Spinal Cord InjuryNCT02582619
Multidisciplinary Model to Guide Employment Amongst PLWSCI
An observational study of Spinal Cord Injury, run by University of KwaZulu at 3 sites in South Africa.
Trial summary
Spinal cord injury often results in complete or partial loss of functioning of the upper and or lower limbs, leading to the affected individual experiencing difficulties in performing activities of daily living. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Focus groups, semistructured interviews and Delphi rounds
- How many people
- 180 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Oct 2015to Aug 2021
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Phase One : Rehabilitation Professionals People living with Spinal Cord Injuries Representatives from various working environment
Who may be able to join
- Rehabilitation professionals who are directly involved in the management of individuals who sustain SCI and have more than 1 year of working experience post community service.
- Person who sustained injury to the spine, resulting in permanent neurological damage (complete or incomplete) and must reside in a rural, peri-urban and urban.
Who cannot join
- Rehabilitation professionals who are not directly involved in the management of individuals who sustain SCI and have less than 1 year working experience post community service.
- Phase Two :
- People living with spinal cord injuries who cannot verbally communicate
- Phase Three Inclusion Criteria
- PLWSCI Injury to who resides in a rural, peri-urban and urban.
- Rehabilitation professionals who are directly involved in the management of individuals who sustain SCI and have more than 2 years of experience post community service.
Show all 11Show fewer
- An individual who is full time employed in a supervisory and managerial capacity in both private and public sector, currently have subordinates who are PLWSCI.
- A representative from the Disability Section of an insurance company that is the member of the LOA.
- PLWSCI who cannot verbally communicate.
- Rehabilitation professionals who are not directly involved in the management of individuals who sustain SCI and have less than two years of experience post community service.
- An individual who is employed on a part-time basis and not in supervisory or managerial positions and have no subordinates who are PLWSCI.
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
King Dinizulu Hospital
Durban, KwaZulu-Natal, 4000
Phoenix Spinal Rehabilitation Centre
Durban, KwaZulu-Natal, 4068
Greys Hospital
Pietermaritzburg, KwaZulu-Natal, 3200
About this study
Official title: Development of a Multidisciplinary Model to Guide Employment Outcomes in People Living With Spinal Cord Injuries in South Africa.
Spinal cord injury often results in complete or partial loss of functioning of the upper and or lower limbs, leading to the affected individual experiencing difficulties in performing activities of daily living. This in turn results in reduced participation in social, religious, recreational and economic activities (employment). Globally, there is a low employment rate (11-67%) amongst PLWSCI. In South Africa, according to Statistics South Africa, the unemployment rate of people with disabilities is estimated to be 25.2%. However, there is no information available on employment amongst PLWSCI in South Africa.
Furthermore, there is insufficient knowledge related to SCI in South Africa to enable a model to be developed and implemented. Data on the current SCI rehabilitation practices (with specific reference to vocational rehabilitation); employment status and factors (both personal and environmental); barriers and facilitators of employment amongst PLWSCI is limited. This information is needed to develop a return to work model for individuals with SCI in South Africa.
In South Africa, a legal framework exists that promotes the employment as well as assistance of people with disabilities in the workplace, such as: the Constitution of Republic of South Africa, 1996; the Employment Equity Act (EEA), 1998; the Promotion of Equality and Prevention of Unfair Discrimination Act (PEPUDA), 2000; Labour Relations Act (LRA), 1995; Skills Development Act (SDA), 1998; Public Service Act (PSA), 1994; Basic Conditions of Employment Act (BCEA), 1997 and the Integrated National Disability Strategy (2000). However, rehabilitation interventions provided in rehabilitation institutions are mainly medical, with limited attempts to prepare those with SCI to return to gainful employment. There is therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in South Africa.
Read the detailed description
This is a cross-sectional study in which mixed methods will be used in various phases of the study. Mixed methods involve the collection and analysis of both quantitative and qualitative data in a single study. Data are collected concurrently or sequentially and integrated at one or more stages during the research process. This study will be divided into 3 phases with stages to answer the objectives.
Phase one of this study will attempt to answer objectives 1-3 of the study. Stage 1 will include a systematic review of literature to identify the most effective vocational rehabilitation interventions amongst PLWSCI. Stage 2 will determine rehabilitation services rendered to individual who sustain SCI in South Africa with an intention of identifying gaps in vocational rehabilitation practices by retrospectively analysing medical files. This phase will be concluded by a focus group to further explore current vocational rehabilitation practices rendered to PLWSCI (Stage3).
Phase two will answer objectives 4-5. Stage 1 of this phase will determine the employment status as well as factors that influence employment amongst PLWSCI. Stage 2 will determine the barriers and facilitators of employment amongst PLWSCI. Results obtained from phase 1 to 2, will be utilised to by the researcher to develop the proposed model.
The final phase will aim to develop, validate and refine the model. Stage 1 of this phase will include the researcher using the information gained in previous phases to develop the proposed model. The second stage will include a focus group to validate the content of the proposed model. The last stage will included obtaining consensus amongst the stakeholders regarding the structure and the content of the proposed model and subsequently refine it.
- Conditions
- Spinal Cord Injury
- Being tested
- Focus groups, semistructured interviews and Delphi rounds
- Keywords
- Spinal Cord Injury and Employment
- 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.
Focus groups, semistructured interviews and Delphi roundsOther
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Professionals | Focus group consisting of rehabilitation professionals that will inform the study on vocational rehabilitation interventions rendered during acute to in-patient rehabilitation in KwaZulu-Natal. Receives: Other: Focus groups, semistructured interviews and Delphi rounds | |
| People living with Spinal Cord Injuries (PLWSCI) | Focus group consisting of PLWSCI that will inform the study on the perspective of the patient on vocational rehabilitation needs or desires during acute care and in-patient rehabilitation.
This group will inform the study on the employment rate amongst people living with spinal cord injuries as well as factors that influence employment.
This group will also inform the study on the perceived barriers and facilitators of employment Receives: Other: Focus groups, semistructured interviews and Delphi rounds | |
| Stakeholders | Representatives from the following departments or organisations will be invited to participate in the interviews and focus groups:
Government Departments:
Education Social Development Health Labour Transport
Private Companies:
Insurance Companies and Health Risk Management companies Non-profit Organisations QASA DPSA Receives: Other: Focus groups, semistructured interviews and Delphi rounds | |
| Experts | A delphi technique will be used to get an expert opinion and consensus on the aspects of the model to be developed. Receives: Other: Focus groups, semistructured interviews and Delphi rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
A multidisciplinary model to guide employment amongst people living with spinal cord injuries
The final model will be developed using all the information gained from the Phase one and two of the study. A validation process will be done through the delphi rounds.
Measured: 18 months
Secondary outcomes (4)
Systematic Review of effective Vocational Rehabilitation interventions amongst People Living With Spinal Cord Injuries
The review study will follow the Chocrane A journal article will be published in a peer reviewed journal.
Measured: Five Months
Rehabilitation Practices that promote employability of People Living with Spinal Cord Injuries
Stage 2 and Stage Three of Phase one will develop a matrix or guideline of vocational rehabilitation interventions throughout the phases of rehabilitation.
Measured: Three months
Employment and Factors that affect employment amongst People living with Spinal Cord Injuries
Employment rates and nature of employment will be quantified using the International Labour Organisation definition of employment. The Factors affecting employment will also be quantified using the modified Life Situation Questionnaire.
Measured: Five months
Barriers and Facilitators of employment amongst people living with spinal cord injuries.
Interviews and focus groups will be conducted to determine the barriers and facilitators of employment amongst PLWSCI.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2019
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (72)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ntsikelelo Pefile, University of KwaZulu
- Investigators
- Ntsikelelo Pefile, MScMedSc, Principal investigator, University of KwaZulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582619
- Sponsor's protocol ID
- BE499/14
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2015
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson, D., Dumont, S., Azzaria, L., Le Bourdais, M., & Noreau, L. ( 2007). Determinants of return to work among spinal cord injury patients: A literature review. Journal of Vocational Rehabilitation , 27(1), 57-68.
Bromley, I. (2006). Tetraplegia and Paraplegia. Sixth ed. London: Churchill Livingstone Elsevier.
Catz A, Itzkovich M, Agranov E, Ring H, Tamir A. SCIM--spinal cord independence measure: a new disability scale for patients with spinal cord lesions. Spinal Cord. 1997 Dec;35(12):850-6. doi: 10.1038/sj.sc.3100504.
PubMed 9429264Chan SK, Man DW. Barriers to returning to work for people with spinal cord injuries: a focus group study. Work. 2005;25(4):325-32.
PubMed 16340109Coetzee, Z. G., C; van der Westhuizen, R; Van Niekerk, L. (2011). Re-conceptualising vocational rehabilitation services towards an inter-sectoral model. South African Journal of Occupational Therapy, 41(2), 32-36.
Department of Health (South Africa). (2000). National Rehabilitation Policy. Pretoria: Government Printer.
DeVivo M, Biering-Sorensen F, Charlifue S, Noonan V, Post M, Stripling T, Wing P; Executive Committee for the International SCI Data Sets Committees. International Spinal Cord Injury Core Data Set. Spinal Cord. 2006 Sep;44(9):535-40. doi: 10.1038/sj.sc.3101958.
PubMed 16955073DeVivo MJ, Biering-Sorensen F, New P, Chen Y; International Spinal Cord Injury Data Set. Standardization of data analysis and reporting of results from the International Spinal Cord Injury Core Data Set. Spinal Cord. 2011 May;49(5):596-9. doi: 10.1038/sc.2010.172. Epub 2010 Dec 7.
PubMed 21135863Dewbury,G., Clarke, K.,Randall, D., Rouncefield, M., Sommerville, I. (2004). The anti-social model of disability Disability and Society 19(2). 145-158.
Domholdt, E. (2005). Rehabilitation Research: Principles and Applications. Third ed. Missouri: Elsevier Saunders.
Dumont RJ, Okonkwo DO, Verma S, Hurlbert RJ, Boulos PT, Ellegala DB, Dumont AS. Acute spinal cord injury, part I: pathophysiologic mechanisms. Clin Neuropharmacol. 2001 Sep-Oct;24(5):254-64. doi: 10.1097/00002826-200109000-00002.
PubMed 11586110Ekong CE, Tator CH. Spinal cord injury in the work force. Can J Surg. 1985 Mar;28(2):165-7.
PubMed 3971241Escorpizo, R., Miller,W.C., Trenaman, L.M. (2012). Work and Employment Spinal Cord Rehabilitation Evidence, 4.0., 1-14.
Fielingsdorf K, Dunn RN. Cervical spine injury outcome--a review of 101 cases treated in a tertiary referral unit. S Afr Med J. 2007 Mar;97(3):203-7.
PubMed 17440669Gobelet C, Luthi F, Al-Khodairy AT, Chamberlain MA. Vocational rehabilitation: a multidisciplinary intervention. Disabil Rehabil. 2007 Sep 15;29(17):1405-10. doi: 10.1080/09638280701315060.
PubMed 17729086
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multidisciplinary Model to Guide Employment Outcomes in People Living With Spinal Cord Injuries in South Africa.
- ClinicalTrials.gov ID
- NCT02582619
- Acronym / sponsor ID
- BE499/14
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury and Employment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
Spinal cord injury often results in complete or partial loss of functioning of the upper and or lower limbs, leading to the affected individual experiencing difficulties in performing activities of daily living. This in turn results in reduced participation in social, religious, recreational and economic activities (employment). Globally, there is a low employment rate (11-67%) amongst PLWSCI. In South Africa, according to Statistics South Africa, the unemployment rate of people with disabilities is estimated to be 25.2%. However, there is no information available on employment amongst PLWSCI in South Africa.
Furthermore, there is insufficient knowledge related to SCI in South Africa to enable a model to be developed and implemented. Data on the current SCI rehabilitation practices (with specific reference to vocational rehabilitation); employment status and factors (both personal and environmental); barriers and facilitators of employment amongst PLWSCI is limited. This information is needed to develop a return to work model for individuals with SCI in South Africa.
In South Africa, a legal framework exists that promotes the employment as well as assistance of people with disabilities in the workplace, such as: the Constitution of Republic of South Africa, 1996; the Employment Equity Act (EEA), 1998; the Promotion of Equality and Prevention of Unfair Discrimination Act (PEPUDA), 2000; Labour Relations Act (LRA), 1995; Skills Development Act (SDA), 1998; Public Service Act (PSA), 1994; Basic Conditions of Employment Act (BCEA), 1997 and the Integrated National Disability Strategy (2000). However, rehabilitation interventions provided in rehabilitation institutions are mainly medical, with limited attempts to prepare those with SCI to return to gainful employment. There is therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in South Africa.
Detailed description
This is a cross-sectional study in which mixed methods will be used in various phases of the study. Mixed methods involve the collection and analysis of both quantitative and qualitative data in a single study. Data are collected concurrently or sequentially and integrated at one or more stages during the research process. This study will be divided into 3 phases with stages to answer the objectives.
Phase one of this study will attempt to answer objectives 1-3 of the study. Stage 1 will include a systematic review of literature to identify the most effective vocational rehabilitation interventions amongst PLWSCI. Stage 2 will determine rehabilitation services rendered to individual who sustain SCI in South Africa with an intention of identifying gaps in vocational rehabilitation practices by retrospectively analysing medical files. This phase will be concluded by a focus group to further explore current vocational rehabilitation practices rendered to PLWSCI (Stage3).
Phase two will answer objectives 4-5. Stage 1 of this phase will determine the employment status as well as factors that influence employment amongst PLWSCI. Stage 2 will determine the barriers and facilitators of employment amongst PLWSCI. Results obtained from phase 1 to 2, will be utilised to by the researcher to develop the proposed model.
The final phase will aim to develop, validate and refine the model. Stage 1 of this phase will include the researcher using the information gained in previous phases to develop the proposed model. The second stage will include a focus group to validate the content of the proposed model. The last stage will included obtaining consensus amongst the stakeholders regarding the structure and the content of the proposed model and subsequently refine it.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Professionals | – | Other: Focus groups, semistructured interviews and Delphi roundsFocus group consisting of rehabilitation professionals that will inform the study on vocational rehabilitation interventions rendered during acute to in-patient rehabilitation in KwaZulu-Natal. |
| People living with Spinal Cord Injuries (PLWSCI) | – | Other: Focus groups, semistructured interviews and Delphi roundsFocus group consisting of PLWSCI that will inform the study on the perspective of the patient on vocational rehabilitation needs or desires during acute care and in-patient rehabilitation. This group will inform the study on the employment rate amongst people living with spinal cord injuries as well as factors that influence employment. This group will also inform the study on the perceived barriers and facilitators of employment |
| Stakeholders | – | Other: Focus groups, semistructured interviews and Delphi roundsRepresentatives from the following departments or organisations will be invited to participate in the interviews and focus groups: Government Departments: Education Social Development Health Labour Transport Private Companies: Insurance Companies and Health Risk Management companies Non-profit Organisations QASA DPSA |
| Experts | – | Other: Focus groups, semistructured interviews and Delphi roundsA delphi technique will be used to get an expert opinion and consensus on the aspects of the model to be developed. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Phase One : Rehabilitation Professionals People living with Spinal Cord Injuries Representatives from various working environment
Key inclusion criteria (2 listed)
- Rehabilitation professionals who are directly involved in the management of individuals who sustain SCI and have more than 1 year of working experience post community service.
- Person who sustained injury to the spine, resulting in permanent neurological damage (complete or incomplete) and must reside in a rural, peri-urban and urban.
Key exclusion criteria (11 listed)
- Rehabilitation professionals who are not directly involved in the management of individuals who sustain SCI and have less than 1 year working experience post community service.
- People living with spinal cord injuries who cannot verbally communicate
- Phase Three Inclusion Criteria
- PLWSCI Injury to who resides in a rural, peri-urban and urban.
- Rehabilitation professionals who are directly involved in the management of individuals who sustain SCI and have more than 2 years of experience post community service.
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 |
|---|---|---|
| Focus groups, semistructured interviews and Delphi rounds | Other | Experts, People living with Spinal Cord Injuries (PLWSCI), Rehabilitation Professionals, Stakeholders |
Primary outcome
A multidisciplinary model to guide employment amongst people living with spinal cord injuries
Time frame: 18 months
The final model will be developed using all the information gained from the Phase one and two of the study. A validation process will be done through the delphi rounds.
4 secondary outcomes
Systematic Review of effective Vocational Rehabilitation interventions amongst People Living With Spinal Cord Injuries
Time frame: Five Months
Rehabilitation Practices that promote employability of People Living with Spinal Cord Injuries
Time frame: Three months
Employment and Factors that affect employment amongst People living with Spinal Cord Injuries
Time frame: Five months
Barriers and Facilitators of employment amongst people living with spinal cord injuries.
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- BackgroundAnderson, D., Dumont, S., Azzaria, L., Le Bourdais, M., & Noreau, L. ( 2007). Determinants of return to work among spinal cord injury patients: A literature review. Journal of Vocational Rehabilitation , 27(1), 57-68.
- BackgroundBromley, I. (2006). Tetraplegia and Paraplegia. Sixth ed. London: Churchill Livingstone Elsevier.
- Background: PubMed 9429264Catz A, Itzkovich M, Agranov E, Ring H, Tamir A. SCIM--spinal cord independence measure: a new disability scale for patients with spinal cord lesions. Spinal Cord. 1997 Dec;35(12):850-6. doi: 10.1038/sj.sc.3100504.
- Background: PubMed 16340109Chan SK, Man DW. Barriers to returning to work for people with spinal cord injuries: a focus group study. Work. 2005;25(4):325-32.
- BackgroundCoetzee, Z. G., C; van der Westhuizen, R; Van Niekerk, L. (2011). Re-conceptualising vocational rehabilitation services towards an inter-sectoral model. South African Journal of Occupational Therapy, 41(2), 32-36.
- BackgroundDepartment of Health (South Africa). (2000). National Rehabilitation Policy. Pretoria: Government Printer.
- Background: PubMed 16955073DeVivo M, Biering-Sorensen F, Charlifue S, Noonan V, Post M, Stripling T, Wing P; Executive Committee for the International SCI Data Sets Committees. International Spinal Cord Injury Core Data Set. Spinal Cord. 2006 Sep;44(9):535-40. doi: 10.1038/sj.sc.3101958.
- Background: PubMed 21135863DeVivo MJ, Biering-Sorensen F, New P, Chen Y; International Spinal Cord Injury Data Set. Standardization of data analysis and reporting of results from the International Spinal Cord Injury Core Data Set. Spinal Cord. 2011 May;49(5):596-9. doi: 10.1038/sc.2010.172. Epub 2010 Dec 7.
- BackgroundDewbury,G., Clarke, K.,Randall, D., Rouncefield, M., Sommerville, I. (2004). The anti-social model of disability Disability and Society 19(2). 145-158.
- BackgroundDomholdt, E. (2005). Rehabilitation Research: Principles and Applications. Third ed. Missouri: Elsevier Saunders.
- Background: PubMed 11586110Dumont RJ, Okonkwo DO, Verma S, Hurlbert RJ, Boulos PT, Ellegala DB, Dumont AS. Acute spinal cord injury, part I: pathophysiologic mechanisms. Clin Neuropharmacol. 2001 Sep-Oct;24(5):254-64. doi: 10.1097/00002826-200109000-00002.
- Background: PubMed 3971241Ekong CE, Tator CH. Spinal cord injury in the work force. Can J Surg. 1985 Mar;28(2):165-7.
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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.
Ntsikelelo Pefile, MScMedSc principal investigator
University of KwaZulu
3 sites 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 Injury, run by University of KwaZulu at 3 sites 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A multidisciplinary model to guide employment amongst people living with spinal cord injuries (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02582619, which also lists 72 linked publications.
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 20 Oct 2021.