined catchment area.

You may qualify if:

• A TSCI defined as a sudden loss of voluntary muscle strength, sensation and autonomic functions below the level of injury, which will vary depending on neurological level of injury and extent of impairment, but must include altered sacral sensation;
• The injury must result in persisting impairment (i.e. not just a concussion) after emergence from neurogenic shock, which generally occurs within the first 24-72 hours after injury;
• Abnormal imaging, such as with Magnetic Resonance Imaging scan or multi-slice Computed Tomography scan;
• years of age;
• Residents of one of the two study settings;
• Those admitted to the government-funded hospitals providing SCI care;
• Those consenting to participate in the study

Sponsors & Collaborators

• University of the Western Cape: lead
• Medical Research Council, South Africa: collaborator
• Karolinska Institutet: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

University of the Western Cape

Cape Town, South Africa

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Conran Joseph, PhD

CONTACT

+27723719276; cjoseph@uwc.ac.za

Anthea Rhoda, PhD

CONTACT

+27219592542; arhoda@uwc.ac.za

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer (PhD)

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: April 15, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

ZA (1)