Spinal Cord InjuriesNCT03437850
Strengthening Health Systems for Persons With Traumatic Spinal Cord Injury in South Africa and Sweden
An observational study of Spinal Cord Injuries, run by University of the Western Cape at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 200 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Apr 2017to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All newly-injured individuals with traumatic spinal cord injury for at least a one-year period within a defined catchment area.
Who may be able to join
- 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;
- 18 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
University of the Western Cape
Cape Town
Conran Joseph, PhD, +27723719276, cjoseph@uwc.ac.za
About this study
Official title: Strengthening Health Systems for Persons With Traumatic Spinal Cord Injury in South Africa and Sweden: a Protocol for a Longitudinal Study of Processes and Outcomes
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.
Read the detailed description
Like many unforeseen medical emergencies, a TSCI could lead to early death in the absence of essential emergency and acute care. Hence, the single most important indicator of the quality of medical care is reflected in short- and long-term mortality. However, in order to improve survival after TSCI, it is also important to identify factors and processes of routine practice related to mortality. This could be accomplished by examining the extent to which processes of care reflect international guidelines and standards. These guidelines specifically stress the importance of a systematic approach towards the management of TSCI, which include specialized and comprehensive care that is delivered in a multi-disciplinary manner. More specifically, established success factors of TSCI healthcare have proven to include appropriate emergency management (e.g. transfer logistics to trauma unit), early spinal surgery and admission to specialist units, as well as multidisciplinary care. As a collective, literature has shown that a systematic approach towards the management of TSCI leads to a reduction in mortality, secondary complications and re-hospitalizations, as well as better functional outcomes.
In Sweden, a systematic approach towards the management of TSCI was initiated around the 1970's. A number of studies investigating the acute management and mortality after TSCI found better aligned processes of care, and significantly greater survival, in Sweden, compared with a non-systematic approach to care followed in Greece. More specifically, transfer logistics from the accident scene to a specialized trauma unit, key therapeutic interventions, and timing of spinal surgery were better aligned to the international guidelines for the acute management of adults with SCI. In addition, numerous societal services, such as vocational rehabilitation, modifications of living conditions and workplace insurance, are provided to survivors of TSCI to enhance their independence and societal participation.
Unlike Sweden, South Africa had yet to fully implement a systematic healthcare approach to TSCI management. Access to specialized healthcare services is not only a historic problem in South Africa, but it is further exacerbated by the lack of resources. Only one specialized SCI unit is available in South Africa, serving around 8 million people in the Western Cape Province. With the high incidence of TSCI in South Africa, mainly high risk TSCI patients (e.g. those in need of stabilizing spinal surgery) get access to specialized care at the SCI unit. In contrast, those not prioritized for treatment at the specialized SCI unit are treated at hospitals, including both secondary and tertiary level of care, providing non-specialized SCI health care. The common occurrence of non-specialized care of TSCI survivors in South Africa is alarming, especially as such care has shown to be related to a high mortality rate and the occurrence of preventable secondary complications. To improve the outcome of TSCI in South Africa, there is a crucial need to audit the nature and timing of essential processes of care and model their relationship with mortality, complications and long-term outcomes. Furthermore, given the low one-year mortality in Sweden, a comparison of processes of care between Sweden and South Africa could provide empirical evidence pointing to processes which could be modified.
As a first step to strengthening the management guidelines for TSCI care in South Africa, the overarching aim of this study is to explore health-care processes and outcomes of TSCI care in South Africa and Sweden. Specific aims are to: 1) describe acute processes of TSCI care in South Africa and Sweden in comparison to international guidelines, 2) determine acute- and long-term outcomes of TSCI care, including survival status, secondary complications and functioning in South Africa and Sweden and 3) identify predictors for survival, secondary complications and functioning 12 months post-injury in South Africa and Sweden.
- Conditions
- Spinal Cord Injuries
- Being tested
- Usual care
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Care as usual, in terms of processes and outcomes, will be collected for all participants in both cohorts
| Study group | Role | What they receive |
|---|---|---|
| South African cohort | Not described Receives: Other: Usual care | |
| Swedish Cohort | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To determine the mortality rate at the end of acute care
Measured: 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
Measured: one year after injury
Prevalence of pressure ulcers
To determine the prevalence and grade of pressure ulcers during acute care
Measured: acute care prevalence (within a six-week period approximately)
Prevalence of pressure ulcers
To determine the prevalence of pressure ulcers one-year after injury
Measured: 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)
Measured: 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)
Measured: 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
Change in activity limitations according to Spinal Cord Independence Measure III
Measured: 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
Change in activity limitations from the end of acute care (baseline) to one-year after injury according to the Spinal Cord Independence Measure III
Measured: 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
Change in health-related quality of life from acute care admission to end of acute care hospitalisation using the EQ-5D measure
Measured: 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
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
Measured: one-year after injury onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Apr 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Western Cape
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, Karolinska Institutet, Karolinska University Hospital
- Responsible party
- Principal investigator, Dr Conran Joseph, University of the Western Cape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437850
- Sponsor's protocol ID
- BM/16/3/24
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Health Systems for Persons With Traumatic Spinal Cord Injury in South Africa and Sweden: a Protocol for a Longitudinal Study of Processes and Outcomes
- ClinicalTrials.gov ID
- NCT03437850
- Acronym / sponsor ID
- BM/16/3/24
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of the Western CapeUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, Karolinska Institutet, Karolinska University Hospital
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Like many unforeseen medical emergencies, a TSCI could lead to early death in the absence of essential emergency and acute care. Hence, the single most important indicator of the quality of medical care is reflected in short- and long-term mortality. However, in order to improve survival after TSCI, it is also important to identify factors and processes of routine practice related to mortality. This could be accomplished by examining the extent to which processes of care reflect international guidelines and standards. These guidelines specifically stress the importance of a systematic approach towards the management of TSCI, which include specialized and comprehensive care that is delivered in a multi-disciplinary manner. More specifically, established success factors of TSCI healthcare have proven to include appropriate emergency management (e.g. transfer logistics to trauma unit), early spinal surgery and admission to specialist units, as well as multidisciplinary care. As a collective, literature has shown that a systematic approach towards the management of TSCI leads to a reduction in mortality, secondary complications and re-hospitalizations, as well as better functional outcomes.
In Sweden, a systematic approach towards the management of TSCI was initiated around the 1970's. A number of studies investigating the acute management and mortality after TSCI found better aligned processes of care, and significantly greater survival, in Sweden, compared with a non-systematic approach to care followed in Greece. More specifically, transfer logistics from the accident scene to a specialized trauma unit, key therapeutic interventions, and timing of spinal surgery were better aligned to the international guidelines for the acute management of adults with SCI. In addition, numerous societal services, such as vocational rehabilitation, modifications of living conditions and workplace insurance, are provided to survivors of TSCI to enhance their independence and societal participation.
Unlike Sweden, South Africa had yet to fully implement a systematic healthcare approach to TSCI management. Access to specialized healthcare services is not only a historic problem in South Africa, but it is further exacerbated by the lack of resources. Only one specialized SCI unit is available in South Africa, serving around 8 million people in the Western Cape Province. With the high incidence of TSCI in South Africa, mainly high risk TSCI patients (e.g. those in need of stabilizing spinal surgery) get access to specialized care at the SCI unit. In contrast, those not prioritized for treatment at the specialized SCI unit are treated at hospitals, including both secondary and tertiary level of care, providing non-specialized SCI health care. The common occurrence of non-specialized care of TSCI survivors in South Africa is alarming, especially as such care has shown to be related to a high mortality rate and the occurrence of preventable secondary complications. To improve the outcome of TSCI in South Africa, there is a crucial need to audit the nature and timing of essential processes of care and model their relationship with mortality, complications and long-term outcomes. Furthermore, given the low one-year mortality in Sweden, a comparison of processes of care between Sweden and South Africa could provide empirical evidence pointing to processes which could be modified.
As a first step to strengthening the management guidelines for TSCI care in South Africa, the overarching aim of this study is to explore health-care processes and outcomes of TSCI care in South Africa and Sweden. Specific aims are to: 1) describe acute processes of TSCI care in South Africa and Sweden in comparison to international guidelines, 2) determine acute- and long-term outcomes of TSCI care, including survival status, secondary complications and functioning in South Africa and Sweden and 3) identify predictors for survival, secondary complications and functioning 12 months post-injury in South Africa and Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| South African cohort | – | Other: Usual care |
| Swedish Cohort | – | Other: Usual care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All newly-injured individuals with traumatic spinal cord injury for at least a one-year period within a defined catchment area.
Key inclusion criteria (7 listed)
- 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;
- 18 years of age;
- Residents of one of the two study settings;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careCare as usual, in terms of processes and outcomes, will be collected for all participants in both cohorts | Other | South African cohort, Swedish Cohort |
Primary outcome
Mortality
Time frame: at the end of acute hospital care (approximately six weeks from admission)
To determine the mortality rate at the end of acute care
One-year mortality
Time frame: one year after injury
To determine the mortality rate after traumatic spinal cord injury one-year after injury onset
Prevalence of pressure ulcers
Time frame: acute care prevalence (within a six-week period approximately)
To determine the prevalence and grade of pressure ulcers during acute care
Prevalence of pressure ulcers
Time frame: One year after injury onset
To determine the prevalence of pressure ulcers one-year after injury
Change in neurological classification from baseline to the end of acute care according to the American Spinal Injury Association Impairment Scale
Time frame: End of acute care (within a six-week period approximately)
Neurological status using the ASIA scale (A-E)
Change in neurological classification from the end of acute care to one-year after injury according to the American Spinal Injury Association Impairment Scale
Time frame: One year after injury onset
Neurological status using the ASIA scale (A-E)
4 secondary outcomes
Change in activity limitations from acute care admission to end of acute admission according to the Spinal Cord Independence Measure III
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: one-year after injury onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: Undecided. May be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of the Western Cape at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conran Joseph, PhD (+27723719276, cjoseph@uwc.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: at the end of acute hospital care (approximately six weeks from admission)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.